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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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The primary purpose of this randomized clinical trial is to compare the effectiveness and safety of two transvaginal apical suspension strategies for uterovaginal prolapse: a mesh augmented hysteropexy versus vaginal hysterectomy and uterosacral ligament suspension (USLS). The primary aim is to determine whether treatment success in women who undergo the above strategies differ at time points through 3 years.
A supplemental study investigates anterior vaginal wall movement resulting from descent or rotation of the vaginal apex and/or anterior vaginal elongation, in women in both of the study arms of SUPeR.
The study population will be adult women (>21 years of age) with symptomatic uterovaginal prolapse at or beyond the hymen who desire vaginal surgical management. This study is intended to be done only on women who have completed child-bearing and have an inactive uterus, defined as amenorrhea for 1 year. Therefore women will be postmenopausal or will have amenorrhea from an endometrial ablation. Amenorrhea caused from exogenous steroids, or hypothalamic disorders will not allow inclusion.
Participants will be obtained from the clinic population of each of the eight Pelvic Floor Disorders Network (PFDN) sites. Participants will be randomly assigned to have either vaginal hysterectomy and USLS or mesh hysteropexy suspension for treatment of their uterovaginal prolapse. The surgical assignment will be revealed in the operating room, after the participant is under anesthesia.
Participants will be followed for at least 36-months (3-years) post surgery and up to a maximum of 60-months (5-years) during the primary trial. Participants who complete the primary trial will be approached for consent for long-term follow-up as part of a study extension and will be followed up to a maximum of 120-months (10-years). Follow-up data will be obtained during in-person clinic visits, and study staff who are masked to the surgical assignment will be the primary person who obtain follow-up data. Although the primary study outcome does not depend on masked participants and blinded evaluators, several important participant reported secondary aims are subject to reporting bias if the participant is aware of her study assignment. Therefore, study participants, coordinators, and nurses will be masked to the study assignment. Study surgeons and anatomic evaluators will be unmasked. Evaluators conducting the POPQ exam will be a co-investigator, fellow or other qualified nurse who did not perform the study surgery.
Surgical failure rates will be compared using survival analysis approaches appropriate for interval censored data (classic log-rank tests and survival models using a generalized linear model approach with a complementary log-log link) and secondary outcomes will be reported as rates in each group or as group means and evaluated with the appropriate parametric or nonparametric statistical tests.
Throughout the study, the PFDN Data Safety and Monitoring Committee (DSMB) will review study data and decide if the study can or cannot continue. Additionally, this study will adhere to the CONSORT guidelines for performing and reporting randomized controlled trials (Begg et al 1996). Women who are eligible but decline enrollment will be characterized in a manner consistent with CONSORT requirements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hysteropexy | Active Comparator | Uphold® LITE |
|
| Hysterectomy and USLS | Active Comparator | Vaginal hysterectomy and uterosacral ligament suspension (USLS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Uterosacral ligament suspension | Procedure | The USLS procedure used in this protocol is a modification of the technique described by Shull. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Failure | Failure was defined as any of the following: retreatment for prolapse, any POP-Q measure beyond the hymen, or presence of bother on PFDI vaginal bulge question. Under the permanent failure state assumption, the number of participants shown at each visit includes all participants who were still participating in the study or had a failure outcome prior their withdrawal. Similarly, the denominator number of participants for the cumulative failure at each visit includes all participants who were still participating in the study and attended the visit or had any failure outcome prior their withdrawal or missed visit. | 6 Months through 36 Months |
| Measure | Description | Time Frame |
|---|---|---|
| At-visit Failure | Failure was defines as any of the following: retreatment for prolapse, any POP-Q measure beyond the hymen, or presence of bother on PFDI vaginal bulge question. Under the transient failure state assumption, the number of participants shown at each visit includes all participants who were still participating in the study. Similarly, the denominator number of participants for the transient failure at each visit includes all participants who were still participating in the study and attended the visit or who missed the visit but had a retreatment failure outcome prior to their missed visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline PFDI Score | The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1. Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2. Colorectal Anal Distress Inventory (range: 0-100), and 3. Urinary Distress Inventory (range: 0-100). The range of responses on the CRADI is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25 for the scale. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress). Lower scores indicate better function / fewer symptoms. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles W Nager, MD | University of California at San Diego, UCSD Women's Pelvic Medicine Center | Principal Investigator |
| Anthony G Visco, MD | Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery | Principal Investigator |
| Heidi Harvie, MD | University of Pennsylvania | Principal Investigator |
| Marie Paraiso, MD | Cleveland Clinic, Department OB/GYN | Principal Investigator |
| Charles R Rardin, MD | Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery | Principal Investigator |
