Evaluation of Sexual Function After Artificial Urinary Sphincter Implantation (SPHINCTER)

February 6, 2026 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Paris, France, 75020
        • Hôpital Tenon, service d'urologie
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who have benefited from the surgical implantation of an artificial urinary sphincter

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess sexual function
Time Frame: 12 months
sexual quality of life assessed at 12 months post operatively by the PISQ-12 questionnaire.
12 months
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.
6 and 12 months
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.
6 and 12 months
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.
6 and 12 months
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 and 12 months
Assess complications
Time Frame: 6 and 12 months
Surgical complications assessed at 6 and 12 months post according to the Calvien Dindo.
6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Véronique PHE, PU-PH, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2029

Study Registration Dates

First Submitted

January 27, 2026

First Submitted That Met QC Criteria

February 6, 2026

First Posted (Actual)

February 10, 2026

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 6, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP251272
  • 2025-A01903-46 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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