NCT07399509

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
33mo left

Started Feb 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress12%
Feb 2026Feb 2029

First Submitted

Initial submission to the registry

January 27, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 10, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2029

Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

January 27, 2026

Last Update Submit

February 6, 2026

Conditions

Female Artificial Urinary Sphincter Implantation

Keywords

Artificial urinary sphincterUrinary IncontinenceSexual functionSexual quality of life

Outcome Measures

Primary Outcomes (1)

  • Assess sexual function

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

    6 months

Secondary Outcomes (6)

  • Assess sexual function

    12 months

  • Assess sexual quality of life

    6 and 12 months

  • Assess urinary incontinence (clinical efficacy)

    6 and 12 months

  • Assess urinary incontinence (clinical efficacy)

    6 and 12 months

  • Assess quality of life

    6 and 12 months

  • +1 more secondary outcomes

Interventions

questionnairesOTHER

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.

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Tenon, service d'urologie

Paris, 75020, France

Location

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Véronique PHE, PU-PH

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Véronique PHE, PU-PH

CONTACT

01.56.01.61.95veronique.phe@aphp.fr

Nour KHALIL, PhD

CONTACT

01.56.01.61.95nour.khalil@aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2026

First Posted

February 10, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2029

Last Updated

February 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)