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New surgery may restore vaginal comfort and confidence

NCT ID NCT07245823

Disease control Sponsor: Ramsay Générale de Santé 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests two surgical techniques to fix vulvovaginal gaping, a condition that can cause discomfort and sexual problems. One hundred women with genital prolapse will be randomly assigned to either a newer muscle-plication surgery or a standard repair. The goal is to see which method better restores anatomy and improves sexual quality of life after one year.

What this could mean

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

Active substance
surgical procedure (puborectalis muscle plication or perineorrhaphy)
What this could lead to
If successful, this could offer a better surgical option for women with vulvovaginal gaping, improving sexual comfort and self-image.
What could go wrong
This is a small, early-stage trial with only 100 participants. Surgery carries risks like pain, infection, or scarring, and results may not apply to all women.

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 100 people

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

Expected to start

Nov 2025

An estimate. Start dates often move.

Expected to finish

Apr 2029

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 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: * Female patient between 18 and 80 years-old. * Genital hiatus at rest ≥ 4 cm by POP-Q * Sexually active woman without pain (never/rarely scored) during penetration and who has stopped sexual activity due to vulvovaginal incompetence without pain (never/rarely scored) during penetration * Prolapse * Candidate for surgery for anatomical reconstruction of the vulvovaginal incompetence * Patient affiliated with a social security scheme or beneficiary of such a scheme, according to Article L.1124-1 of the Public Health Code * Free, informed and signed consent Exclusion Criteria: * Resting GH \< 4 cm (POP-Q classification) * Women not sexually active and not planning to become sexually active * Chronic perineal pain syndrome * Anal sphincter injury with concomitant indication for sphincterorrhaphy * Cognitive or language impairment of the patient unable to complete the study questionnaires * Contraindications to surgery or anesthesia * Adult under guardianship, curatorship, or other legal protection, deprived of liberty by judicial or administrative decision, hospitalized without consent * Pregnant, breastfeeding, or parturient woman * Patient planning to become pregnant during the study period * Immediate postpartum

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Conditions

The condition(s) this trial relates to.

pelvic organ prolapse prolapse of female genital organ vulvar disease

As listed by the trial registrant

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

Prolapse genital Vulvovaginal disease

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

  • Hopital privé Dijon Bourgogne

    RECRUITING

    Dijon, 21000, France

More trials for these conditions

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