Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
FEMALE
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)

Led by Ramsay Générale de Santé · Updated on 2025-11-24

100

Participants Needed

1

Research Sites

178 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

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. (HERA)

Who Can Participate

Age: 18Years - 80Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patient between 18 and 80 years old
  • Genital hiatus at rest of 4 cm or more measured by POP-Q
  • Sexually active woman without pain during penetration or woman who stopped sexual activity due to vulvovaginal incompetence without pain
  • Diagnosed with prolapse
  • Candidate for surgery to reconstruct vulvovaginal incompetence
  • Affiliated with a social security scheme or beneficiary according to Article L.1124-1 of the Public Health Code
  • Provided free, informed, and signed consent
Not Eligible

You will not qualify if you...

  • Genital hiatus at rest less than 4 cm by POP-Q classification
  • Women not sexually active and not planning to become sexually active
  • Chronic perineal pain syndrome
  • Anal sphincter injury requiring sphincter repair
  • Cognitive or language impairments preventing completion of study questionnaires
  • Contraindications to surgery or anesthesia
  • Adults under guardianship, curatorship, legal protection, deprived of liberty by judicial or administrative decision, or hospitalized without consent
  • Pregnant, breastfeeding, or recently gave birth
  • Planning to become pregnant during the study period
  • Immediate postpartum

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hopital privé Dijon Bourgogne

Dijon, France, 21000

Actively Recruiting

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Research Team

J

Jean-François Oudet, M.

CONTACT

M

Marie-Hélène Barba

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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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) | DecenTrialz