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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I (IntePro, US only) | AMS Apogee™ with IntePro(Began May 2006 - Closed) |
| |
| Phase I (InteXen LP, US only) | AMS Apogee™ with InteXen LP (Began May 2006 - Closed) |
| |
| Phase II (France only) | AMS Perigee™ with IntePro (Began February 2007 - Closed) |
| |
| Phase III/IV (Perigee IntePro Lite, US only) | AMS Perigee™ with IntePro Lite (Began April 2007 - Closed) |
| |
| Phase III/IV (Apogee IntePro Lite, US only) | AMS Apogee™ with IntePro Lite (Began April 2007 - Closed) |
| |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posteiror with IntePro Lite (Began April 2008 - Closed) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMS Apogee™ with IntePro | Device | Mesh implant for posterior wall pelvic organ prolapse |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Subjects With an ICS (International Incontinence Society) POP-Q (Pelvic Organ Prolapse Quantification System) Stage of </= Stage I in the Posterior Compartment at One Year Post Procedure | Analysis includes only subjects with posterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. | 12-months |
| Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at One Year Post Procedure | Analysis includes only subjects with uterine descent >= stage II at baselineThe POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. | 12-months |
| Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at One Year Post Procedure | Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method (LFCF). Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | Quality of Life as measure by Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). A higher or increasing score represents an improvement in perceived sexual function versus baseline. Changes in QoL scores between follow-up and baseline were presented. Only those subjects who completed both baseline and follow-up were included. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at 6M Post Procedure | Analysis includes only subjects with uterine descent >= stage II at baselineThe POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. |
Inclusion Criteria:
-Have been diagnosed with one or more clinically significant anterior, apical or posterior genital prolapse disorder(s) (symptomatic POP-Q stage II or higher) requiring surgical repair
Exclusion Criteria:
Not provided
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Adult females ages > 21 years old requiring surgical repair of their genital prolapse
Not provided
| Name | Affiliation | Role |
|---|---|---|
| James C. Lukban, DO | Eastern Virginia Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente - Dept. of Obstetrics & Gynecology | Downey | California | 90242 | United States | ||
| Institute for Women's Health & Body |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22419354 | Result | Lukban JC, Roovers JP, Vandrie DM, Erickson T, Zylstra S, Patel MP, Moore RD. Single-incision apical and posterior mesh repair: 1-year prospective outcomes. Int Urogynecol J. 2012 Oct;23(10):1413-9. doi: 10.1007/s00192-012-1692-4. Epub 2012 Mar 15. | |
| 22190952 | Result | Lukban JC, Beyer RD, Moore RD. Incidence of extrusion following type I polypropylene mesh "kit" repairs in the correction of pelvic organ prolapse. Obstet Gynecol Int. 2012;2012:354897. doi: 10.1155/2012/354897. Epub 2011 Dec 10. |
| Label | URL |
|---|---|
| AMS website | View source |
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Only those subjects who meet all study criteria, provide written consent and are implanted with an AMS PFR System device for prolapse repair will be considered evaluable for analysis in the study
Phases duration:
Phase I: May 2006 - Oct 2009 Phase II: Feb 2007 - Jun 2010 Phase III/IV: Apr 2007 - May 2010 Phase V: Apr 2008 - Jan 2011 Phase VI: Oct 2008 - Mar 2010 Phase VII: Apr 2009 - Feb 2012
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Phase I (IntePro, US Only) | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse |
| FG001 | Phase I (Intexen LP, US Only) | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Phase V (Elevate Posterior InteXen, US only) | AMS Elevate™ Apical & Posteiror with IntXen LP (Began April 2008 - Closed) |
|
| Phase VI (Elevate Anterior Gen 1, For Study Use Only, EU only) | AMS Elevate™ Anterior & Apical with IntePro Lite (Generation 1, For Study Use Only, Began October 2008 - Closed) |
|
| Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite (Generation 2, Began April 2009 - Closed) |
|
| AMS Apogee™ with Intexen LP | Device | Graft implant for posterior wall pelvic organ prolapse |
|
| AMS Perigee™ with IntePro | Device | Mesh implant for anterior wall pelvic organ prolapse |
|
| AMS Perigee™ with IntePro Lite | Device | Mesh implant for anterior wall pelvic organ prolapse |
|
| AMS Apogee™ with IntePro Lite | Device | Mesh implant for posterior wall pelvic organ prolapse |
|
| AMS Elevate™ Apical & Posteiror with IntePro Lite | Device | Mesh implant for apical and posterior wall pelvic organ prolapse |
|
| AMS Elevate™ Apical & Posteiror with IntXen LP | Device | Graft implant for apical and posterior wall pelvic organ prolapse |
|
| AMS Elevate™ Anterior & Apical with IntePro Lite (Gen 1, For Study Use Only) | Device | Mesh implant for anteiror and apical wall pelvic organ prolapse |
|
| AMS Elevate™ Anterior & Apical with IntePro Lite (Gen 2) | Device | Mesh implant for anteiror and apical wall pelvic organ prolapse |
|
| 12-months |
| 6 Months |
| Procedural Time | Procedural time was measured as the time between the first incision to place the study device and the time to close the vaginal incision for the study device. Procedure duration in minutes | Approximately 30 minutes |
| Estimated Blood Loss | Estimated Blood Loss - defined as the estimated blood loss associated with the implantation of the study device, measured in ml | Approximately 30 minutes |
| Percent of Subjects Experiencing Major Device Related Complications | This may have included: perforation of internal organs during the implant procedure; graft erosion; serious infection requiring intravenous antibiotics; death, related to procedure or device; blood loss related to device placement which may have required blood transfusion during the procedure | Through 24 months |
| Rate of Graft Extrusions | Rate of Graft Extrusion pertains to study device graft exposure/protrusion through the vaginal wall | Through 24 months |
| Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Rate of subjects experiencing de novo or worsening urinary and or/ anal incontinence | Through 24 months |
| Wong-Baker Faces Pain Scale at 6 Weeks Post Procedure | Pain - defined as the level of pain or discomfort associated with the pelvic area measured by the Wong-Baker Faces Pain Scale (scale of 0-10, with 10 indicating "hurts worst") at baseline, and 6 weeks post procedure | baseline and 6 weeks |
| Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure. | 6 Months |
| Surgical Revision Rate | The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution. | Through 24 months |
| Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months | The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. | 6 months |
| Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 24 Months | The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. Note:
| 24 months |
| Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure. | 12 months |
| Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) | Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure. Note:
| 24 months |
| Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure. | 6 months |
| Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 12 months post-procedure. | 12 months |
| Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 24 months post-procedure. Note:
| 24 months |
| Patient Satisfaction Questionnaire at 6 Months by Question (Q#3) | Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure. | 6 months |
| Patient Satisfaction Questionnaire at 12 Months by Question (Q#3) | Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 12 months post-procedure. | 12 months |
| Patient Satisfaction Questionnaire at 24 Months by Question (Q#3) | Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 24 months post-procedure. Note:
| 24 months |
| Wong-Baker Faces Pain Scale at 3 Months Post Procedure | Pain - defined as the level of pain or discomfort associated with the pelvic area measured by the Wong-Baker Faces Pain Scale at baseline and 3 months post procedure | baseline and 3 months |
| QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | Quality of Life as measure by Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | 12 months |
| QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | Quality of Life as measure by Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | baseline and 24 months |
| QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 6M | Quality of Life as measure by Pelvic Floor Impact Questionnaire - Short Form 7(PFIQ-7) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. . | baseline and 6 months |
| QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 12M | Quality of Life as measure by Pelvic Floor Impact Questionnaire - Short Form 7(PFIQ-7) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | baseline and 12 months |
| QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 24M | Quality of Life as measure by Pelvic Floor Impact Questionnaire - Short Form 7(PFIQ-7) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | baseline and 24 months |
| QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI (Pelvic Floor Distress Inventory) Sub-scale UDI (Urinary Distress Inventory) at 6M | Quality of Life as measure by PFDI subscale UDI. UDI scale ranges from 0-100 with 100 representing the most urinary distress. Changes in UDI scores between follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | baseline and 6 months |
| QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 12M | Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | baseline and 12 months |
| QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 24M | Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | baseline and 24 months |
| QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 6M | Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | baseline and 6 months |
| QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 6M | Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | baseline and 6 months |
| QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 12M | Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | baseline and 12 months |
| QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 24M | Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | baseline and 24 months |
| QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 12M | Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | baseline and 12 months |
| QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 24M | Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | baseline and 24 months |
| Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 6M Post Procedure | Analysis includes only subjects with posterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. | 6 months |
| Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 24M Post Procedure | Analysis includes only subjects with posterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. | 24 months |
| Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 6M Post Procedure | Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method (LFCF). Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. | 6 months |
| Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 24M Post Procedure | Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method (LFCF). Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. | 24 months |
| 6 months |
| Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at 24M Post Procedure | Analysis includes only subjects with uterine descent >= stage II at baselineThe POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. | 24 months |
| Wellington |
| Florida |
| 33414 |
| United States |
| Atlanta Medical Research Institute | Alpharetta | Georgia | 30005 | United States |
| Rosemark Womencare Specialists | Idaho Falls | Idaho | 83404 | United States |
| Fore River Urology | Portland | Maine | 04102 | United States |
| Maine Medical Partners | Portland | Maine | 04102 | United States |
| Female Pelvic Health | Whitinsville | Massachusetts | 01588 | United States |
| Female Pelvic Medicine and Urogynecology Inst. of Michigan | Grand Rapids | Michigan | 49503 | United States |
| Michigan Medical P.C. | Grand Rapids | Michigan | 49546 | United States |
| Women's Health Care Specialists, PC | Paw Paw | Michigan | 49079 | United States |
| Metro Urology | Plymouth | Minnesota | 55441 | United States |
| Piedmont Urology Associates | Gastonia | North Carolina | 28054 | United States |
| Huey & Weprin Obstetrics & Gynecology | Englewood | Ohio | 45322 | United States |
| South Carolina OB/GYN | Columbia | South Carolina | 29201 | United States |
| University of Tennessee - Dept of Obstetrics & Gynecology | Memphis | Tennessee | 38103 | United States |
| Texas Tech University Health Science Center - OB/GYN Department | El Paso | Texas | 79905 | United States |
| Eastern Virginia Medical School | Norfolk | Virginia | 23507 | United States |
| UZ Leuven Dept of Urology | Leuven | Belgium |
| CMC Beau Soleil | Montpellier | 34070 | France |
| Service urologie de Paris l'Hôpital Tenon | Paris | 75020 | France |
| Hopital Cochin - Saint-Vincent de Paul - Groupement hospitalier universitaire Ouest | Paris | France |
| CHU de Rouen - Pavillon Derocque - Rez de Chaussée | Rouen | 76031 | France |
| Clinique Adassa | Strasbourg | 67082 | France |
| Dr. Rainer Lange | Alzey | 55232 | Germany |
| Beckenbodenzentrum Munich | Munich | 81679 | Germany |
| University of Amsterdam, Academic Medical Center - Department of Gynaecology and Obstetrics | Amsterdam | 1105AZ | Netherlands |
| Hospitalet General de l'Hospitalet | Barcelona | 08906 | Spain |
| University Hospital of Leicester NHS Trust | Leicester | LE5 4PW | United Kingdom |
| 22572917 | Result | Moore RD, Lukban JC. Comparison of vaginal mesh extrusion rates between a lightweight type I polypropylene mesh versus heavier mesh in the treatment of pelvic organ prolapse. Int Urogynecol J. 2012 Oct;23(10):1379-86. doi: 10.1007/s00192-012-1744-9. Epub 2012 May 10. |
| 41204973 | Derived | Schmidbauer L, Liedl B, Goeschen K, Antoniewicz A, Kurtzman J, Wenk MJ. Coexistence of Pelvic Pain, Bladder, and Bowel Symptoms in Women with Pelvic Organ Prolapse: The Effect of Transvaginal Surgery. Int Urogynecol J. 2026 Mar;37(3):691-698. doi: 10.1007/s00192-025-06348-y. Epub 2025 Nov 8. |