| Holly E Richter, PhD, MD | University of Alabama at Birmingham, Department of Obstetrics and Gynecology | Principal Investigator |
| Kate Meriwether, MD | University of New Mexico Health Sciences Center, Department of Obstetrics and Gynecology | Principal Investigator |
| Halina M Zyczynski, MD | Magee-Women's Hospital, Department of Obstetrics and Gynecology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham, Department of Obstetrics and Gynecology | Birmingham | Alabama | 35249 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42340704 | Derived | Nager CW, Visco AG, Richter HE, Rardin CR, Meriwether K, Harvie HS, Zyczynski HM, Paraiso MFR, Mazloomdoost D, Sridhar A, Thomas S; Eunice Kennedy Shriver NICHD Pelvic Floor Disorders Network. Sacrospinous Hysteropexy With Mesh vs Vaginal Hysterectomy for Treatment of Uterovaginal Prolapse: 10-Year Results of a Randomized Clinical Trial. JAMA Surg. 2026 Jun 24. doi: 10.1001/jamasurg.2026.2263. Online ahead of print. | |
| 42217015 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hysteropexy | Uphold® LITE Uphold® LITE: The Uphold® procedure used in this protocol is a modification of the technique described by Vu and Goldberg. |
| FG001 | Hysterectomy and USLS | Vaginal hysterectomy and uterosacral ligament suspension (USLS) Uterosacral ligament suspension: The USLS procedure used in this protocol is a modification of the technique described by Shull. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The baseline analysis population comprises all randomized participants that received the assigned intervention and were determined to still be eligible for the intervention after review of the initial POP-Q and PFDI-20.
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| ID | Title | Description |
|---|---|---|
| BG000 | UPHOLD | UPHOLD Procedure |
| BG001 | USLS | Vaginal hysterectomy and Uterosacral Ligament Suspension (USLS) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cumulative Failure | Failure was defined as any of the following: retreatment for prolapse, any POP-Q measure beyond the hymen, or presence of bother on PFDI vaginal bulge question. Under the permanent failure state assumption, the number of participants shown at each visit includes all participants who were still participating in the study or had a failure outcome prior their withdrawal. Similarly, the denominator number of participants for the cumulative failure at each visit includes all participants who were still participating in the study and attended the visit or had any failure outcome prior their withdrawal or missed visit. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline. | Posted | Count of Participants | Participants | 6 Months through 36 Months |
|
36 Months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hysterectomy | Vaginal hysterectomy and Uterosacral Ligament Suspension (USLS) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marie Gantz | RTI International | 919-541-5110 | mgantz@rti.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 9, 2020 | Jan 7, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 15, 2018 | Jan 7, 2021 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 21, 2016 | May 16, 2025 | ICF_002.pdf |
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| Uphold® LITE | Procedure | The Uphold® procedure used in this protocol is a modification of the technique described by Vu and Goldberg. |
|
| 6 months through 36 Months |
| 6, 12, 18, 24, and 36 Months |
| Change From Baseline CRADI Score | The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1. Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2. Colorectal Anal Distress Inventory (range: 0-100), and 3. Urinary Distress Inventory (range: 0-100). The range of responses on the CRADI is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25 for the scale. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress). Lower scores indicate better function / fewer symptoms. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score). | 6, 12, 18, 24, and 36 Months |
| Change From Baseline POPDI Score | The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1. Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2. Colorectal Anal Distress Inventory (range: 0-100), and 3. Urinary Distress Inventory (range: 0-100). The range of responses on the CRADI is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25 for the scale. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress). Lower scores indicate better function / fewer symptoms. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score). | 6, 12, 18, 24, and 36 Months |
| Change From Baseline UDI Score | The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1. Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2. Colorectal Anal Distress Inventory (range: 0-100), and 3. Urinary Distress Inventory (range: 0-100). The range of responses on the CRADI is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25 for the scale. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress). Lower scores indicate better function / fewer symptoms. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score). | 6, 12, 18, 24, and 36 Months |
| Change From Baseline PFIQ Score | The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman''s daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). The range of responses on the CRAIQ is 0-3 with (0) Not at all, (1) Somewhat, (2) Moderately, and (3), Quite a bit. Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Lower scores indicate better function / fewer symptoms. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score). | 6, 12, 18, 24, and 36 Months |
| Change From Baseline CRAIQ Score | The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman''s daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). The range of responses on the CRAIQ is 0-3 with (0) Not at all, (1) Somewhat, (2) Moderately, and (3), Quite a bit. Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Lower scores indicate better function / fewer symptoms. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score). | 6, 12, 18, 24, and 36 Months |
| Change From Baseline POPIQ Score | The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman''s daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). The range of responses on the CRAIQ is 0-3 with (0) Not at all, (1) Somewhat, (2) Moderately, and (3), Quite a bit. Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Lower scores indicate better function / fewer symptoms. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score). | 6, 12, 18, 24, and 36 Months |
