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) (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.

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.

Study Overview

• Status: Recruiting
• Conditions: Vulvovaginal Disease; Prolapse Genital
• Intervention / Treatment: Procedure: Anatomical reconstruction of the vulvovaginal gape; Other: Questionnaires; Radiation: MRI

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie-Hélène Barba; Email: mh.barba@ecten.eu
• Study Contact Backup: Name: Jean-François Oudet, M.; Phone Number: 0033683346567; Email: jf.oudet@ecten.eu

Study Locations

• France
  • Dijon, France, 21000
    • Recruiting
    • Hôpital privé Dijon Bourgogne
    • Contact: Aurélie Guyomard, Dr; Phone Number: 0033676382990; Email: docteurguyomard@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sagittal plication of the puborectal muscles reconstruction; Anatomical reconstruction of the vulvovaginal gape by sagittal plication of the puborectal muscles	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
Active Comparator: Perineorrhaphy ± transverse myorrhaphy of the puborectal muscles reconstruction; Anatomical reconstruction of the vulvovaginal gape by perineorrhaphy ± transverse myorrhaphy of the puborectal muscles	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of anatomical reconstruction of vulvovaginal gaping	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)	12 months

Collaborators and Investigators

• Sponsor: Ramsay Générale de Santé

Study record dates

Study Major Dates

• Study Start (Estimated): November 20, 2025
• Primary Completion (Estimated): April 20, 2029
• Study Completion (Estimated): April 25, 2029

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 24, 2025

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: 2024-A01362-45

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No