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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 belowSelect...
I feel a bulge or pressure in my pelvic area.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 month post operative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 month post operative
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 moreTrial 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
Eligibility Criteria:
This trial includes the following eligibility 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 feel a bulge or pressure in my pelvic area.I do not have dementia and can complete questionnaires.You live more than 2 hours away from LLUH.The medical doctor's opinion is needed.My caregiver says I can't complete tasks by myself.I have had multiple strokes or another neurological condition.My surgery did not include a high uterosacral ligament suspension.I am against using mesh for personal reasons, have had issues with it before, or am pregnant/planning to be.I do not have a car or any way to get to places.I can't attend follow-up visits because I have no way to get there.I am 18 years old or older.I can attend all required study visits.I have been diagnosed with Alzheimer's Disease.You have certain birth defects or medical conditions related to the bladder or reproductive system.
Research Study Groups:
This trial has the following groups:- Group 1: Sacrocolpopexy
- Group 2: HUSLS
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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