Status:
COMPLETED
Study of Uterine Prolapse Procedures - Randomized Trial
Lead Sponsor:
NICHD Pelvic Floor Disorders Network
Collaborating Sponsors:
Boston Scientific Corporation
Conditions:
Uterovaginal Prolapse
Eligibility:
FEMALE
21+ years
Phase:
NA
Brief Summary
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 hysteropex...
Detailed Description
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 onl...
Eligibility Criteria
Inclusion
- Women aged 21 or older who have completed child -bearing
- Prolapse beyond the hymen (defined as Ba, Bp, or C \> 0 cm)
- Uterine descent into at least the lower half of the vagina (defined as point C\> -TVL/2) )
- Bothersome bulge symptoms as indicated on question 3 of the PFDI-20 form relating to 'sensation of bulging' or 'something falling out'
- Desires vaginal surgical treatment for uterovaginal prolapse
- Available for up to 60 month follow-up
- Amenorrhea for the past 12 months from either menopause or endometrial ablation
- Not pregnant, not at risk for pregnancy or agree to contraception if at risk for pregnancy (only applicable to the rare endometrial ablation patient)
- Eligible for no cervical cancer screening for at least 3 years
Exclusion
- Previous synthetic material (placed vaginally or abdominally) to augment POP repair
- Known previous uterosacral or sacrospinous uterine suspension
- Known adverse reaction to synthetic mesh or biological grafts; these complications include but are not limited to erosion, fistula, or abscess
- Chronic pelvic pain
- Pelvic radiation
- Cervical elongation- defined as an expectation that the C point would be Stage 2 or greater postoperatively if a hysteropexy was performed. (Note: cervical shortening or trachelectomy is not an allowed intraoperative procedure within the hysteropexy treatment group).
- Women at increased risk of cervical dysplasia requiring cervical cancer screening more often than every 3 years (e.g. HIV+ status, immunosuppression because of transplant related medications, Diethylstilbestrol (DES) exposure in utero, or previous treatment for cervical intraepithelial neoplasia (CIN)2, CIN3, or cancer)
- Uterine abnormalities (symptomatic uterine fibroids, polyps, endometrial hyperplasia, endometrial cancer, or any uterine disease that precluded prolapse repair with uterine preservation in the opinion of the surgeon
- Indication for ovarian removal (adnexal mass, BRCA 1/2 positivity, family history of ovarian cancer)
- Current condition of amenorrhea caused by exogenous sex steroids or hypothalamic conditions.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 7 2025
Estimated Enrollment :
183 Patients enrolled
Trial Details
Trial ID
NCT01802281
Start Date
April 1 2013
End Date
March 7 2025
Last Update
August 26 2025
Active Locations (8)
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1
University of Alabama at Birmingham, Department of Obstetrics and Gynecology
Birmingham, Alabama, United States, 35249
2
University of California at San Diego, UCSD Women's Pelvic Medicine Center
La Jolla, California, United States, 92037-0974
3
University of New Mexico Health Sciences Center, Department of Obstetrics and Gynecology
Albuquerque, New Mexico, United States, 87131
4
Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery
Durham, North Carolina, United States, 27707