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Clinical Trials in France / NCT07399509
Starting soon Observational

Evaluation of Sexual Function After Artificial Urinary Sphincter Implantation

NCT07399509 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Observational
Started
2026-02
Last updated
2026-02-10

Condition(s) studied

Female Artificial Urinary Sphincter Implantation

Investigational drug(s) / intervention(s)

questionnaires

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.

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Women aged 18 to 80 years * Patients with from urinary incontinence with an appropriate surgical indication for artificial urinary sphincter implantation * Patients who accept the surgical indication and have signed the informed consent for the procedure * No objection from the patients to participate in the study after reading the information sheet Exclusion Criteria: * \- Pregnant or breastfeeding patients * Life expectancy of less than 2 years * Patients who have undergone colpocleisis surgery * Patients with neurological conditions causing loss of sensation * Patients reporting no interest in sexual activity * Patients suffering from chronic pelvic pain

Primary outcome measure(s)

  • Assess sexual function — 6 months
    sexual quality of life assessed at 6 months post operatively by the PISQ-12 questionnaire (scale from 0 to 48).

Trial sites (1)

FacilityCityRegionStatus
Hôpital Tenon, service d'urologie Paris France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07399509 on ClinicalTrials.gov ↗ ← All trials in France