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The primary aim of this double-blind, randomized clinical trial (RCT) is to test the hypothesis that the addition of a standardized technique of interpositional synthetic polypropylene mesh placement improves the one-year outcome of vaginal reconstructive surgery for pelvic organ prolapse compared to traditional vaginal reconstructive surgery without mesh.
Minimally invasive surgical procedures using mesh have rapidly developed in the field of pelvic floor reconstruction. Unfortunately, safety and efficacy data have lagged behind the technical advancements. No randomized controlled trials of different vaginal apical suspension procedures have been reported. The use of synthetic vaginal mesh has evolved due to the 20-30% recurrence rate for conventional pelvic reconstructive surgeries. This trial will examine synthetic monofilament polypropylene mesh use in vaginal reconstructive surgery for vaginal Stage II-IV prolapse.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prolift mesh | Active Comparator | vaginal prolapse repair with mesh |
|
| Prolapse repair without mesh | Active Comparator | vaginal prolapse repair without mesh |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| synthetic monofilament polypropylene mesh | Device | Vaginal prolapse repair with mesh |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Anatomic Cure at 3 Years | 3 different measures for Anatomic cure using POPQ measurements:
Patient Satisfaction using Patient Global Impression of Improvement with response of very much better or much better | 3 year |
| Measure | Description | Time Frame |
|---|---|---|
| Bothersome Dyspareunia | Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire question 5 response of usually or always and tracked resolution, persistence, de novo dyspareunia | 3 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cheryl Iglesia, MD | Medstar Health Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24084533 | Derived | Gutman RE, Nosti PA, Sokol AI, Sokol ER, Peterson JL, Wang H, Iglesia CB. Three-year outcomes of vaginal mesh for prolapse: a randomized controlled trial. Obstet Gynecol. 2013 Oct;122(4):770-777. doi: 10.1097/AOG.0b013e3182a49dac. | |
| 20664388 | Derived | Iglesia CB, Sokol AI, Sokol ER, Kudish BI, Gutman RE, Peterson JL, Shott S. Vaginal mesh for prolapse: a randomized controlled trial. Obstet Gynecol. 2010 Aug;116(2 Pt 1):293-303. doi: 10.1097/AOG.0b013e3181e7d7f8. |
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From January 3, 2007 to August 1, 2009, 238 women were identified as eligible and 65 randomized (32 to experimental group (mesh) and 33 to control group (non-mesh)).
All patients completed 3 month followup. Study recruitment halted at median followup of 9.7 months due to pre-determined criteria of vaginal mesh exposure in 5/32 patients (15.6%) in the mesh arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | Prolift Mesh | vaginal prolapse repair with anterior or total mesh synthetic monofilament polypropylene mesh: Vaginal prolapse repair with mesh |
| FG001 | Prolapse Repair Without Mesh | vaginal prolapse repair without mesh (native tissue repair) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 3 Months |
| |||||||||||||
| 12 Months |
| |||||||||||||
| 36 Months |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Prolift Mesh | vaginal prolapse repair with anterior or total mesh synthetic monofilament polypropylene mesh: Vaginal prolapse repair with mesh |
| BG001 | Prolapse Repair Without Mesh |
| 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 | Number of Participants With Anatomic Cure at 3 Years | 3 different measures for Anatomic cure using POPQ measurements:
Patient Satisfaction using Patient Global Impression of Improvement with response of very much better or much better | Posted | Count of Participants | Participants | 3 year |
|
3 months, 1 year, 3 years
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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 | Prolift Mesh | vaginal prolapse repair with mesh synthetic monofilament polypropylene mesh: Vaginal prolapse repair with mesh |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Surgery/reoperation for mesh exposure | Surgical and medical procedures | Systematic Assessment | Reoperation for mesh related complication, exposure |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| suture exposure | Surgical and medical procedures | Systematic Assessment | Gore-tex suture exposure |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Allie Moses, Manager, Clinical Research Systems and Recruitment Center | MedStar Health Research Institute | 301-560-7353 | Allison.E.Moses@MedStar.net |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| D014596 | Uterine Prolapse |
| D052858 | Cystocele |
| D020047 | Rectocele |
| D011391 | Prolapse |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
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| NOT COMPLETED |
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| NOT COMPLETED |
|
|
vaginal prolapse repair without mesh (native tissue repair)
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Postmenopausal | Count of Participants | Participants |
|
| Parity | Median | Inter-Quartile Range | number deliveries |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| POP-Q stage | Stages of POP-Q system measurement: 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 1 cm or less proximal or distal to the hymenal plane Stage 3 the most distal portion of the prolapse protrudes more than 1 cm below the hymen but protrudes no farther than 2 cm less than the total vaginal length (for example., not all of the vagina has prolapsed) Stage 4 vaginal eversion is essentially complete | Count of Participants | Participants |
|
| married | Count of Participants | Participants |
|
| education | Count of Participants | Participants |
|
| insurance | Count of Participants | Participants |
|
| hysterectomy | Count of Participants | Participants |
|
| prior prolapse surgery | Count of Participants | Participants |
|
| prior incontinence surgery | Count of Participants | Participants |
|
| Prolapse Repair Without Mesh |
vaginal prolapse repair without mesh synthetic monofilament polypropylene mesh: Vaginal prolapse repair with mesh |
|
|
|
| Secondary | Bothersome Dyspareunia | Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire question 5 response of usually or always and tracked resolution, persistence, de novo dyspareunia | Posted | Count of Participants | Participants | 3 year |
|
|
|
| 1 |
| 32 |
| 5 |
| 32 |
| 0 |
| 32 |
| EG001 | Prolapse Repair Without Mesh | vaginal prolapse repair without mesh synthetic monofilament polypropylene mesh: Vaginal prolapse repair with mesh | 2 | 33 | 0 | 33 | 5 | 33 |
|
|
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| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006547 | Hernia |
| de novo dyspareunia |
|