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Prophylactic Surgery for Prolapse Recurrence
N/A
Recruiting
Led By Julia Geynisman-Tan, M.D
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Symptomatic prolapse (stage II or greater) undergoing minimally-invasive sacrocolpopexy with Restorelle ultra lightweight mesh
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial will test if it's beneficial for surgeons to do a prophylactic posterior colpoperineorrhaphy (a procedure to fix a prolapse) in addition to a mesh-augmented apical prolapse repair.
Who is the study for?
This trial is for women over 18 with symptomatic prolapse (stage II or greater) who are undergoing a specific minimally-invasive surgery using Restorelle mesh and have a genital opening of at least 4cm when straining. Participants must speak English or Spanish. Women who are pregnant, had previous prolapse surgery, suffer from inflammatory bowel disease, have certain pelvic floor muscle conditions, or experience pain during intercourse cannot join.Check my eligibility
What is being tested?
The REDUCE Trial is testing if adding an extra surgical step called prophylactic posterior colpoperineorrhaphy to the standard mesh-augmented apical prolapse repair can prevent the recurrence of uterine prolapse in patients.See study design
What are the potential side effects?
Potential side effects may include discomfort at the surgical site, infection risk, bleeding complications, and possible changes in sexual function due to the additional posterior colpoperineorrhaphy procedure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a noticeable pelvic organ prolapse and will undergo a specific minimally-invasive surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
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) System
Secondary outcome measures
Defecatory Dysfunction
Dyspareunia
Surgical and Perioperative Events: Blood Loss
+3 moreTrial Design
2Treatment groups
Active Control
Group I: Sacralcolpopexy with posterior colpoperineorrhaphyActive Control1 Intervention
Group II: Sacralcolpopexy without posterior colpoperineorrhaphyActive Control1 Intervention
Find a Location
Who is running the clinical trial?
University of KansasOTHER
147 Previous Clinical Trials
325,661 Total Patients Enrolled
Northwestern UniversityLead Sponsor
1,586 Previous Clinical Trials
917,051 Total Patients Enrolled
The Institute of Pelvic Medicine & Reconstructive Surgery, Allentown, PennsylvaniaOTHER
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a noticeable pelvic organ prolapse and will undergo a specific minimally-invasive surgery.I speak English or Spanish.You are currently pregnant.I have inflammatory bowel disease (Crohn's or Ulcerative Colitis).I have had surgery for organ prolapse before.I am planning to have a Burch procedure.I experience pain during sexual intercourse.I am a woman aged 18 or older.
Research Study Groups:
This trial has the following groups:- Group 1: Sacralcolpopexy with posterior colpoperineorrhaphy
- Group 2: Sacralcolpopexy without posterior colpoperineorrhaphy
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are taking part in this research endeavor?
"Affirmative. According to public records on clinicaltrials.gov, this scientific investigation is currently recruiting participants and was established on November 23rd 2021. The last update occurred December 8th 2021 and the trial aims to enrol 200 individuals at a single site."
Answered by AI
Are there any remaining slots for participants in this clinical trial?
"Clinicaltrials.gov asserts that this clinical trial is currently recruiting participants, with the initial advert being posted on November 23rd 2021 and the most recent update occurring December 8th 2021."
Answered by AI
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