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Can a simple stitch reduce repeat prolapse surgery?

NCT ID NCT07006129

Disease control Sponsor: Lund University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

Researchers are studying whether adding a perineorrhaphy, a repair of the perineum, during vaginal prolapse surgery lowers the need for repeat surgery and eases symptoms. The study uses Swedish registry data to compare women who had the extra procedure with those who did not. It focuses on women having native tissue repair without hysterectomy. The main outcomes are reoperation rates over five years and patient-reported bulge symptoms at one year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Perineorrhaphy, a surgical procedure to repair the perineum, added during vaginal prolapse surgery
What this could lead to
If adding perineorrhaphy helps, it could lower the chance of repeat prolapse surgery and ease bulge symptoms for many women.
What could go wrong
This is an observational study, not a randomized trial, so results may be influenced by patient differences. The benefit may be small or limited to certain women.

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.

Participants

40,646 people

The number who actually took part.

Started

Jan 2007

Finished

Dec 2022

Lead sponsor

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.

Who is studied

Patients with their primary vaginal pelvic organ prolapse surgery registered in the Swedish National Quality Register of Gynaecological Surgery (GynOp).

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Pelvic organ prolapse surgery with vaginal native tissue repair without concomitant hysterectomy. Exclusion Criteria: * Primary surgery with colpocleisis, use of mesh, laparoscopic or abdominal surgery, concomitant incontinence surgery (eg transvaginal tape). * Previous hysterectomy * Previous pelvic organ prolapse surgery

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Conditions

The condition(s) this trial relates to.

Cystocele pelvic organ prolapse Rectocele

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pelvic organ prolapse (POP) Pelvic organ prolapse vaginal surgery

Contacts and locations

Locations

  • Lund University

    Malmö, Sweden

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