| Change From Baseline UIQ Score | The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman''s daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). The range of responses on the CRAIQ is 0-3 with (0) Not at all, (1) Somewhat, (2) Moderately, and (3), Quite a bit. Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Lower scores indicate better function / fewer symptoms. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score). | 6, 12, 18, 24, and 36 Months |
| Change From Baseline Incontinence Severity Index | Incontinence Severity Index measuring the severity of urinary incontinence is composed of 2 questions: frequency of leakage (0=Never,...,4=Every day/night) and amount of urine leakage (1=Drops, 2=small splashes, 3= More). The index score is calculated categorizing the product of the two responses. The range of responses is: 0 (no incontinence) to 12 (severe incontinence). Lower index scores indicate better function / fewer symptoms. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score). | 6, 12, 18, 24, and 36 Months |
| Change From Baseline Functional Activity Scale | Functional Activity Scale measuring the impact of incontinence symptoms on a woman''s daily activities is composed of 13 questions about normal and physically strenuous daily activities. The range of responses on the individual questions is (1) No difficulty,... (5) Not able to do it. Scores are calculated by subtracting from the maximum sum (5*13=65) the product of the mean response and number of questions, then dividing by the total range of sums (65 - 13 = 52) and multiplying by 100. The range of responses is: 0-100 with 0 (worse functionality) to 100 (Better functionality). Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score). | 6, 12, 18, 24, and 36 Months |
| Change From Baseline Body Part Pain Scale | The Body Part Pain Scale measuring the the pain experienced in the lower abdomen and pelvic region of the body is composed of 7 questions, each with a yes (1) or no (0) questions about experiencing pain followed by an intensity rating: 0 (No pain),..., 10 (Most intense). The score is calculated as the average of the responses. The range of responses is: 0-10 with 0 (No pain) to 10 (most intense pain). Lower scores indicate better function / fewer symptoms. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score). | 6, 12, 18, 24, 30, and 36 Months |
| Change From Baseline Surgical Pain Scale Rest Score | The Surgical Pain Scale measuring the post-surgical pain experienced by a subject is composed of 4 questions: Pain at Rest (range 0-10), Pain with Normal Activities (range 0-10), Pain with Exercise (range 0-10), and Intensity of Worst Pain (range 0-10). Lower scores indicate better less pain. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score). | 6, 12, 18, 24, and 36 Months |
| Change From Baseline Surgical Pain Scale Normal Score | The Surgical Pain Scale measuring the post-surgical pain experienced by a subject is composed of 4 questions: Pain at Rest (range 0-10), Pain with Normal Activities (range 0-10), Pain with Exercise (range 0-10), and Intensity of Worst Pain (range 0-10). Lower scores indicate better less pain. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score). | 6, 12, 18, 24, and 36 Months |
| Change From Baseline Surgical Pain Scale Exercise Score | The Surgical Pain Scale measuring the post-surgical pain experienced by a subject is composed of 4 questions: Pain at Rest (range 0-10), Pain with Normal Activities (range 0-10), Pain with Exercise (range 0-10), and Intensity of Worst Pain (range 0-10). Lower scores indicate better less pain. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score). | 6, 12, 18, 24, and 36 Months |
| Change From Baseline Surgical Pain Scale Worst Score | The Surgical Pain Scale measuring the post-surgical pain experienced by a subject is composed of 4 questions: Pain at Rest (range 0-10), Pain with Normal Activities (range 0-10), Pain with Exercise (range 0-10), and Intensity of Worst Pain (range 0-10). Lower scores indicate better less pain. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score). | 6, 12, 18, 24, and 36 Months |
| Change From Baseline Body Image Scale | The Body Image Scale measuring how the subjects feel about their appearance and about any changes that may have resulted from their condition consists of 8 questions. The questions are scored from 0=Not at all,..., 3=Very much. The score is calculated by summing the responses and ranges from 0 to 24. Higher scores correspond to worse body image. Change = Month [6, 12, 18, 24, and 36] Score - Baseline Score. | 6, 12, 18, 24, and 36 Months |
| Change From Baseline PISQ-IR Sexually Active Average Score | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. The PISQ-IR Sexually Active-Average Score (SA-AVG) ranges from 0 to 5 with higher scores indicating better function/satisfaction. The change from baseline outcome is calculated as the difference in score at 6, 12, 18, 24, and 36 months and the score at baseline. | 6, 12, 18, 24, and 36 Months |
| POP-Q Ba Measurement | The Pelvic Organ Prolapse Quantification (POPQ) Point Ba represents the most distal (i.e. most dependent) position of any part of the upper anterior vaginal wall (between the vaginal cuff or anterior vaginal fornix and Point Aa). Point Ba coincides with Point Aa (-3 cm) in a woman who has no anterior POP. In a woman with severe POP, Ba coincides with Point C. | 12, 24, and 36 Months |
| POP-Q Bp Measurement | The Pelvic Organ Prolapse Quantification (POPQ) Point Bp represents the most distal position of any part of the upper posterior vaginal wall (between the vaginal cuff or posterior vaginal fornix and Point Ap). | 12, 24, and 36 Months |
| POP-Q C Measurement | The Pelvic Organ Prolapse Quantification (POPQ) Point C is measured in cm relative to the hymen with negative values being proximal to the hymen and positive values distal to the hymen. Point C represents either the most distal edge of the cervix or the leading edge of the vaginal cuff after total hysterectomy. | 12, 24, and 36 Months |
