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Can a biological mesh improve pelvic floor surgery?

NCT ID NCT06245577

Symptom relief Sponsor: Evangelisches Klinikum Köln Weyertal gGmbH 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Last updated Sep 11, 2026

Summary

This pilot study compares two types of surgical mesh, biological and synthetic, used during a combined operation for pelvic organ prolapse and rectal prolapse. Thirty participants with obstructed defecation syndrome and pelvic organ prolapse undergo laparoscopic mesh sacropexy plus resection rectopexy. Researchers track surgical complications over 12 months and measure changes in bowel symptoms using the Altomare score. The goal is to see whether the biological mesh is safe and effective enough to test in a larger multicentre trial.

What this could mean

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

Active substance
biological mesh versus synthetic mesh used in laparoscopic pelvic floor reconstruction
What this could lead to
If the biological mesh proves safer or more effective, it could offer a better option for people needing combined pelvic and rectal prolapse repair.
What could go wrong
This is a small pilot study with 30 participants, so results may not hold in larger groups. Mesh surgery carries risks of infection, pain, or recurrence, and the biological mesh may not outperform the standard synthetic type.

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

30 people

The number who actually took part.

Started

Jan 2024

Finished

Dec 2025

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 80 years

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: * clinical diagnosis of obstructed defection syndrome * clinical diagnosis of pelvic organ prolapse pelvic organ prolapse * must be suitable for surgery Exclusion Criteria: * allergy to the components of the mesh * pregnancy

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Conditions

The condition(s) this trial relates to.

intestinal obstruction pelvic organ prolapse rectal prolapse

As listed by the trial registrant

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

Intestinal obstruction Pelvic organ prolapse Rectal prolapse

Contacts and locations

Locations

  • Evangelisches Klinikum Koeln Weyertal

    Cologne, North Rhine-Westphalia, 50931, Germany

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