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临床试验/NCT07245823
NCT07245823招募中不适用

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.

Ramsay Générale de Santé2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年11月20日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
Effectiveness of anatomical reconstruction of vulvovaginal gaping

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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
  • 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

排除标准

  • 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

结局指标

主要结局

Effectiveness of anatomical reconstruction of vulvovaginal gaping

时间窗: 12 months

The effectiveness of anatomical reconstruction of the vulvovaginal gap will be assessed at 12 months using a composite criterion. The reconstruction will be considered successful if the following three criteria are met: * Resting GH \< 4 cm, * AND PGI-I "overall condition" improved or greatly improved, * AND pain during intercourse rated "never or rarely" (question 6 of the PPSSQ)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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