| 38153429 | Derived | Liedl B, Barba M, Wenk M. [Pelvic floor reconstruction-update 2024: prolapse-associated symptoms and their treatment]. Urologie. 2024 Jan;63(1):43-50. doi: 10.1007/s00120-023-02247-6. Epub 2023 Dec 28. German. |
| 35347368 | Derived | Himmler M, Gottl K, Witczak M, Yassouridis A, Gold DM, Liedl B. The impact of transvaginal, mesh-augmented level one apical repair on anorectal dysfunction due to pelvic organ prolapse. Int Urogynecol J. 2022 Nov;33(11):3261-3273. doi: 10.1007/s00192-022-05151-3. Epub 2022 Mar 28. |
| FG002 | Phase II (France Only) | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. |
| FG003 | Phase III/IV (Perigee IntePro Lite, US Only) | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| FG004 | Phase III/IV (Apogee IntePro Lite, US Only) | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| FG005 | Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse |
| FG006 | Phase V (Elevate Posterior InteXen LP, US Only) | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse |
| FG007 | Phase VI (Elevate Anterior Gen 1, for Study Use Only, EU Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, for PROPEL study use only) |
| FG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Phase I (IntePro, US Only) | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse |
| BG001 | Phase I (Intexen LP, US Only) | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse |
| BG002 | Phase II (France Only) | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse |
| BG003 | Phase III/IV (Perigee IntePro Lite, US Only) | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| BG004 | Phase III/IV (Apogee IntePro Lite, US Only) | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| BG005 | Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse |
| BG006 | Phase V (Elevate Posterior InteXen LP, US Only) | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse |
| BG007 | Phase VI (Elevate Anterior Gen 1, EU Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) |
| BG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| BG009 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||
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| Primary | Percent of Subjects With an ICS (International Incontinence Society) POP-Q (Pelvic Organ Prolapse Quantification System) Stage of </= Stage I in the Posterior Compartment at One Year Post Procedure | Analysis includes only subjects with posterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. | Analysis conducted only for those subjects with posterior vaginal wall prolapse >= stage II at baseline. Where a "zero" is indicated, no subjects meeting this criteria were enrolled. | Posted | Number | 95% Confidence Interval | percentage of participant | 12-months |
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| Secondary | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | Quality of Life as measure by Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). A higher or increasing score represents an improvement in perceived sexual function versus baseline. Changes in QoL scores between follow-up and baseline were presented. Only those subjects who completed both baseline and follow-up were included. | Changes in QoL scores between follow-up and baseline were presented. Only those subjects who completed both baseline and follow-up were included. | Posted | Mean | Standard Deviation | scores on a scale | 6 Months |
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| Secondary | Procedural Time | Procedural time was measured as the time between the first incision to place the study device and the time to close the vaginal incision for the study device. Procedure duration in minutes | Posted | Mean | Standard Deviation | minutes | Approximately 30 minutes |
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| Secondary | Estimated Blood Loss | Estimated Blood Loss - defined as the estimated blood loss associated with the implantation of the study device, measured in ml | Posted | Mean | Standard Deviation | milliliters | Approximately 30 minutes |
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| Secondary | Percent of Subjects Experiencing Major Device Related Complications | This may have included: perforation of internal organs during the implant procedure; graft erosion; serious infection requiring intravenous antibiotics; death, related to procedure or device; blood loss related to device placement which may have required blood transfusion during the procedure | Total subjects experienced major complications(%) | Posted | Number | Percentage of participants | Through 24 months |
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| Secondary | Rate of Graft Extrusions | Rate of Graft Extrusion pertains to study device graft exposure/protrusion through the vaginal wall | Rate of subjects experiencing graft exposure through the vagina (%) | Posted | Number | Percentage of participants | Through 24 months |
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| Secondary | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Rate of subjects experiencing de novo or worsening urinary and or/ anal incontinence | Rate of subjects experiencing different type of incontinenece (%) | Posted | Number | Percentage of participants | Through 24 months |
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| Secondary | Wong-Baker Faces Pain Scale at 6 Weeks Post Procedure | Pain - defined as the level of pain or discomfort associated with the pelvic area measured by the Wong-Baker Faces Pain Scale (scale of 0-10, with 10 indicating "hurts worst") at baseline, and 6 weeks post procedure | Changes in pain scores between follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | Posted | Mean | Standard Deviation | scores on a scale | baseline and 6 weeks |
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| Secondary | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure. | Overall, what outcome do you feel you have achieved after having this surgery? (% of subjects answering this question) | Posted | Number | Percentage of participants | 6 Months |
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| Secondary | Surgical Revision Rate | The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution. | Percentage of total subjects experienced surgical revision (%) | Posted | Number | Percentage of participants | Through 24 months |
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| Secondary | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months | The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. | POP-Q analysis employed last failure carried forward method, which carries subject's objective failure at previous visits if the results are missing in the visit of interest. It's also considers re-operation for recurrent in study compartment as failure. 95% CI calculated via binominal distribution including only subjects w/POP-Q≥II at baseline. | Posted | Number | 95% Confidence Interval | Percentage of participants | 6 months |
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| Secondary | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 24 Months | The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. Note:
