NCT07245823: 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. (HERA)

Recruiting now NA Last updated 24 November 2025

What this trial tests

NA trial testing Anatomical reconstruction of the vulvovaginal gape in Prolapse Genital in 100 participants. Currently enrolling.

Timeline

20 November 2025

Primary endpoint
20 April 2029

25 April 2029

Quick facts

Lead sponsor	Ramsay Générale de Santé
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	100
Start date	20 November 2025
Primary completion	20 April 2029
Estimated completion	25 April 2029
Sites	1 location across France

Drugs / interventions tested

• Anatomical reconstruction of the vulvovaginal gape
• Questionnaires
• MRI — full drug profile →

Conditions studied

• Prolapse Genital — all drugs for Prolapse Genital →
• Vulvovaginal Disease — all drugs for Vulvovaginal Disease →

Sponsor

Ramsay Générale de Santé — full company profile →

Who can join

Adults 18 to 80, female only, with Prolapse Genital or Vulvovaginal Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.