SPHINCTEREvaluation of Women's Sexual Function After Artificial Urinary Sphincter Implantation
This study aims to observe and evaluate the sexual function and quality of life in women, 6 months after they have undergone an artificial urinary sphincter implantation, using the PISQ-12 questionnaire.
Data Collection
Collected from today forward - ProspectiveUrogenital Diseases+8
+ Female Urogenital Diseases and Pregnancy Complications
+ Signs and Symptoms
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: February 1, 2026
Actual date on which the first participant was enrolled.This study focuses on evaluating the sexual function of women who have undergone a procedure to implant an artificial urinary sphincter. The primary goal is to understand how this medical device affects their sexual quality of life. The study is important as it aims to provide insights into the potential impacts of this treatment, helping to address any concerns or expectations women might have before deciding on this procedure. Participants in this study are women who have already received an artificial urinary sphincter. They will be fully informed about the study during their preoperative consultation and given an information sheet. Consent will be collected either during the consultation or on the day of the procedure, allowing ample time for reflection. To measure the results, participants will complete questionnaires during their follow-up visits, specifically at 6 and 12 months after the operation. The sexual quality of life will be assessed using the PISQ-12 questionnaire, which scores from 0 to 48.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 18 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location