| POP-Q analysis employed last failure carried forward method, which carries subject's objective failure at previous visits if the results are missing in the visit of interest. It's also considers re-operation for recurrent in study compartment as failure. 95% CI calculated via binominal distribution including only subjects w/POP-Q≥II at baseline. | Posted | Number | 95% Confidence Interval | Percentage of participants | 24 months |
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| Secondary | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure. | Overall, what outcome do you feel you have achieved after having this surgery? (% of subjects answering this question) | Posted | Number | Percentage of participants | 12 months |
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| Secondary | Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) | Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure. Note:
| Overall, what outcome do you feel you have achieved after having this surgery? (% of subjects answering this question) | Posted | Number | Percentage of participants | 24 months |
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| Secondary | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure. | How satisfied are you with the outcome of your prolapse surgery? (% of subjects answering this question) | Posted | Number | Percentage of participants | 6 months |
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| Secondary | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 12 months post-procedure. | How satisfied are you with the outcome of your prolapse surgery? (% of subjects answering this question) | Posted | Number | Percentage of participants | 12 months |
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| Secondary | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 24 months post-procedure. Note:
| How satisfied are you with the outcome of your prolapse surgery? (% of subjects answering this question) | Posted | Number | Percentage of participants | 24 months |
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| Secondary | Patient Satisfaction Questionnaire at 6 Months by Question (Q#3) | Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure. | Would you recommend this procedure to a friend suffering from prolapse? (% of subjects answering this question) | Posted | Number | Percentage of participants | 6 months |
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| Secondary | Patient Satisfaction Questionnaire at 12 Months by Question (Q#3) | Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 12 months post-procedure. | Would you recommend this procedure to a friend suffering from prolapse? (% of subjects answering this question) | Posted | Number | Percentage of participants | 12 months |
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| Secondary | Patient Satisfaction Questionnaire at 24 Months by Question (Q#3) | Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 24 months post-procedure. Note:
| Would you recommend this procedure to a friend suffering from prolapse? (% of subjects answering this question) | Posted | Number | Percentage of participants | 24 months |
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| Secondary | Wong-Baker Faces Pain Scale at 3 Months Post Procedure | Pain - defined as the level of pain or discomfort associated with the pelvic area measured by the Wong-Baker Faces Pain Scale at baseline and 3 months post procedure | Changes in pain scores between follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | Posted | Mean | Standard Deviation | Percentage of participants | baseline and 3 months |
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| Secondary | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | Quality of Life as measure by Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | Posted | Mean | Standard Deviation | Percentage of participants | 12 months |
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| Secondary | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | Quality of Life as measure by Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | Posted | Mean | Standard Deviation | Percentage of participants | baseline and 24 months |
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| Secondary | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 6M | Quality of Life as measure by Pelvic Floor Impact Questionnaire - Short Form 7(PFIQ-7) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. . | QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | Posted | Mean | Standard Deviation | Percentage of participants | baseline and 6 months |
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| Secondary | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 12M | Quality of Life as measure by Pelvic Floor Impact Questionnaire - Short Form 7(PFIQ-7) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | Posted | Mean | Standard Deviation | Percentage of participants | baseline and 12 months |
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| Secondary | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 24M | Quality of Life as measure by Pelvic Floor Impact Questionnaire - Short Form 7(PFIQ-7) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | Posted | Mean | Standard Deviation | Percentage of participants | baseline and 24 months |
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| Secondary | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI (Pelvic Floor Distress Inventory) Sub-scale UDI (Urinary Distress Inventory) at 6M | Quality of Life as measure by PFDI subscale UDI. UDI scale ranges from 0-100 with 100 representing the most urinary distress. Changes in UDI scores between follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | Changes in QoL scores between follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | Posted | Mean | Standard Deviation | scores on a scale | baseline and 6 months |
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| Secondary | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 12M | Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | Posted | Mean | Standard Deviation | Percentage of participants | baseline and 12 months |
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| Secondary | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 24M | Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | Posted | Mean | Standard Deviation | Percentage of participants | baseline and 24 months |
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| Secondary | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 6M | Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | Posted | Mean | Standard Deviation | Percentage of participants | baseline and 6 months |
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| Secondary | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 6M | Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | Posted | Mean | Standard Deviation | Percentage of participants | baseline and 6 months |
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| Secondary | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 12M | Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | Posted | Mean | Standard Deviation | Percentage of participants | baseline and 12 months |
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| Secondary | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 24M | Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | Posted | Mean | Standard Deviation | Percentage of participants | baseline and 24 months |
