Questionnaires in Female Artificial Urinary Sphincter Implantation - Clinical Trials Registry

Study Overview

Status

Not yet recruiting

Conditions

Female Artificial Urinary Sphincter Implantation

Intervention / Treatment

Other: questionnaires

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

Name: Véronique PHE, PU-PH
Phone Number: +33 01.56.01.61.95
Email: veronique.phe@aphp.fr

Study Contact Backup

Name: Nour KHALIL, PhD
Phone Number: +33 01.56.01.61.95
Email: nour.khalil@aphp.fr

Study Locations

France
- - Paris, France, 75020
    - Hôpital Tenon, service d'urologie
    - Contact:
      
      Véronique PHE, PU-PH
      
      Phone Number: +33 01.56.01.61.95
      
      Email: veronique.phe@aphp.fr
    - Contact:
      
      Nour KHALIL, PhD
      
      Phone Number: +33 01.56.01.61.95
      
      Email: nour.khalil@aphp.fr

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)