| POP-Q TVL Measurement | The Pelvic Organ Prolapse Quantification (POPQ) Total Vaginal Length (TVL) is the length of the vagina from posterior fornix tothe hymen when Point C or D is reduced to its full normal position. | 12, 24, and 36 Months |
| PGI-I | The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse). Included here are participants who had improvement as indicated by a rating of 1 (very much better), 2 (much better). | 6,12, 18, 24, and 36 Months |
| Sonia Thomas, DrPH |
| RTI International |
| Principal Investigator |
| University of California at San Diego, UCSD Women's Pelvic Medicine Center |
| La Jolla |
| California |
| 92037-0974 |
| United States |
| University of New Mexico Health Sciences Center, Department of Obstetrics and Gynecology | Albuquerque | New Mexico | 87131 | United States |
| Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery | Durham | North Carolina | 27707 | United States |
| Cleveland Clinic, Department OB/GYN | Cleveland | Ohio | 44195 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Magee-Women's Hospital, Department of Obstetrics and Gynecology | Pittsburgh | Pennsylvania | 15213 | United States |
| Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery | Providence | Rhode Island | 02903 | United States |
| Derived |
| Lockhart ME, Moalli PA, Richter HE, Meyer I, Weidner AC, Komesu YM, Carper B, Gantz MG; Eunice Kennedy Shriver NICHD Pelvic Floor Disorders Network. MRI 2-D Parameters Associated with Native Tissue or Transvaginal Mesh Surgical Apical Prolapse Repair Failure. Int Urogynecol J. 2026 May 30. doi: 10.1007/s00192-026-06699-0. Online ahead of print. |
| 36701331 | Derived | Bradley MS, Sridhar A, Ferrante K, Andy UU, Visco AG, Florian-Rodriguez ME, Myers D, Varner E, Mazloomdoost D, Gantz MG; NICHD Pelvic Floor Disorders Network. Association Between Enlarged Genital Hiatus and Composite Surgical Failure After Vaginal Hysterectomy With Uterosacral Ligament Suspension. Urogynecology (Phila). 2023 May 1;29(5):479-488. doi: 10.1097/SPV.0000000000001309. Epub 2022 Dec 23. |
| 36449027 | Derived | Napoe GS, Luchristt D, Sridhar A, Ellington D, Ridgeway B, Mazloomdoost D, Sung V, Ninivaggio C, Harvie H, Santiago-Lastra Y, Gantz MG, Zyczynski HM. Reoperation for prolapse recurrence after sacrospinous mesh hysteropexy: characteristics of women choosing retreatment. Int Urogynecol J. 2023 Jan;34(1):255-261. doi: 10.1007/s00192-022-05411-2. Epub 2022 Nov 30. |
| 33716071 | Derived | Nager CW, Visco AG, Richter HE, Rardin CR, Komesu Y, Harvie HS, Zyczynski HM, Paraiso MFR, Mazloomdoost D, Sridhar A, Thomas S; National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Effect of sacrospinous hysteropexy with graft vs vaginal hysterectomy with uterosacral ligament suspension on treatment failure in women with uterovaginal prolapse: 5-year results of a randomized clinical trial. Am J Obstet Gynecol. 2021 Aug;225(2):153.e1-153.e31. doi: 10.1016/j.ajog.2021.03.012. Epub 2021 Mar 12. |
| 32769645 | Derived | Lukacz ES, Sridhar A, Chermansky CJ, Rahn DD, Harvie HS, Gantz MG, Varner RE, Korbly NB, Mazloomdoost D; Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network (PFDN). Sexual Activity and Dyspareunia 1 Year After Surgical Repair of Pelvic Organ Prolapse. Obstet Gynecol. 2020 Sep;136(3):492-500. doi: 10.1097/AOG.0000000000003992. |
| 31529008 | Derived | Nager CW, Visco AG, Richter HE, Rardin CR, Rogers RG, Harvie HS, Zyczynski HM, Paraiso MFR, Mazloomdoost D, Grey S, Sridhar A, Wallace D; NICHD Pelvic Floor Disorders Network. Effect of Vaginal Mesh Hysteropexy vs Vaginal Hysterectomy With Uterosacral Ligament Suspension on Treatment Failure in Women With Uterovaginal Prolapse: A Randomized Clinical Trial. JAMA. 2019 Sep 17;322(11):1054-1065. doi: 10.1001/jama.2019.12812. |
| Ineligible |
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Current Smoker | Count of Participants | Participants |
|
| Number of Pregnancies | Median | Full Range | Number of pregnancies |
|
| Number of Vaginal Deliveries | Median | Full Range | Number of deliveries |
|
| Menstrual Status | Count of Participants | Participants |
|
| POP-Q Ba | Pelvic Organ Prolapse Quantification System (POP-Q) Point Ba represents the most distal (i.e. most dependent) position of any part of the upper anterior vaginal wall (between the vaginal cuff or anterior vaginal fornix and Point Aa). Point Ba coincides with Point Aa (-3 cm) in a woman who has no anterior POP. In a woman with severe POP, Ba coincides with Point C. | Mean | Standard Deviation | cm |
|
| POP-Q Bp | POP-Q Point Bp represents the most distal position of any part of the upper posterior vaginal wall (between the vaginal cuff or posterior vaginal fornix and Point Ap). | Mean | Standard Deviation | cm |
|
| POP-Q C | POP-Q Point C is measured in cm relative to the hymen with negative values being proximal to the hymen and positive values distal to the hymen. Point C represents either the most distal edge of the cervix or the leading edge of the vaginal cuff after total hysterectomy. | Mean | Standard Deviation | cm |
|
| POP-Q TVL | The POP-Q TVL (total vaginal length) is the length of the vagina (cm) from posterior fornix to hymen when Point C or D is reduced to its full normal position. | Mean | Standard Deviation | cm |
|
| POP-Q Stage | The POP-Q is summarized by stages in which higher stages indicate worse prolapse: Stage 0: No prolapse is demonstrated. Stage 1: The most distal portion of the prolapse is more than 1 cm above the level of the hymen. Stage 2: The most distal portion of the prolapse is between 1 cm above the hymen and 1 cm below the hymen. Stage 3: The most distal portion of the prolapse is more than 1 cm beyond the plane of the hymen, but not further than 2 cm less than the TVL. Stage 4: Complete eversion or eversion to within 2 cm of the TVL. | Count of Participants | Participants |
|
UPHOLD Procedure |
| OG001 | USLS | Vaginal hysterectomy and Uterosacral Ligament Suspension (USLS) |
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| Secondary | At-visit Failure | Failure was defines as any of the following: retreatment for prolapse, any POP-Q measure beyond the hymen, or presence of bother on PFDI vaginal bulge question. Under the transient failure state assumption, the number of participants shown at each visit includes all participants who were still participating in the study. Similarly, the denominator number of participants for the transient failure at each visit includes all participants who were still participating in the study and attended the visit or who missed the visit but had a retreatment failure outcome prior to their missed visit. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline. | Posted | Count of Participants | Participants | 6 months through 36 Months |
