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Mesh study aims to fix pelvic organ prolapse

NCT ID NCT01559168

Disease control Sponsor: Centre Hospitalier Universitaire de Nīmes 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a special mesh (Uphold LITE) to treat uterine prolapse, a condition where the uterus drops into the vagina. 121 women received the mesh and were followed for 12 months. The goal was to see if the mesh could restore normal anatomy and relieve symptoms without needing more surgery.

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

121 people

The number who actually took part.

Start date

Oct 2012

Finished

Oct 2016

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

50 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: * The patient must have given his/her informed and signed consent * The patient must be insured or beneficiary of a health insurance plan * The patient is available for 12 months of follow-up * Patients with symptoms and altered quality of life in relation to uterine or post-hysterectomy vault prolapse * Patients who are receiving the UpholdTM LITE mesh Kit * Female patients \>= years who have no desire of future pregnancy * Diagnosed with pelvic organ prolapse and \>= ICS POP-Q Stage 2 Symptomatic Prolapse apical compartment (uterine or vault), associated with ICS POP-Q Stage 2 or 3 Symptomatic Prolapse anterior compartment (point Ba \>= -1 * Patients willing to complete quality of life questionnaire at baseline (pre-procedure) and at 6 weeks, 6 and 12 months post-procedure Exclusion Criteria: * The patient is participating in another study * The patient is in an exclusion period determined by a previous study * The patient is under judicial protection, under tutorship or curatorship * The patient refuses to sign the consent * It is impossible to correctly inform the patient * The patient is pregnant, parturient, or breastfeeding * Patients who are not receiving the UpHoldTM LITE mesh Kit * Patients \< 50 years * Patients qho, according to the clinical judgment of the investigator, are not suitable for this study * Patients who are considering future pregnancies * Patients whose pelvic organ prolapse is a \<= 1 ICS Stage * Patients requiring Posterior Graft procedure * Patients with known or suspected hypersensitivity to polypropylene * Patients with any pathology which ould compromise implant placement * Patients with any pathology which ould compromise implant placement as mentioned in the device instruction manual * Patients with any pathology that would limit blood supply and compromise healing * Patients with blood coagulation disorder (associated current level coagulation) * Patients with autoimmune connective tissue disease * Patients with upper urinary tract obstruction and renal insufficiency * Patients with local or systemic infection

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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.

Pelvic organ prolapse

Contacts and locations

Locations

  • APHM - Hôpital de la Conception

    Marseille, 13385, France

  • CH Camille Guérin

    Châtellerault, 86106, France

  • CH Louis Giorgi

    Orange, 84106, France

  • CH de Dunkerque

    Dunkirk, 59385, France

  • CH de Gonesse

    Gonesse, 95500, France

  • CHRU de Lille - Hôpital Jeanne de Flandre

    Lille, 59037, France

  • CHRU de Lyon - Hôpital de la Croix Rousse

    Lyon, 69317, France

  • CHU de Clermont Ferrand - Hôpital Estaing

    Clermont-Ferrand, 63003, France

  • CHU de Montpellier - Hôpital Lapeyronie

    Montpellier, 34295, France

  • CHU de Nîmes - Hôpital Universitaire Carémeau

    Nîmes, 30029, France

  • CHU de Poitiers

    Poitiers, 86021, France

  • Clinique Beau Soleil

    Montpellier, 34070, France

  • Hôpital Foch

    Suresnes, 92150, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.