NCT07399509

Evaluation of Sexual Function After Artificial Urinary Sphincter Implantation

Prospective Observational Study Evaluating the Sexual Function After Insertion of an Artificial Urinary Sphincter in Women

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Urinary incontinence (UI) is a common and disabling condition that affects millions of people worldwide and significantly impacts the quality of life of those affected. It is well established that urinary incontinence negatively affects sexual life. Although there is no definitive consensus yet, many authors report that sexual function, after surgical intervention to restore continence, is likely to improve or, at the very least, remain unchanged.

Detailed description

The primary objective of the study is to evaluate sexual function in women 6 months after implantation of an artificial urinary sphincter. Patients will be informed during the preoperative consultation, with an information sheet provided. Consent to non-opposition will be collected either during the preoperative consultation or on the day of the procedure, if additional time for reflection is needed. Questionnaires will be completed during follow-up visits at 6 and 12 months postoperatively. The patients concerned are women who have undergone implantation of an artificial urinary sphincter. Patients will be informed during the preoperative consultation, with an information sheet provided. Consent to non-opposition will be collected either during the preoperative consultation or on the day of the procedure, if additional time for reflection is needed. Questionnaires will be completed during follow-up visits at 6 and 12 months postoperatively.

Conditions

• Female Artificial Urinary Sphincter Implantation

Interventions

Type	Name	Description
OTHER	questionnaires	The PISQ-12 questionnaire, which explores female sexual function; the ICIQ-FLUTSsex questionnaire, which focuses on the impact of urinary leakage on sexuality; the USP questionnaire, which assesses the frequency and characteristics of urinary incontinence; and the Qualiveen-SF questionnaire, which measures the impact of these urinary disorders on daily life. A bladder diary was completed preoperatively as well as during follow-up visits at 6 and 12 months.

Timeline

• Start date: 2026-02-01
• Primary completion: 2028-02-01
• Completion: 2029-02-01
• First posted: 2026-02-10
• Last updated: 2026-02-10

Locations

1 site across 1 country: France