HUSLS vs R-SCP for Pelvic Organ Prolapse

Recruiting in Palo Alto (17 mi)

Overseen bySam Siddighi

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Loma Linda University

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial compares two surgeries for treating pelvic organ prolapse: one uses a robot to place a supportive mesh, and the other uses stitches to lift and secure the organs through the vagina. The goal is to find out which method is more effective.

Eligibility Criteria

This trial is for adults with symptomatic pelvic organ prolapse who can consent, attend all study visits, and have transportation within 2 hours of LLUH. It's not for those without transport or financial means, with Alzheimer's, dementia, opposition to mesh use due to beliefs or past complications, pregnancy plans during the study, chronic undetermined pelvic pain over 6 months, certain comorbidities like fibromyalgia or interstitial cystitis.

Inclusion Criteria

I feel a bulge or pressure in my pelvic area.

Signed Informed Consent

I am 18 years old or older.

+1 more

Exclusion Criteria

I have had pelvic pain for over 6 months not related to my menstrual cycle and may also have fibromyalgia, interstitial cystitis, or vulvodynia.

I do not have dementia and can complete questionnaires.

You live more than 2 hours away from LLUH.

+10 more

Participant Groups

The trial compares two surgical methods for fixing pelvic organ prolapse: Robotic Sacrocolpopexy (R-SCP) and High Uterosacral Ligament Suspension (HUSLS). The goal is to see which one works better in terms of effectiveness.

2Treatment groups

Active Control

Group I: SacrocolpopexyActive Control1 Intervention

Robotic sacrocolpopexy

Group II: HUSLSActive Control1 Intervention

Vaginal high uterosacral ligament suspension