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| Other Pre-specified | Change From Baseline PFDI Score | The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1. Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2. Colorectal Anal Distress Inventory (range: 0-100), and 3. Urinary Distress Inventory (range: 0-100). The range of responses on the CRADI is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25 for the scale. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress). Lower scores indicate better function / fewer symptoms. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score). | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 6, 12, 18, 24, and 36 Months |
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| Other Pre-specified | Change From Baseline CRADI Score | The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1. Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2. Colorectal Anal Distress Inventory (range: 0-100), and 3. Urinary Distress Inventory (range: 0-100). The range of responses on the CRADI is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25 for the scale. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress). Lower scores indicate better function / fewer symptoms. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score). | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 6, 12, 18, 24, and 36 Months |
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| Other Pre-specified | Change From Baseline POPDI Score | The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1. Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2. Colorectal Anal Distress Inventory (range: 0-100), and 3. Urinary Distress Inventory (range: 0-100). The range of responses on the CRADI is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25 for the scale. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress). Lower scores indicate better function / fewer symptoms. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score). | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 6, 12, 18, 24, and 36 Months |
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| Other Pre-specified | Change From Baseline UDI Score | The Pelvic Floor Distress Inventory is a 20-question, validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of an overall scale (range: 0-300) comprised of 3 sub-scales: 1. Pelvic Organ Prolapse Distress Inventory (range: 0-100), 2. Colorectal Anal Distress Inventory (range: 0-100), and 3. Urinary Distress Inventory (range: 0-100). The range of responses on the CRADI is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25 for the scale. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress). Lower scores indicate better function / fewer symptoms. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score). | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 6, 12, 18, 24, and 36 Months |
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| Other Pre-specified | Change From Baseline PFIQ Score | The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman''s daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). The range of responses on the CRAIQ is 0-3 with (0) Not at all, (1) Somewhat, (2) Moderately, and (3), Quite a bit. Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Lower scores indicate better function / fewer symptoms. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score). | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 6, 12, 18, 24, and 36 Months |
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| Other Pre-specified | Change From Baseline CRAIQ Score | The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman''s daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). The range of responses on the CRAIQ is 0-3 with (0) Not at all, (1) Somewhat, (2) Moderately, and (3), Quite a bit. Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Lower scores indicate better function / fewer symptoms. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score). | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 6, 12, 18, 24, and 36 Months |
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| Other Pre-specified | Change From Baseline POPIQ Score | The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman''s daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). The range of responses on the CRAIQ is 0-3 with (0) Not at all, (1) Somewhat, (2) Moderately, and (3), Quite a bit. Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Lower scores indicate better function / fewer symptoms. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score). | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 6, 12, 18, 24, and 36 Months |
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| Other Pre-specified | Change From Baseline UIQ Score | The Pelvic Floor Impact Questionnaire short form (PFIQ-7) measuring the impact of bladder, bowel, and vaginal symptoms on a woman''s daily activities, relationships and emotions is composed of 3 scales of 7 questions each: the Urinary Impact Questionnaire (UIQ; range 0-100), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; range 0-100), and the Colorectal-Anal Impact Questionnaire (CRAIQ; range 0-100). The range of responses on the CRAIQ is 0-3 with (0) Not at all, (1) Somewhat, (2) Moderately, and (3), Quite a bit. Scores are calculated by multiplying the mean value of all answered questions for a scale by 100 divided by 3. The range of responses is: 0-100 with 0 (least negative impact) to 100 (most negative impact). Lower scores indicate better function / fewer symptoms. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score). | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 6, 12, 18, 24, and 36 Months |
