Surgical Treatments for Prolapse
(ASPIRe Trial)

Recruiting in Palo Alto (17 mi)

+9 other locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: NICHD Pelvic Floor Disorders Network

No Placebo Group

Trial Summary

What is the purpose of this trial?The study is a multi-center, randomized, surgical trial of women with symptomatic post-hysterectomy apical (cuff) prolapse desiring surgical treatment. This study will compare the three available surgical treatments performed in usual practice. The purpose of this study is to compare two commonly performed mesh apical repair (sacral colpopexy vs. Apical Transvaginal Mesh) and vaginal native tissue apical repairs with mesh reinforced repairs. The primary outcome is measured over time (up to 60 months) using a survival analysis approach. The investigators hypothesize that treatment failure will not differ between vaginally and abdominally placed mesh for vault vaginal prolapse, and mesh repairs (regardless of route of implantation) will be superior to native tissue apical suspension.

Eligibility Criteria

This trial is for women over 21 with symptomatic vaginal prolapse after a hysterectomy, who feel a bulge or something falling out and want surgery. They must be able to follow up for up to 5 years. Those without a cervix but with significant vaginal cuff descent are eligible.

Inclusion Criteria

I am a woman aged 21 or older.

Exclusion Criteria

Known adverse reaction to synthetic mesh or biological grafts; these complications include but are not limited to erosion, fistula, or abscess

I cannot undergo certain surgeries due to health risks.

I currently have an infection in my digestive tract.

+6 more

Participant Groups

The study compares three surgical treatments for post-hysterectomy apical prolapse: transvaginal native tissue repair, sacral colpopexy using mesh (open, robotic, or laparoscopic), and Apical Transvaginal Mesh. It aims to see if there's a difference in treatment failure between the methods over time.

3Treatment groups

Active Control

Group I: Transvaginal Native Tissue RepairActive Control1 Intervention

Transvaginal Native Tissue Repair: Sacrospinous Ligament Suspension (SSLS) and Uterosacral Ligament Suspension (USLS)

Group II: Sacral ColpopexyActive Control1 Intervention

Sacral Colpopexy performed via open, robotic, or laparoscopic procedure.

Group III: Apical Transvaginal Mesh RepairActive Control1 Intervention

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