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| Secondary | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 12M | Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | Posted | Mean | Standard Deviation | Percentage of participants | baseline and 12 months |
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| Secondary | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 24M | Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | Posted | Mean | Standard Deviation | Percentage of participants | baseline and 24 months |
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| Primary | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at One Year Post Procedure | Analysis includes only subjects with uterine descent >= stage II at baselineThe POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. | Analysis includes only subjects with uterine descent >=stage II at baseline | Posted | Number | 95% Confidence Interval | percentage of participant | 12-months |
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| Primary | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at One Year Post Procedure | Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method (LFCF). Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. | Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline | Posted | Number | 95% Confidence Interval | percentage of participant | 12-months |
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| Secondary | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 6M Post Procedure | Analysis includes only subjects with posterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. | Analysis includes only subjects with posterior vaginal wall prolapse >= stage II at baseline | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months |
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| Secondary | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 24M Post Procedure | Analysis includes only subjects with posterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. | Analysis includes only subjects with posterior vaginal wall prolapse >= stage II at baseline | Posted | Number | 95% Confidence Interval | percentage of participants | 24 months |
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| Other Pre-specified | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at 6M Post Procedure | Analysis includes only subjects with uterine descent >= stage II at baselineThe POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. | Analysis includes only subjects with uterine descent >=stage II at baseline | Posted | Number | 95% Confidence Interval | Percentage of participants | 6 months |
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| Other Pre-specified | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at 24M Post Procedure | Analysis includes only subjects with uterine descent >= stage II at baselineThe POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. | Analysis includes only subjects with uterine descent >=stage II at baseline | Posted | Number | 95% Confidence Interval | Percentage of participants | 24 months |
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| Secondary | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 6M Post Procedure | Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method (LFCF). Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. | Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months |
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| Secondary | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 24M Post Procedure | Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method (LFCF). Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. | Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline | Posted | Number | 95% Confidence Interval | Percentage of participants | 24 months |
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The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase I (IntePro, US Only) | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | 10 | 141 | 30 | 141 | ||
| EG001 | Phase I (Intexen LP, US Only) | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | 1 | 26 | 3 | 26 | ||
| EG002 | Phase II (France Only) | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV | 11 | 81 | 30 | 81 | ||
| EG003 | Phase III/IV (Perigee IntePro Lite, US Only) | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | 3 | 56 | 20 | 56 | ||
| EG004 | Phase III/IV (Apogee IntePro Lite, US Only) | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | 3 | 55 | 20 | 55 | ||
| EG005 | Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | 8 | 139 | 30 | 139 | ||
| EG006 | Phase V (Elevate Posterior InteXen LP, US Only) | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | 1 | 23 | 3 | 23 | ||
| EG007 | Phase VI (Elevate Anterior Gen 1, EU Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII | 8 | 35 | 7 | 35 | ||
| EG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) | 11 | 142 | 62 | 142 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| any Serious Adverse Event | General disorders | Non-systematic Assessment | Serious Adverse Events are presented as a total. Breaking these SAEs out cannot be accomplished as the study database is not accessible. These SAEs are represented by multiple organ systems |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Infections and infestations | Systematic Assessment | Additional AEs not reported in the secondary endpoints |
| |
| Dyspareunia | Nervous system disorders | Systematic Assessment | Additional AEs not reported in the secondary endpoints |
| |
| Infection- Vaginal | Infections and infestations | Systematic Assessment | Additional AEs not reported in the secondary endpoints |
| |
| Device Malfunction | Surgical and medical procedures | Systematic Assessment | Additional AEs not reported in the secondary endpoints |
| |
| Any non-serious adverse events | General disorders | Systematic Assessment | why cant provide specific ae data? these numbers are a repeat of the data in the non-serious data table |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. James C Lukban, Professor & Director Division of urogynecology | Eastern Virginia Medical School | 7574467900 | lukbanjc@evms.edu |
| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| D011391 | Prolapse |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Male |
|
| Phase VI (Elevate Anterior Gen 1, EU Only) |
AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, for PROPEL study use only) |
| OG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
| Phase III/IV (Perigee IntePro Lite, US Only) |
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG004 | Phase III/IV (Apogee IntePro Lite, US Only) | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG005 | Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse |
| OG006 | Phase V (Elevate Posterior InteXen LP, US Only) | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse |
| OG007 | Phase VI (Elevate Anterior Gen 1, EU Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) |
| OG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
|
|
| OG004 | Phase III/IV (Apogee IntePro Lite, US Only) | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG005 | Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse |
