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NCT Number: 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)

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.

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Key information

Conditions

Prolapse Genital Vulvovaginal Disease

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hopital privé Dijon Bourgogne

Dijon, 21000, France

Location status: Recruiting

Location contact

Aurélie Guyomard, Dr

CONTACT

[email protected]

0033676382990

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anatomical reconstruction of the vulvovaginal gape

Procedure

Anatomical reconstruction of the vulvovaginal gape with two different surgeries

questionnaires

Other

Questionnaires of quality of sexual life (PPSSQ), of anal incontinence and constipation

MRI

Radiation

MRI of the genital hiatus

Primary outcomes

  1. Effectiveness of anatomical reconstruction of vulvovaginal gaping

    Time frame: 12 months

    The effectiveness of anatomical reconstruction of the vulvovaginal gap will be assessed at 12 months using a composite criterion. The reconstruction will be considered successful if the following three criteria are met:

    • Resting GH < 4 cm,
    • AND PGI-I "overall condition" improved or greatly improved,
    • AND pain during intercourse rated "never or rarely" (question 6 of the PPSSQ)

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-François Oudet, M.

CONTACT

[email protected]

0033683346567

Marie-Hélène Barba

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Official study 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.

Acronym: HERA

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Nov 24, 2025
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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