Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07399509

Evaluation of Sexual Function After Artificial Urinary Sphincter Implantation

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Female Artificial Urinary Sphincter Implantation Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

questionnaires

Other

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.

Primary outcomes

  1. Assess sexual function

    Time frame: 6 months

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

Secondary outcomes

  1. Assess sexual function

    Time frame: 12 months

    sexual quality of life assessed at 12 months post operatively by the PISQ-12 questionnaire.

  2. Assess sexual quality of life

    Time frame: 6 and 12 months

    sexual quality of life assessed at 6 and 12 months post operatively by the ICIQ-FLUTSsex questionnaire.

  3. Assess urinary incontinence (clinical efficacy)

    Time frame: 6 and 12 months

    sexual quality of life assessed at 6 and 12 months post operatively by the USP questionnaire.

  4. Assess urinary incontinence (clinical efficacy)

    Time frame: 6 and 12 months

    A voiding diary at 6 and 12 months (reporting the number of leaks per day),with a comparison to the preoperative value. Where applicable, the number of pads used per day.

  5. Assess quality of life

    Time frame: 6 and 12 months

    Quality of life assessed at 6 and 12 months post operatively by the Qualiveen SF questionnaire.

  6. Assess complications

    Time frame: 6 and 12 months

    Surgical complications assessed at 6 and 12 months post according to the Calvien Dindo.

Study contacts

Contact information is provided by the study sponsor or research team.

Nour KHALIL, PhD

CONTACT

[email protected]

01.56.01.61.95 ext. +33

Véronique PHE, PU-PH

CONTACT

[email protected]

01.56.01.61.95 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: SPHINCTER

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Feb 10, 2026
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.