| OG006 | Phase V (Elevate Posterior InteXen LP, US Only) | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse |
| OG007 | Phase VI (Elevate Anterior Gen 1, EU Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) |
| OG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
|
|
| Phase III/IV (Apogee IntePro Lite, US Only) |
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG005 | Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse |
| OG006 | Phase V (Elevate Posterior InteXen LP, US Only) | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse |
| OG007 | Phase VI (Elevate Anterior Gen 1, EU Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) |
| OG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
|
|
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG004 | Phase III/IV (Apogee IntePro Lite, US Only) | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG005 | Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse |
| OG006 | Phase V (Elevate Posterior InteXen LP, US Only) | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse |
| OG007 | Phase VI (Elevate Anterior Gen 1, EU Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII |
| OG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
|
|
| OG004 | Phase III/IV (Apogee IntePro Lite, US Only) | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG005 | Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse |
| OG006 | Phase V (Elevate Posterior InteXen LP, US Only) | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse |
| OG007 | Phase VI (Elevate Anterior Gen 1, EU Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII |
| OG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
|
|
| OG004 | Phase III/IV (Apogee IntePro Lite, US Only) | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG005 | Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse |
| OG006 | Phase V (Elevate Posterior InteXen LP, US Only) | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse |
| OG007 | Phase VI (Elevate Anterior Gen 1, EU Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII |
| OG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
|
|
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
| OG004 | Phase III/IV (Apogee IntePro Lite, US Only) | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG005 | Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse |
| OG006 | Phase V (Elevate Posterior InteXen LP, US Only) | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse |
| OG007 | Phase VI (Elevate Anterior Gen 1, EU Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) |
| OG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
|
|
| OG004 | Phase III/IV (Apogee IntePro Lite, US Only) | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG005 | Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse |
| OG006 | Phase V (Elevate Posterior InteXen LP, US & Only) | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse |
| OG007 | Phase VI (Elevate Anterior Gen 1, EU Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) |
| OG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
|
|
| OG004 | Phase III/IV (Apogee IntePro Lite, US Only) | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG005 | Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse |
| OG006 | Phase V (Elevate Posterior InteXen LP, US Only) | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse |
| OG007 | Phase VI (Elevate Anterior Gen 1, EU Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII |
| OG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
|
|
| OG002 | Phase II (France Only) | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. |
| OG003 | Phase III/IV (Perigee IntePro Lite, US Only) | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG004 | Phase III/IV (Apogee IntePro Lite, US Only) | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG005 | Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse |
| OG006 | Phase V (Elevate Posterior InteXen LP, US Only) | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse |
| OG007 | Phase VI (Elevate Anterior Gen 1, EU Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) |
| OG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
|
|
| OG001 |
| Phase I (Intexen LP, US Only) |
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse |
| OG002 | Phase II (France Only) | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV |
| OG003 | Phase III/IV (Perigee IntePro Lite, US Only) | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG004 | Phase III/IV (Apogee IntePro Lite, US Only) | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG005 | Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse |
| OG006 | Phase V (Elevate Posterior InteXen LP, US Only) | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse |
| OG007 | Phase VI (Elevate Anterior Gen 1, EU Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII |
| OG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
|
|
| OG004 | Phase III/IV (Apogee IntePro Lite, US Only) | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG005 | Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse |
| OG006 | Phase V (Elevate Posterior InteXen LP, US Only) | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse |
| OG007 | Phase VI (Elevate Anterior Gen 1, EU Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII |
| OG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
|
|
| OG003 | Phase III/IV (Perigee IntePro Lite, US Only) | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG004 | Phase III/IV (Apogee IntePro Lite, US Only) | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG005 | Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse |
| OG006 | Phase V (Elevate Posterior InteXen LP, US Only) | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse |
| OG007 | Phase VI (Elevate Anterior Gen 1, EU Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII |
| OG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
|
|
| OG004 | Phase III/IV (Apogee IntePro Lite, US Only) | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG005 | Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse |
| OG006 | Phase V (Elevate Posterior InteXen LP, US Only) | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse |
| OG007 | Phase VI (Elevate Anterior Gen 1, EU Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) |
| OG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
|
|
| OG004 | Phase III/IV (Apogee IntePro Lite, US Only) | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG005 | Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse |
| OG006 | Phase V (Elevate Posterior InteXen LP, US Only) | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse |
| OG007 | Phase VI (Elevate Anterior Gen 1, EU Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) |
| OG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
|
|
| OG003 | Phase III/IV (Perigee IntePro Lite, US Only) | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG004 | Phase III/IV (Apogee IntePro Lite, US Only) | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG005 | Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse |
| OG006 | Phase V (Elevate Posterior InteXen LP, US Only) | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse |
| OG007 | Phase VI (Elevate Anterior Gen 1, EU Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII |
| OG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
