Simple surgical tweak may cut prolapse return rate
NCT ID NCT04880239
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether adding a posterior repair (tightening the vaginal opening) to standard prolapse surgery helps prevent the prolapse from returning within a year. About 200 women with advanced prolapse are taking part. Half get the extra procedure, half do not, and researchers compare recurrence rates.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Posterior colpoperineorrhaphy (a surgical procedure to tighten the vaginal opening)
- What this could lead to
- If successful, this could show that adding a simple vaginal tightening step during prolapse surgery lowers the chance of prolapse coming back within a year.
- What could go wrong
- This is a relatively small, single-center trial, so results may not apply to all women. The added procedure could also increase pain or bowel issues without preventing recurrence.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2021
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Women over the age of 18 * English or Spanish speaking * Symptomatic prolapse (stage II or greater) undergoing minimally-invasive sacrocolpopexy with Restorelle ultra lightweight mesh * Preoperative genital hiatus with valsalva/strain greater than or equal to 4cm Exclusion Criteria: * Patient has had prior prolapse surgery * Patient has inflammatory bowel disease (Crohn's, Ulcerative Colitis) * Baseline dyspareunia (patient reports that they have pain with vaginal intercourse when asked as a yes/no) * Patients with a score of 7 or greater in any one muscle on the Meister Pelvic Floor Exam * Patient planning a concomitant Burch procedure * Pregnant
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Northwestern University
Chicago, Illinois, 60611, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a biological mesh improve pelvic floor surgery?
- Can targeted exercises ease mild pelvic organ prolapse without surgery?
- AI may predict which pelvic floor therapy works best
- Can a small pressure drop make prolapse surgery less painful?
- Could a simple surgical step make hysterectomies safer?