Compare puborectalis plication versus perineorrhaphy (with or without transverse myorrhaphy) to repair vulvovaginal gaping
Official title: Randomized Study Evaluating the Treatment of Vulvovaginal Gaping by Plication of the Puborectalis Muscles Versus Perineorrhaphy ± Transverse Myorrhaphy of the Puborectalis Muscles at 12 Months.
Run by GCS Ramsay Santé pour l'Enseignement et la Recherche · NCT07245823 · Data updated 2026-11-12
This trial will test whether one of two surgical repairs better fixes vaginal laxity and improves sexual comfort in sexually active women with prolapse and vulvovaginal gaping.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | Women only |
| Enrollment | 100 (estimated) |
| Sponsor | GCS Ramsay Santé pour l'Enseignement et la Recherche Academic / other |
| Locations | 1 site (Dijon) |
| Status | Recruiting |
| Started | November 20, 2025 |
| Main results expected | April 20, 2029 |
| Study ends | April 25, 2029 |
| Registry record updated | November 24, 2025 |
| Trial ID | NCT07245823 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Sexually active women aged 18–80 with symptomatic vulvovaginal incompetence and a resting genital hiatus ≥4 cm who are candidates for surgical repair are ideal candidates.
✕Probably not a fit
Women who are not sexually active or planning sexual activity, those with chronic perineal pain, anal sphincter injury requiring different surgery, contraindications to anesthesia, or a genital hiatus <4 cm are unlikely to benefit from this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized interventional trial compares two surgical approaches for anatomical reconstruction of vulvovaginal gaping: plication of the puborectalis muscle versus perineorrhaphy with or without transverse myorrhaphy, with outcomes measured at 12 months. Participants undergo baseline and follow-up pelvic exams (POP-Q), MRI, and standardized patient questionnaires addressing sexual function and symptoms. Eligible women are aged 18–80, sexually active, have a genital hiatus ≥4 cm, and are candidates for corrective surgery. The trial is conducted at Hôpital privé Dijon Bourgogne under the sponsorship of Ramsay Générale de Santé.
Why it matters
Potential benefit: If successful, one surgical method could provide better restoration of introital anatomy, reduce vaginal laxity, and improve sexual comfort and self-image.
How similar studies have gone: Perineoplasty and related pelvic-floor repairs have shown symptomatic improvements in prior reports, but direct randomized comparisons of puborectalis plication versus perineorrhaphy are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Hopital privé Dijon Bourgogne
Dijon, France Recruiting
Study contacts
- Study coordinator: Jean-François Oudet, M.
- Email: jf.oudet@ecten.eu
- Phone: 0033683346567
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.