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Simpler surgery for pelvic organ prolapse may be just as effective

NCT ID NCT07194343

Disease control Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a simpler version of laparoscopic surgery for pelvic organ prolapse works as well as the standard, more complex technique. 190 women with stage II-IV prolapse were randomly assigned to one of the two procedures. The goal was to see if the simpler method could achieve similar anatomical success without the extra dissection, potentially leading to fewer complications and faster recovery.

What this could mean

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

Active substance
laparoscopic colposacropexy (surgical procedure)
What this could lead to
If the simplified technique works as well as the standard one, it could offer a less invasive surgical option for women with pelvic organ prolapse, potentially reducing recovery time and complications.
What could go wrong
This is a completed study with 190 participants, so results are available but may not apply to all women. The simplified technique might not be as effective in the long term, and surgery always carries risks like infection or mesh 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.

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

190 people

The number who actually took part.

Started

Oct 2022

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.

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 with primary or recurrent apical prolapse (uterine or vaginal vault) stage II-IV according to the POP-Q classification. * Women with symptomatic POP with indication of reconstructive POP surgery. * Agreement to comply with all scheduled visits and assessments through 12 months post-surgery. * Understand and accept the study procedures and sign the informed consent. Exclusion Criteria: * History of abdominal reconstructive surgery for pelvic organ prolapse. * History of vaginal reconstructive surgery for prolapse using mesh. * Stage I prolapse according to the POP-Q classification, or asymptomatic prolapse. * Medical contraindication to general anesthesia. * Patient preference for vaginal surgical treatment. * Declines participation in the study. * Patients with disabilities or unable to understand the terms of the study.

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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 genital Prolapse uterovaginal Prolapse; female

Contacts and locations

Locations

  • Hospital Clinico Universitario Virgen de la Arrixaca

    Murcia, Spain

  • Hospital General Universitario de Valencia

    Valencia, Valencia, Spain

  • Hospital Universitari Dexeus

    Barcelona, Barcelona, Spain

  • Hospital Universitari d'Igualada

    Igualada, Barcelona, Spain

  • Hospital Universitario Infanta Sofia

    San Sebastián de los Reyes, Madrid, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Barcelona, Spain

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