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Mesh showdown: which surgery fixes prolapse best?

NCT ID NCT04478747

Disease control Sponsor: Helsinki University Central Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study compares two types of mesh surgery for women with pelvic organ prolapse after a hysterectomy. One surgery uses a mesh placed through the vagina, the other uses a mesh placed through small cuts in the belly (laparoscopic). The main goal is to see which surgery works better at stopping the feeling of a vaginal bulge one year later. The study also looks at safety, pain, and costs.

What this could mean

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

Active substance
surgical mesh (BSC mesh for transvaginal; EndoGYNious mesh for laparoscopic colposacropexy)
What this could lead to
If successful, this could show which mesh surgery is more effective and safer for treating apical prolapse, helping guide future treatment choices.
What could go wrong
This is a single-center trial with 318 participants, so results may not apply to all women. Mesh surgeries carry risks like pain, erosion, and complications.

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

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

About 318 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2020

Expected to finish

Dec 2032

An estimate. End dates often move.

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.

Ages

18 to 99 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Age over 18 years and capability to understand the study protocol either in Finnish or Swedish. * Objectively diagnosed symptomatic apical prolapse (leading apical prolapse (points C/D) ≥ -2) and a history of previous POP operation including hysterectomy. * No need for any other concomitant operations except colporrhaphies and possible prophylactic salpingo-oophorectomy in CSP groups Exclusion Criteria: * A history of serious or prolonged pain after any operation or current or previous prolonged (over 6 months) pain of any reason. * BMI over 40 * Regular use of systemic corticosteroid medication. * Incapability to understand the study protocol.

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Conditions

The condition(s) this trial relates to.

pelvic organ prolapse

As listed by the trial registrant

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

Prolapse, vaginal vault

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Helsinki Naistenklinikka

    RECRUITING

    Helsinki, Finland