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Идёт набор NCT07245823

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)

Без фазы С лечением Prolapse Genital Vulvovaginal Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Anatomical reconstruction of the vulvovaginal gape, Questionnaires, MRI.
Кому может быть актуально
Состояния в реестре: Prolapse Genital, Vulvovaginal Disease. Базовые параметры: 18 лет — 80 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
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Официальное название

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.

Обзор

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.

Вмешательства

  • Процедура Anatomical reconstruction of the vulvovaginal gape
    Anatomical reconstruction of the vulvovaginal gape with two different surgeries
  • Другое Questionnaires
    Questionnaires of quality of sexual life (PPSSQ), of anal incontinence and constipation
  • Лучевая терапия MRI
    MRI of the genital hiatus

Первичные конечные точки

  • Effectiveness of anatomical reconstruction of vulvovaginal gaping [Срок оценки: 12 months]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Франция · 1 центр
  • Hopital privé Dijon Bourgogne — Dijon

Идентификаторы

NCT: NCT07245823 · 2024-A01362-45

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