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| Other Pre-specified | Change From Baseline Incontinence Severity Index | Incontinence Severity Index measuring the severity of urinary incontinence is composed of 2 questions: frequency of leakage (0=Never,...,4=Every day/night) and amount of urine leakage (1=Drops, 2=small splashes, 3= More). The index score is calculated categorizing the product of the two responses. The range of responses is: 0 (no incontinence) to 12 (severe incontinence). Lower index scores indicate better function / fewer symptoms. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score). | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 6, 12, 18, 24, and 36 Months |
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| Other Pre-specified | Change From Baseline Functional Activity Scale | Functional Activity Scale measuring the impact of incontinence symptoms on a woman''s daily activities is composed of 13 questions about normal and physically strenuous daily activities. The range of responses on the individual questions is (1) No difficulty,... (5) Not able to do it. Scores are calculated by subtracting from the maximum sum (5*13=65) the product of the mean response and number of questions, then dividing by the total range of sums (65 - 13 = 52) and multiplying by 100. The range of responses is: 0-100 with 0 (worse functionality) to 100 (Better functionality). Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score). | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 6, 12, 18, 24, and 36 Months |
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| Other Pre-specified | Change From Baseline Body Part Pain Scale | The Body Part Pain Scale measuring the the pain experienced in the lower abdomen and pelvic region of the body is composed of 7 questions, each with a yes (1) or no (0) questions about experiencing pain followed by an intensity rating: 0 (No pain),..., 10 (Most intense). The score is calculated as the average of the responses. The range of responses is: 0-10 with 0 (No pain) to 10 (most intense pain). Lower scores indicate better function / fewer symptoms. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score). | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 6, 12, 18, 24, 30, and 36 Months |
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| Other Pre-specified | Change From Baseline Surgical Pain Scale Rest Score | The Surgical Pain Scale measuring the post-surgical pain experienced by a subject is composed of 4 questions: Pain at Rest (range 0-10), Pain with Normal Activities (range 0-10), Pain with Exercise (range 0-10), and Intensity of Worst Pain (range 0-10). Lower scores indicate better less pain. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score). | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 6, 12, 18, 24, and 36 Months |
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| Other Pre-specified | Change From Baseline Surgical Pain Scale Normal Score | The Surgical Pain Scale measuring the post-surgical pain experienced by a subject is composed of 4 questions: Pain at Rest (range 0-10), Pain with Normal Activities (range 0-10), Pain with Exercise (range 0-10), and Intensity of Worst Pain (range 0-10). Lower scores indicate better less pain. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score). | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 6, 12, 18, 24, and 36 Months |
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| Other Pre-specified | Change From Baseline Surgical Pain Scale Exercise Score | The Surgical Pain Scale measuring the post-surgical pain experienced by a subject is composed of 4 questions: Pain at Rest (range 0-10), Pain with Normal Activities (range 0-10), Pain with Exercise (range 0-10), and Intensity of Worst Pain (range 0-10). Lower scores indicate better less pain. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score). | AAn intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline. This outcome measure is only calculated for individuals who reported exercising. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 6, 12, 18, 24, and 36 Months |
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| Other Pre-specified | Change From Baseline Surgical Pain Scale Worst Score | The Surgical Pain Scale measuring the post-surgical pain experienced by a subject is composed of 4 questions: Pain at Rest (range 0-10), Pain with Normal Activities (range 0-10), Pain with Exercise (range 0-10), and Intensity of Worst Pain (range 0-10). Lower scores indicate better less pain. Change = (Month [6, 12, 18, 24, and 36] Score - Baseline Score). | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 6, 12, 18, 24, and 36 Months |
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| Other Pre-specified | Change From Baseline Body Image Scale | The Body Image Scale measuring how the subjects feel about their appearance and about any changes that may have resulted from their condition consists of 8 questions. The questions are scored from 0=Not at all,..., 3=Very much. The score is calculated by summing the responses and ranges from 0 to 24. Higher scores correspond to worse body image. Change = Month [6, 12, 18, 24, and 36] Score - Baseline Score. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 6, 12, 18, 24, and 36 Months |
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| Other Pre-specified | Change From Baseline PISQ-IR Sexually Active Average Score | The Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-revised (PISQ-IR) is a questionnaire measuring the impact of incontinence symptoms on sexual function and satisfaction. The PISQ-IR Sexually Active-Average Score (SA-AVG) ranges from 0 to 5 with higher scores indicating better function/satisfaction. The change from baseline outcome is calculated as the difference in score at 6, 12, 18, 24, and 36 months and the score at baseline. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline. This outcome measure is only calculated for individuals who report being sexually active. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | 6, 12, 18, 24, and 36 Months |
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| Other Pre-specified | POP-Q Ba Measurement | The Pelvic Organ Prolapse Quantification (POPQ) Point Ba represents the most distal (i.e. most dependent) position of any part of the upper anterior vaginal wall (between the vaginal cuff or anterior vaginal fornix and Point Aa). Point Ba coincides with Point Aa (-3 cm) in a woman who has no anterior POP. In a woman with severe POP, Ba coincides with Point C. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline. | Posted | Mean | 95% Confidence Interval | cm | 12, 24, and 36 Months |
