Complications; Perineal Repair Clinical Trial
— SEX-RPCOfficial title:
Retrospective Evaluation of Functional and Sexological Results of Surgical Perineal Repair
| Verified date | September 2022 |
| Source | Centre Hospitalier Universitaire de Nimes |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 55 |
| Est. completion date | December 31, 2021 |
| Est. primary completion date | December 31, 2021 |
| Accepts healthy volunteers | |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Centre Hospitalier Universitaire | Nîmes | Gard |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire de Nimes |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To evaluate the sexological results of surgical perineal repair. | 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) | Day 30 |