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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Anatomical reconstruction of the vulvovaginal gape, Questionnaires, MRI.
- Who it may be relevant to
- Registry conditions: Prolapse Genital, Vulvovaginal Disease. Basic parameters: 18 years — 80 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Overview
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.
Interventions
- 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
Primary outcome measures
- Effectiveness of anatomical reconstruction of vulvovaginal gaping [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Hopital privé Dijon Bourgogne — Dijon
Identifiers
NCT: NCT07245823 · 2024-A01362-45