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临床试验/NCT04835311
NCT04835311已完成不适用

Retrospective Evaluation of Functional and Sexological Results of Surgical Perineal Repair

Centre Hospitalier Universitaire de Nīmes1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2021年3月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
55
试验地点
1
主要终点
To evaluate the sexological results of surgical perineal repair.

研究概览

简要总结

Vaginal laxity" syndrome is an increasingly frequent reason for gynecological consultations. Patients complain above all of a sensation of excessive vaginal looseness. This syndrome can be isolated or associated with genital prolapse. Women with vaginal laxity may experience sexual dysfunction manifested by hypersensitivity during penetration and vaginal gas, resulting in decreased libido. Among urogynecology patients, vaginal laxity has been reported in up to 24% of cases, with a mean discomfort of 5.7 (on a scale of 0 to 10). Vaginal laxity is more common in younger women who have given birth vaginally. Gynecologic examination usually finds widening of the urogenital hiatus during the Valsalva maneuver, suggesting that vaginal laxity may be a manifestation of hyperdistensibility or disinsertion of the levator ani muscles. Campbell et al. noted that vaginal laxity was reported by 38% of 22621 women attending a urogynecology clinic and was associated with vaginal parity, prolapse symptoms, stress, and urinary urgency incontinence, reduced sensation on the ePAQ-PF questionnaire. In an IUGA survey of member physicians, 83% of respondents felt that vaginal laxity was underreported by patients.

The most common clinical definition of vaginal laxity is a urinary meatus to vulvar fork distance (GH measure of the POP-Q classification) > or = 4cm.

The first-line treatment for vaginal laxity is perineal rehabilitation. If this fails, surgical perineal repair, combining posterior perineorrhaphy and myorrhaphy of the pubo-rectal bundles of the levator ani muscles, can be performed with the aim of narrowing the introital vaginal caliber and improving the symptoms of laxity. This procedure is poorly evaluated in the literature.

The purpose of this study is to evaluate the functional and sexological results of surgical perineal repair.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • women who underwent surgical perineal repair (CCAM codes JMMA002 and/or HKCA005) between July 2012 and September 2020 at Nîmes University Hospital.
  • Adult patient (≥18 years old)
  • Enrolled in a social security plan
  • Patient does not object to the study

排除标准

  • Prolapse surgery without perineal repair
  • Perineal repair without levator myorrhaphy
  • Patient who objected to the use of their data.
  • Pregnancy since the operation
  • Persons under court protection,
  • Person participating in another research study with an ongoing exclusion period,
  • Severely impaired physical and/or psychological health that, in the opinion of the investigator, may affect the participant's compliance with the study

结局指标

主要结局

To evaluate the sexological results of surgical perineal repair.

时间窗: Day 30

Validated questionnaire (Pelvi-Perineal Surgery Sexuality Questionnaire). Sexual health = score minimum 2 / maximum 29 (29 = very good sexual health) Discomfort and pain = score minimum 0 / maximum 15 (15 = important discomfort or pain)

次要结局

未报告次要终点

研究者

发起方
Centre Hospitalier Universitaire de Nīmes
申办方类型
Other
责任方
Sponsor

研究点 (1)

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