← Back to Search

Procedure

HUSLS vs R-SCP for Pelvic Organ Prolapse

N/A
Waitlist Available
Led By Sam Siddighi
Research Sponsored by Loma Linda University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Symptomatic pelvic organ prolapse
18 Years of age or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 month post operative
Awards & highlights

Study Summary

This trial will compare two surgical treatments for pelvic organ prolapse: R-SCP, a new technique, and HUSLS, the current standard.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include discomfort at the surgery site, bleeding, infection risk from surgery or mesh used in procedures. There could also be specific complications related to each surgical method that will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I feel a bulge or pressure in my pelvic area.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 month post operative
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month post operative for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pelvic Organ Prolapse Quantification (pop-q) to asses change post operatively
Secondary outcome measures
questionnaires PFDI-7
questionnaires PFIQ-20
questionnaires PGI-I
+1 more

Trial Design

2Treatment groups
Active Control
Group I: SacrocolpopexyActive Control1 Intervention
Robotic sacrocolpopexy
Group II: HUSLSActive Control1 Intervention
Vaginal high uterosacral ligament suspension

Find a Location

Who is running the clinical trial?

Loma Linda UniversityLead Sponsor
306 Previous Clinical Trials
260,846 Total Patients Enrolled
Sam SiddighiPrincipal InvestigatorLoma Linda University Health Care

Media Library

High uterosacral ligament suspension (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT02800512 — N/A
Pelvic Organ Prolapse Research Study Groups: Sacrocolpopexy, HUSLS
Pelvic Organ Prolapse Clinical Trial 2023: High uterosacral ligament suspension Highlights & Side Effects. Trial Name: NCT02800512 — N/A
High uterosacral ligament suspension (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02800512 — N/A
~6 spots leftby Dec 2024