NCT04835311 (SEX-RPC) is a clinical trial of surgical perineal repair in Complications; Perineal Repair, sponsored by Centre Hospitalier Universitaire de Nīmes.

Who is sponsoring NCT04835311?

NCT04835311 is sponsored by Centre Hospitalier Universitaire de Nīmes.

What drugs are being tested in NCT04835311?

Interventions in NCT04835311: surgical perineal repair.

What condition does NCT04835311 study?

NCT04835311 studies Complications; Perineal Repair.

Is NCT04835311 still recruiting?

NCT04835311 is currently completed. Last updated 4 December 2025.

Last reviewed 2025-12-04 · How we verify

NCT04835311: SEX-RPC

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Retrospective Evaluation of Functional and Sexological Results of Surgical Perineal Repair

Completed Last updated 4 December 2025

What this trial tests

trial testing surgical perineal repair in Complications; Perineal Repair in 55 participants. Completed in 31 December 2021.

Timeline

26 March 2021

Primary endpoint
31 December 2021

31 December 2021

Quick facts

Lead sponsor	Centre Hospitalier Universitaire de Nīmes
Status	Completed
Study type	OBSERVATIONAL
Enrollment	55
Start date	26 March 2021
Primary completion	31 December 2021
Estimated completion	31 December 2021
Sites	1 location across France

Drugs / interventions tested

surgical perineal repair

Conditions studied

Complications; Perineal Repair — all drugs for Complications; Perineal Repair →

Sponsor

Centre Hospitalier Universitaire de Nīmes

Who can join

18 and older, female only, with Complications; Perineal Repair. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04835311 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Centre Hospitalier Universitaire de Nīmes
Last refreshed: 4 December 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04835311.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing