Pelvic prolapse surgery showdown: which method causes less leakage?
NCT ID NCT03200327
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compared two surgical procedures for treating pelvic organ prolapse in women aged 50-80. One method uses a vaginal approach (sacrospinofixation) and the other uses keyhole surgery through the abdomen (laparoscopic promontofixation). The goal was to see which causes less new stress urinary incontinence after surgery. The trial was terminated early and enrolled 55 participants.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could show that one surgical method reduces post-surgery urine leakage and costs less than the other, with similar effectiveness.
- What could go wrong
- The trial was terminated early and had only 55 participants, so results may be inconclusive. Surgical risks like pain or sexual discomfort remain possible.
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
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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
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55 people
The number who actually took part.
- Started
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Dec 2017
- Finished
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Mar 2021
- Lead sponsor
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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
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50 to 80 years
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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 their free and informed consent and signed the consent form * The patient must be a member or beneficiary of a health insurance plan * Patient must be available for 12 month follow-up * Patient is ≥50 and \<80 years old * Patient has pelvic prolapse stage 2 or above according to international POP-Q score, concerning the anterior and apical compartments, justifying surgical treatment * Patients not having preoperational stress urinary incontinence or having mild stress urinary incontinence not causing significant functional problems (response \<2 to question 17 of PFDI-20 questionnaire). It is possible that patients with hidden stress urinary incontinence will be recruited Exclusion Criteria: * The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study * The patient is under safeguard of justice or state guardianship * The subject refuses to sign the consent * Patient with communication issues preventing comprehension of information and administration of questionnaires * Pelvic prolapse not affect anterior and apical compartments, regardless of stage * Patient with preoperative dyspareunia (patients with mild sexual discomfort related to prolapse may be included * Patient presents with preoperative stress urinary incontinence responsible of significant functional incapacity (response ≥2 to question 17 of PFDI-20 questionnaire). * Indication for concomitant suburethral sling * Patient with previous history of surgery for stress urinary incontinence * Indication of concomitant perineorrhaphy surgery with or without myorrhaphy (in both groups). * Contra-indication for general anesthetic * Current urinary infection * Current vaginal infection
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CHU Nimes
Nîmes, 30029, France
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CHU de Lille
Lille, 59037, France
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CHU de Montpellier
Montpellier, 34295, France
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CHU de clermont-Ferrand
Clermont-Ferrand, 63003, France
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Clinique Beau-Soleil
Montpellier, 34070, France
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HFME - Hospices Civils de Lyon
Lyon, 69677, France
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