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Mesh vs. laparoscopy: which surgery fixes bladder prolapse better?

NCT ID NCT01637441

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study compared two surgical techniques for repairing a cystocele, a type of pelvic organ prolapse where the bladder bulges into the vagina. The two methods were laparoscopic sacropexy (keyhole surgery using a mesh) and vaginal mesh surgery. The trial enrolled 262 women and looked at complications and outcomes one year after surgery. The goal was to see which approach is safer and more effective.

What this could mean

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

Active substance
synthetic non-absorbable mesh
What this could lead to
If successful, this could help doctors choose the safer and more effective surgical approach for repairing a cystocele, improving women's quality of life.
What could go wrong
This is a completed study comparing two established procedures, so no major breakthroughs are expected. Results may show one technique is better for certain patients, but individual outcomes vary.

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

262 people

The number who actually took part.

Start date

Sep 2012

Finished

Nov 2015

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

45 to 75 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: * Cystocele superior or equal to stage II of the international classification POP-Q, isolated or associated with other elements of prolapse. * Patient must have provided written informed consent form prior to enrolment * Patient must be insured Exclusion Criteria: * Previous of surgery for prolapse * Unfavourable conditions to one or other of the 2 evaluated procedure * Pelvic malignancy in the course of evolution * Contraindication to the use of mesh * Women not reading French * Patients haven't have a social insurance * Pregnancy or desire for future pregnancy * To be under guardianship or deprived of liberty * Simultaneous participation in another biomedical research

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Conditions

The condition(s) this trial relates to.

Cystocele pelvic organ prolapse

As listed by the trial registrant

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

Cystocele

Contacts and locations

Locations

  • CH La Rochelle Service de Gynécologie Obstétrique

    La Rochelle, 17019, France

  • CHI Poissy-St-Germain / Service de gynécologie

    Poissy, 78303, France

  • CHRU de Lille - Service de Gynécologie médico chirurgicale

    Lille, 59037, France

  • CHU Estaing

    Clermont-Ferrand, 63003, France

  • CHU de Nîmes

    Nîmes, 30029, France

  • CHU de Poitiers

    Poitiers, 86000, France

  • GCS Flandre Maritime

    Grande-Synthe, 59760, France

  • Groupe Hospitalier Diaconesses Croix St-Simon

    Paris, 75571, France

  • Hôpital Antoine Béclère

    Clamart, 92140, France

  • Hôpital BICETRE / Service de Gynécologie Obstétrique

    Le Kremlin-Bicêtre, 94275, France

  • Hôpital de Hautepierre

    Strasbourg, 67000, France

  • Sébatien BLANC

    Annecy, 74374, France

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