Compare puborectalis plication versus perineorrhaphy (with or without transverse myorrhaphy) to repair vulvovaginal gaping

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.

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 80 Years
• Sex: Female
• Sponsor: Ramsay Générale de Santé (Academic / other)
• Locations: 1 site (Dijon)
• Trial ID: NCT07245823 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: Perineoplasty and related pelvic-floor repairs have shown symptomatic improvements in prior reports, but direct randomized comparisons of puborectalis plication versus perineorrhaphy are limited.

Eligibility 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 this trial is running

Dijon

• Hopital privé Dijon Bourgogne — Dijon, France (Recruiting)

Study contacts

• Study coordinator: Jean-François Oudet, M.

Conditions Prolapse Genital; Vulvovaginal Disease