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Own-Tissue surgery for prolapse shows promise in small study

NCT ID NCT04270188

Symptom relief Sponsor: Hospices Civils de Lyon 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at whether a surgery called anterior sacrospinofixation, which uses a woman's own tissue instead of synthetic mesh, can improve symptoms of pelvic organ prolapse. 66 women with moderate to severe prolapse were followed for 2 months after surgery. The main goal was to see how many reported feeling better on a standard symptom scale.

What this could mean

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

Active substance
anterior sacrospinofixation surgery using the patient's own tissue
What this could lead to
If successful, this could confirm that using a woman's own tissue for prolapse repair effectively eases symptoms, offering an alternative to synthetic mesh.
What could go wrong
This is a small, completed study with only 66 participants and no comparison group. Results may not apply to all women, and long-term outcomes beyond 2 months are unknown.

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

66 people

The number who actually took part.

Started

Jul 2020

Finished

Oct 2025

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

patients over 18 years old with middle and / or anterior prolapse ≥ II in the POP-Q classification and for whom an intervention by anterior sacrospinofixation by autologous tissues is planned.

Ages

18 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: * women over 18 * middle and / or anterior genital prolapse (hysterocele and / or cystocele) requiring surgical correction of stage ≥ II in the POP-Q classification * patients wanting an intervention because of the discomfort caused by the prolapse * intervention planned by anterior sacrospinofixation by autologous tissues * person having expressed his non-opposition Exclusion Criteria: * prolapse of stage \< II in the POP-Q classification, or prolapse without functional impairment * disorders involving an unacceptable risk of postoperative complications sought after questioning of the patient (blood coagulation disorders, immune system disorders, progressive diseases, etc.) * reduced mobility of the lower limbs (not allowing positioning for surgery) * pregnancy or any pregnancy plan for the duration of the study * active or latent infection * inability to understand the information given * person deprived of liberty, under guardianship.

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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

  • Hospices Civils de Lyon

    Bron, 69500, France

More trials for these conditions

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