|
|
| OG004 | Phase III/IV (Apogee IntePro Lite, US Only) | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG005 | Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse |
| OG006 | Phase V (Elevate Posterior InteXen LP, US Only) | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse |
| OG007 | Phase VI (Elevate Anterior Gen 1, EU Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) |
| OG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
|
|
| OG004 | Phase III/IV (Apogee IntePro Lite, US Only) | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG005 | Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse |
| OG006 | Phase V (Elevate Posterior InteXen LP, US Only) | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse |
| OG007 | Phase VI (Elevate Anterior Gen 1, EU Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) |
| OG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
|
|
| OG003 | Phase III/IV (Perigee IntePro Lite, US Only) | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG004 | Phase III/IV (Apogee IntePro Lite, US Only) | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG005 | Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse |
| OG006 | Phase V (Elevate Posterior InteXen LP, US Only) | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse |
| OG007 | Phase VI (Elevate Anterior Gen 1, EU Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII |
| OG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
|
|
| OG004 | Phase III/IV (Apogee IntePro Lite, US Only) | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG005 | Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse |
| OG006 | Phase V (Elevate Posterior InteXen LP, US Only) | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse |
| OG007 | Phase VI (Elevate Anterior Gen 1, EU Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) |
| OG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
|
|
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG004 | Phase III/IV (Apogee IntePro Lite, US Only) | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG005 | Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse |
| OG006 | Phase V (Elevate Posterior InteXen LP, US Only) | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse |
| OG007 | Phase VI (Elevate Anterior Gen 1, EU Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) |
| OG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
|
|
| OG003 | Phase III/IV (Perigee IntePro Lite, US Only) | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG004 | Phase III/IV (Apogee IntePro Lite, US Only) | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG005 | Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse |
| OG006 | Phase V (Elevate Posterior InteXen LP, US Only) | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse |
| OG007 | Phase VI (Elevate Anterior Gen 1, EU Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII |
| OG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
|
|
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG004 | Phase III/IV (Apogee IntePro Lite, US Only) | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG005 | Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse |
| OG006 | Phase V (Elevate Posterior InteXen LP, US Only) | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse |
| OG007 | Phase VI (Elevate Anterior Gen 1, EU Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) |
| OG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
|
|
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG004 | Phase III/IV (Apogee IntePro Lite, US Only) | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG005 | Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse |
| OG006 | Phase V (Elevate Posterior InteXen LP, US Only) | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse |
| OG007 | Phase VI (Elevate Anterior Gen 1, EU Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) |
| OG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
|
|
| OG003 |
| Phase III/IV (Perigee IntePro Lite, US Only) |
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG004 | Phase III/IV (Apogee IntePro Lite, US Only) | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG005 | Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse |
| OG006 | Phase V (Elevate Posterior InteXen LP, US Only) | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse |
| OG007 | Phase VI (Elevate Anterior Gen 1, EU Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII |
| OG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
|
|
| Phase III/IV (Perigee IntePro Lite, US Only) |
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG004 | Phase III/IV (Apogee IntePro Lite, US Only) | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG005 | Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse |
| OG006 | Phase V (Elevate Posterior InteXen LP, US Only) | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse |
| OG007 | Phase VI (Elevate Anterior Gen 1, EU Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) |
| OG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
|
|
| Phase III/IV (Perigee IntePro Lite, US Only) |
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG004 | Phase III/IV (Apogee IntePro Lite, US Only) | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG005 | Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse |
| OG006 | Phase V (Elevate Posterior InteXen LP, US Only) | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse |
| OG007 | Phase VI (Elevate Anterior Gen 1, EU Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) |
| OG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
|
|
| OG003 | Phase III/IV (Perigee IntePro Lite, US Only) | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG004 | Phase III/IV (Apogee IntePro Lite, US Only) | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG005 | Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse |
| OG006 | Phase V (Elevate Posterior InteXen LP, US Only) | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse |
| OG007 | Phase VI (Elevate Anterior Gen 1, EU Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII |
| OG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
|
|
| Phase III/IV (Perigee IntePro Lite, US Only) |
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG004 | Phase III/IV (Apogee IntePro Lite, US Only) | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG005 | Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse |
| OG006 | Phase V (Elevate Posterior InteXen LP, US Only) | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse |
| OG007 | Phase VI (Elevate Anterior Gen 1, EU Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) |
| OG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
|
|
| Phase III/IV (Perigee IntePro Lite, US Only) |
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG004 | Phase III/IV (Apogee IntePro Lite, US Only) | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG005 | Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse |
| OG006 | Phase V (Elevate Posterior InteXen LP, US Only) | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse |
| OG007 | Phase VI (Elevate Anterior Gen 1, EU Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) |
| OG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
|
|
| Phase III/IV (Perigee IntePro Lite, US Only) |
