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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)

RecruitingNAAges 18 Years - 80 YearsFemaleGCS Ramsay Santé pour l'Enseignement et la Recher…
NCT07245823 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 sym

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📋 Eligibility rules (as published)
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
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What it tests

  • Anatomical reconstruction of the vulvovaginal gape
  • Questionnaires
  • MRI
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Where

1 site
Hopital privé Dijon Bourgogne
Dijon, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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