Clinical Trials Directory

Trials / Completed

CompletedNCT04835311

Retrospective Evaluation of Functional and Sexological Results of Surgical Perineal Repair

Status
Completed
Phase
Study type
Observational
Enrollment
55 (actual)
Sponsor
Centre Hospitalier Universitaire de Nīmes · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers

Summary

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREsurgical perineal repairwomen who have undergone surgical perineal repair (codes CCAM JMMA002 and/or HKCA005)

Timeline

Start date
2021-03-26
Primary completion
2021-12-31
Completion
2021-12-31
First posted
2021-04-08
Last updated
2025-12-04

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04835311. Inclusion in this directory is not an endorsement.