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG004 | Phase III/IV (Apogee IntePro Lite, US Only) | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG005 | Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse |
| OG006 | Phase V (Elevate Posterior InteXen LP, US Only) | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse |
| OG007 | Phase VI (Elevate Anterior Gen 1, EU Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) |
| OG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
|
|
| OG003 | Phase III/IV (Perigee IntePro Lite, US Only) | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG004 | Phase III/IV (Apogee IntePro Lite, US Only) | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG005 | Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse |
| OG006 | Phase V (Elevate Posterior InteXen LP, US Only) | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse |
| OG007 | Phase VI (Elevate Anterior Gen 1, EU Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII |
| OG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
|
|
| Phase III/IV (Perigee IntePro Lite, US Only) |
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG004 | Phase III/IV (Apogee IntePro Lite, US Only) | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG005 | Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse |
| OG006 | Phase V (Elevate Posterior InteXen LP, US Only) | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse |
| OG007 | Phase VI (Elevate Anterior Gen 1, EU Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) |
| OG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
|
|
| OG003 | Phase III/IV (Perigee IntePro Lite, US Only) | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG004 | Phase III/IV (Apogee IntePro Lite, US Only) | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG005 | Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse |
| OG006 | Phase V (Elevate Posterior InteXen LP, US Only) | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse |
| OG007 | Phase VI (Elevate Anterior Gen 1, EU Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII |
| OG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
|
|
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. |
| OG003 | Phase III/IV (Perigee IntePro Lite, US Only) | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG004 | Phase III/IV (Apogee IntePro Lite, US Only) | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG005 | Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse |
| OG006 | Phase V (Elevate Posterior InteXen LP, US Only) | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse |
| OG007 | Phase VI (Elevate Anterior Gen 1, EU Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) |
| OG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
|
|
| Phase II (France Only) |
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. |
| OG003 | Phase III/IV (Perigee IntePro Lite, US Only) | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG004 | Phase III/IV (Apogee IntePro Lite, US Only) | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG005 | Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse |
| OG006 | Phase V (Elevate Posterior InteXen LP, US Only) | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse |
| OG007 | Phase VI (Elevate Anterior Gen 1, EU Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, Fot PROPEL Study Use Only) |
| OG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
|
|
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. |
| OG003 | Phase III/IV (Perigee IntePro Lite, US Only) | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG004 | Phase III/IV (Apogee IntePro Lite, US Only) | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG005 | Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse |
| OG006 | Phase V (Elevate Posterior InteXen LP, US Only) | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse |
| OG007 | Phase VI (Elevate Anterior Gen 1, EU Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) |
| OG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
|
|
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV |
| OG003 | Phase III/IV (Perigee IntePro Lite, US Only) | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG004 | Phase III/IV (Apogee IntePro Lite, US Only) | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG005 | Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse |
| OG006 | Phase V (Elevate Posterior InteXen LP, US Only) | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse |
| OG007 | Phase VI (Elevate Anterior Gen 1, EU Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII |
| OG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
|
|
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. |
| OG003 | Phase III/IV (Perigee IntePro Lite, US Only) | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG004 | Phase III/IV (Apogee IntePro Lite, US Only) | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG005 | Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse |
| OG006 | Phase V (Elevate Posterior InteXen LP, US Only) | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse |
| OG007 | Phase VI (Elevate Anterior Gen 1, EU Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) |
| OG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
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AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV |
| OG003 | Phase III/IV (Perigee IntePro Lite, US Only) | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG004 | Phase III/IV (Apogee IntePro Lite, US Only) | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG005 | Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse |
| OG006 | Phase V (Elevate Posterior InteXen LP, US Only) | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse |
| OG007 | Phase VI (Elevate Anterior Gen 1, EU Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII |
| OG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
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AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. |
| OG003 | Phase III/IV (Perigee IntePro Lite, US Only) | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG004 | Phase III/IV (Apogee IntePro Lite, US Only) | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG005 | Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse |
| OG006 | Phase V (Elevate Posterior InteXen LP, US Only) | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse |
| OG007 | Phase VI (Elevate Anterior Gen 1, EU Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) |
| OG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
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| Phase II (France Only) |
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV |
| OG003 | Phase III/IV (Perigee IntePro Lite, US Only) | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG004 | Phase III/IV (Apogee IntePro Lite, US Only) | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices |
| OG005 | Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse |
| OG006 | Phase V (Elevate Posterior InteXen LP, US Only) | AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse |
| OG007 | Phase VI (Elevate Anterior Gen 1, EU Only) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII |
| OG008 | Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) |
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