NCT07245823

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. (HERA)

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Ramsay Générale de Santé · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Vulvovaginal incompetence is generally associated with prolapse and contributes to the pathogenesis of the latter. The perineum and the perineal body (PB) are structures frequently injured throughout life, leading to vesicourethral and rectoanal dysfunction, which are the main focus of study. Other symptoms, such as periorificial dyspareunia and vulvovaginal incompetence, appear to be less verbalized by women. The resulting sexual discomfort is linked, on the one hand, to physical anatomical trauma, with, in some cases, vulvovaginal incompetence contributing to a vaginal sensitivity decreased, and, on the other hand, to psychological trauma with damage to self-image. Vulvoperineoplasty is a surgical repair procedure that aims to optimally reconstruct the introital anatomy by correcting the vulvovaginal incompetence in order to restore normal anatomy, restore self-image, and treat the symptoms of vaginal laxity (feeling of a vagina that is too large and loss of vaginal sensitivity). Conventional surgical techniques for treating vulvar incompetence, such as levator myorrhaphy and perineorrhaphy, are currently being questioned because they cause functional sequelae, particularly regarding to sexual quality of life. The pubo-rectal muscle plication (PPR) technique is based on the anatomical observation of puborectalis muscle lengthening (PMR) observed on MRI scans in patients with vaginal incompetence. This technique could be an interesting alternative in the surgical treatment of vulvovaginal incompetence. The main objective of this study is to evaluate the effectiveness of anatomical reconstruction of vulvovaginal incompetence by sagittal plication of the puborectalis muscles vs. by perineorrhaphy ± transverse myorrhaphy of the puborectalis muscles at 12 months.

Conditions

• Prolapse Genital
• Vulvovaginal Disease

Interventions

Type	Name	Description
PROCEDURE	Anatomical reconstruction of the vulvovaginal gape	Anatomical reconstruction of the vulvovaginal gape with two different surgeries
OTHER	Questionnaires	Questionnaires of quality of sexual life (PPSSQ), of anal incontinence and constipation
RADIATION	MRI	MRI of the genital hiatus

Timeline

• Start date: 2025-11-20
• Primary completion: 2029-04-20
• Completion: 2029-04-25
• First posted: 2025-11-24
• Last updated: 2025-11-24

Locations

1 site across 1 country: France