New device aims to make prolapse surgery safer and less painful

NCT ID NCT05836844

Disease control Sponsor: Centre Hospitalier Universitaire de Nīmes Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a device called Anchorsure, used during surgery to fix pelvic organ prolapse (when organs like the uterus or bladder slip down). The device is meant to make the surgery faster, with less pain and fewer nerve injuries. Researchers will follow 120 women for 3 years to see if the device works well and is safe.

What this could mean

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

Active substance: Anchorsure System® (a transvaginal anchoring device for sacrospinous ligament fixation)
What this could lead to: If successful, this device could offer a safer, less painful surgical option for women with pelvic organ prolapse, reducing recovery time and complications.
What could go wrong: This is an observational study without a comparison group, so results may not prove the device is better than existing treatments. Risks include pain, nerve injury, or device-related 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.

Participants

About 120 people

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

Started

May 2023

Expected to finish

Jun 2028

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.

Who is studied

The target population is the population of adult women, undergoing a surgical treatment of The target population is the population of adult women, undergoing a surgical treatment for pelvic organ prolapse using Anchorsure System® in the participating centres: Nîmes University Hospital, Lille University Hospital, Sainte-Anne Clinic in Strasbourg, La Rochelle Hospital and Kremlin-Bicêtre Hospital.

Ages: 50 years and older
Sex: Female participants only

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: * Women with pelvic organ prolapse with leading edge at or beyond the hymen as confirmed by the pelvic organ prolapse quantification system (POP-Q), i.e. Ba ≥ -1 cm for the anterior compartment, and/or Bp ≥ -1 cm for the posterior compartment, and/or C ≥ -1 cm for the apical compartment including recurrence. * Women due for POP surgery using the Anchorsure System® for apical prolapse suspension with or without concomitant native tissue repair, with or without concomitant hysterectomy and with or without concomitant sling for stress urinary incontinence. * All women who have not indicated any objection to participating in the study. * All women who have been correctly informed. Exclusion Criteria: * Patient taking part or having taken part in a device or drug interventional study within the last three months (except for VIGI-MESH national registry). * Patients due for pelvic organ prolapse repair without apical suspension or with anything other than native tissue repair and the Anchorsure System®. * Patients with uncontrolled diabetes mellitus. * Patients with active non-controlled or chronic gynaecologic or urinary tract infection and/or local tissue necrosis. * Patients with ongoing pelvic organ cancer (e.g. uterine, ovarian, bladder, cervix …). * Patients with a history of radiotherapy in the pelvic area. * Patients on therapy with immunosuppressive or immunomodulatory treatment within the previous month. * patients under ongoing oral anticoagulant therapy. * Patients with stage 0 and 1 pelvic organ prolapse at the time of surgery * Patients with a preoperative infection contraindicating the surgery

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Conditions

The condition(s) this trial relates to.

pelvic organ prolapse Prolapse prolapse of female genital organ

As listed by the trial registrant

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

Prolapse uterovaginal Prolapse; cervix Prolapse; female

How to take part

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

The places running it

4 sites. The list below names each one and where it is.
The official record

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

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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.

New device aims to make prolapse surgery safer and less painful

What the study statuses mean