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| Other Pre-specified | POP-Q Bp Measurement | The Pelvic Organ Prolapse Quantification (POPQ) Point Bp represents the most distal position of any part of the upper posterior vaginal wall (between the vaginal cuff or posterior vaginal fornix and Point Ap). | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline. | Posted | Mean | 95% Confidence Interval | cm | 12, 24, and 36 Months |
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| Other Pre-specified | POP-Q C Measurement | The Pelvic Organ Prolapse Quantification (POPQ) Point C is measured in cm relative to the hymen with negative values being proximal to the hymen and positive values distal to the hymen. Point C represents either the most distal edge of the cervix or the leading edge of the vaginal cuff after total hysterectomy. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline. | Posted | Mean | 95% Confidence Interval | cm | 12, 24, and 36 Months |
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| Other Pre-specified | POP-Q TVL Measurement | The Pelvic Organ Prolapse Quantification (POPQ) Total Vaginal Length (TVL) is the length of the vagina from posterior fornix tothe hymen when Point C or D is reduced to its full normal position. | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline. | Posted | Mean | 95% Confidence Interval | cm | 12, 24, and 36 Months |
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| Other Pre-specified | PGI-I | The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse). Included here are participants who had improvement as indicated by a rating of 1 (very much better), 2 (much better). | An intent-to-treat (ITT) analysis which included all eligible participants who were randomized and received the assigned treatment. Participants were included at each time point at which they provided outcome data after baseline. | Posted | Count of Participants | Participants | 6,12, 18, 24, and 36 Months |
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| 2 |
| 90 |
| 10 |
| 90 |
| 73 |
| 90 |
| EG001 | Hysteropexy | UPHOLD Procedure | 1 | 93 | 10 | 93 | 73 | 93 |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Diverticular perforation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Urosepsis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Bladder spasm | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
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| Stress urinary incontinence | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
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| Dyspareunia | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
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| Rectocele | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
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| Vulvovaginal pain | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Enteritis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Faecal incontinence | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Gastric ulcer | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Levator syndrome | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Peritoneal perforation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Device malfunction | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Feeling hot | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Local swelling | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Bacterial vaginosis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Clostridium difficile colitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Fungal infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Groin abscess | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Vaginal infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Vulvovaginal candidiasis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Wound infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Bladder injury | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| Femoral nerve injury | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| Hysteropexy mesh exposure | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| Midurethral sling mesh exposure | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| Postoperative thrombosis | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| Procedural complication | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| Retained fragment of surgical packing | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| Suture exposure after 12 wks. | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| Ureteric kink | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| Vaginal laceration | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| Blood culture positive | Investigations | MedDRA 17.1 | Systematic Assessment |
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| Urine analysis abnormal | Investigations | MedDRA 17.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Sciatica | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Bladder spasm | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
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| Hydronephrosis | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
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| Nocturia | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
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| Stress urinary incontinence | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
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| Urethral caruncle | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
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| Urethral cyst | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
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| Urethral pain | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
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| Urge incontinence | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
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| Urinary incontinence | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
