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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 below

Select...

I feel a bulge or pressure in my pelvic area.

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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

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Loma Linda UniversityLead Sponsor

306 Previous Clinical Trials

260,876 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings for enrollment in this trial at present?

"Affirmative. Per the information posted on clinicaltrials.gov, this trial is still in search of new patients since its initiation date of December 1st 2016. It requires 112 individuals to be recruited from a single location before September 19th 2022."

Answered by AI

Who is qualified to join this scientific research endeavor?

"This clinical study is seeking 112 participants aged 18 to 100 with cystocele symptoms. To be eligible for this trial, individuals must possess the willingness and capacity to fulfil all visits associated with the experiment as well as suffer from symptomatic pelvic organ prolapse."

Answered by AI

What is the highest possible number of participants in this clinical experiment?

"Affirmative. The information on clinicaltrials.gov demonstrates that this research is actively recruiting participants; the original post was made December 1st 2016, and it has most recently been edited September 19th 2022. Altogether 112 individuals must be recruited from one medical site for this project to succeed."

Answered by AI

Is this investigation open to seniors aged 75 and above?

"The requirements for patient enrolment stipulate that individuals must fall between eighteen and one hundred years of age. Separately, 19 trials exist solely for those under 18 while 203 studies target patients above the age of 65."

Answered by AI

Recent research and studies

Journal of UrologyJournal

Long-term Results of Robotic Assisted Laparoscopic Sacrocolpopexy for the Treatment of High Grade Vaginal Vault Prolapse

Elliott, Daniel S., Amy E. Krambeck, and George K. Chow. 2006. “Long-term Results of Robotic Assisted Laparoscopic Sacrocolpopexy for the Treatment of High Grade Vaginal Vault Prolapse”. Journal of Urology. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/j.juro.2006.03.040.

American Journal of Obstetrics and GynecologyJournal

Outcomes of Transvaginal Uterosacral Ligament Suspension: Systematic Review and Metaanalysis

Margulies, Rebecca U., Mary A.M. Rogers, and Daniel M. Morgan. 2010. “Outcomes of Transvaginal Uterosacral Ligament Suspension: Systematic Review and Metaanalysis”. American Journal of Obstetrics and Gynecology. Elsevier BV. doi:10.1016/j.ajog.2009.07.052.

clinicaltrials.govStudy

SCP vs HUSLS for Pelvic Organ Prolapse Repair

2016. "SCP vs HUSLS for Pelvic Organ Prolapse Repair". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02800512.

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