Study of Uterine Prolapse Procedures - Randomized Trial (NCT01802281) | Clinical Trial Compass
CompletedNot Applicable
Study of Uterine Prolapse Procedures - Randomized Trial
United States183 participantsStarted 2013-04-01
Plain-language 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 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.
Who can participate
Age range21 Years
SexFEMALE
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Inclusion criteria
✓. 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)
Exclusion criteria
✕. 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