Prospective Observational Study Evaluating the Sexual Function After Insertion of an Artificial Urinary Sphincter in Women
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Assess sexual function
Study Overview
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.
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
- Assess sexual function(12 months)
- Assess sexual quality of life(6 and 12 months)
- Assess urinary incontinence (clinical efficacy)(6 and 12 months)
- Assess quality of life(6 and 12 months)
- Assess complications(6 and 12 months)