Study of Uterine Prolapse Procedures - Randomized Trial
Completed · Not applicable
Conditions studied: Uterovaginal Prolapse
In brief
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.
Key facts
- Study ID
- NCT01802281
- Run by
- NICHD Pelvic Floor Disorders Network
- People needed
- 183
- Starts
- 2013-04-01
- Expected to finish
- 2025-03-07
- Last updated by the study team
- 2025-08-26
Who can join
Age: 21 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- University of Alabama at Birmingham, Department of Obstetrics and Gynecology — Birmingham, Alabama, United States
- University of California at San Diego, UCSD Women's Pelvic Medicine Center — La Jolla, California, United States
- University of New Mexico Health Sciences Center, Department of Obstetrics and Gynecology — Albuquerque, New Mexico, United States
- Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery — Durham, North Carolina, United States
- Cleveland Clinic, Department OB/GYN — Cleveland, Ohio, United States
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
- Magee-Women's Hospital, Department of Obstetrics and Gynecology — Pittsburgh, Pennsylvania, United States
- Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery — Providence, Rhode Island, United States
Full record on ClinicalTrials.gov
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