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| Atrophic vulvovaginitis | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
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| Bartholin's cyst | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
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| Cervical polyp | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
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| Dyspareunia | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
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| Fallopian tube prolapse | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
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| Pelvic pain | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
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| Perineal pain | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
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| Postmenopausal bleeding secondary to atrophy | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
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| Postmenopausal haemorrhage | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
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| Rectocele | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
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| Uterine haemorrhage | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
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| Vaginal bleeding | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
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| Vaginal erosion | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
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| Vaginal haematoma | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
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| Vaginal scarring | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
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| Vaginotomy | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
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| Vulvovaginal adhesion | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
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| Vulvovaginal discomfort | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
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| Vulvovaginal pain | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
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| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
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| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Excessive granulation tissue after 12 wks. | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Ureteral stent insertion | Surgical and medical procedures | MedDRA 17.1 | Systematic Assessment |
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| Phlebitis | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
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Not provided
Not provided
| Failure |
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| Failure |
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| Failure |
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| Failure |
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| Failure |
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| Failure |
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| 12 Months |
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| 18 Months |
|
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| 24 Months |
|
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| 30 Months |
|
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| 36 Months |
|
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| 12 Months |
|
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| 18 Months |
|
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| 24 Months |
|
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| 36 Months |
|
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| 12 Months |
|
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| 18 Months |
|
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| 24 Months |
|
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| 36 Months |
|
|
| 12 Months |
|
|
| 18 Months |
|
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| 24 Months |
|
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| 36 Months |
|
|
| 12 Months |
|
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| 18 Months |
|
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| 24 Months |
|
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| 36 Months |
|
|
| 12 Months |
|
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| 18 Months |
|
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| 24 Months |
|
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| 36 Months |
|
|
| 12 Months |
|
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| 18 Months |
|
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| 24 Months |
|
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| 36 Months |
|
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| 12 Months |
|
|
| 18 Months |
|
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| 24 Months |
|
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| 36 Months |
|
|
| 12 Months |
|
|
| 18 Months |
|
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| 24 Months |
|
|
| 36 Months |
|
|
| 12 Months |
|
|
| 18 Months |
|
|
| 24 Months |
|
|
| 36 Months |
|
|
| 12 Months |
|
|
| 18 Months |
|
|
| 24 Months |
|
|
| 36 Months |
|
|
| 12 Months |
|
|
| 18 Months |
|
|
| 24 Months |
|
|
| 30 Months |
|
|
| 36 Months |
|
|
| 12 Months |
|
|
| 18 Months |
|
|
| 24 Months |
|
|
| 36 Months |
|
|
| 12 Months |
|
|
| 18 Months |
|
|
| 24 Months |
|
|
| 36 Months |
|
|
| 12 Months |
|
|
| 18 Months |
|
|
| 24 Months |
|
|
| 36 Months |
|
|
| 12 Months |
|
|
| 18 Months |
|
|
| 24 Months |
|
|
| 36 Months |
|
|
| 12 Months |
|
|
| 18 Months |
|
|
| 24 Months |
|
|
| 36 Months |
|
|
| 12 Months |
|
|
| 18 Months |
|
|
| 24 Months |
|
|
| 36 Months |
|
|
| 24 Months |
|
|
| 36 Months |
|
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| 24 Months |
|
|
| 36 Months |
|
|
| 24 Months |
|
|
| 36 Months |
|
|
| 24 Months |
|
|
| 36 Months |
|
|
| Improved |
|
| 12 Months |
|
|
| 18 Months |
|
|
| 24 Months |
|
|
| 36 Months |
|
|