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)
Recruiting
N/A
Interventional Study
Prolapse Genital
Vulvovaginal Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 80
- Sex
- Female
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 100 (estimated)
- Sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche · Other
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About This Trial
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 verbali…
Trial Locations
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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 pen…
Contacts