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Study identifier: NCT07245823 Synced from ClinicalTrials.gov · July 28, 2026
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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)

Condition: Prolapse Genital · Vulvovaginal Disease  ·  Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

PhaseNA
Planned participants100
Who can joinFemale, 18 Years to 80 Years
Healthy volunteersNo

About this study

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 …

This description comes directly from the study's public registry record.

Talk to the study team

Jean-François Oudet, M.  ·  0033683346567  ·  jf.oudet@ecten.eu

Marie-Hélène Barba  ·  mh.barba@ecten.eu

Always discuss trial participation with your own doctor first.

Locations (1)

Hopital privé Dijon BourgogneDijon, FranceRecruiting

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Source record: clinicaltrials.gov/study/NCT07245823