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New mesh could improve pelvic surgery outcomes

NCT ID NCT06430931

Disease control Sponsor: Meander Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a new biological mesh (OviTex) works better than the standard synthetic mesh for women having robotic surgery for pelvic organ prolapse. About 184 participants will be followed to compare complications and symptom relief. The goal is to find a safer and more effective option for this common condition.

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 184 people

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

Started

Dec 2023

Expected to finish

Jul 2027

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 years and older

Sex

Anyone

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: * Indication for VMR or SCR set by the treating surgeon/gynecologist in accordance to the current guidelines on rectal and pelvic prolapse; * Counselled for therapeutic options and given informed consent for VMR or SCR; * Counselled for different types of mesh (OviTex or Prolene) and randomisation; * Written informed consent for randomisation, OviTex implant or Prolene; * Written informed consent for observational data collection. Exclusion Criteria: * Mentally incompetent patients (unable to fulfil questionnaires). * Allergy to ovine rumen. * A medical history of pelvic radiation therapy. * Scheduled for a redo-rectopexy. * A medical history of previously implanted pelvic floor meshes or native tissue. * Language barrier

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Conditions

The condition(s) this trial relates to.

Cystocele Hernia pelvic organ prolapse Prolapse prolapse of female genital organ rectal prolapse Rectocele Uterine Prolapse

As listed by the trial registrant

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

Colorectal disorders Cystocele Enterocele Prolapse Prolapse bladder Prolapse genital Prolapse pelvic Prolapse rectal Prolapse uterus Prolapse; cervix Rectocele

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

  • Meander Medisch Centrum

    RECRUITING

    Amersfoort, Utrecht, 3813TZ, Netherlands

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