Evaluating surgical options for male urinary incontinence
Observational Study for Patients Undergoing Surgery for Male Stress Urinary Incontinence
This study looks at how well different surgeries for male urinary incontinence, like artificial sphincters and slings, work over five years to help men feel better and improve their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 138 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma, Rome) |
| Trial ID | NCT05771168 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the success rates of surgical treatments for male stress urinary incontinence, specifically focusing on artificial urinary sphincters and male slings over a five-year follow-up period. It will collect data on patient demographics, surgical details, and various preoperative and postoperative assessments, including quality of life questionnaires. The study will also analyze prognostic factors that may influence surgical outcomes, such as incontinence rates and the need for revisions.
Who should consider this trial
Good fit: Ideal candidates for this study are male patients undergoing surgery for stress urinary incontinence using devices like artificial urinary sphincters or slings.
Not a fit: Patients who are unable to complete the required questionnaires or decline to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of surgical treatments for male stress urinary incontinence, leading to improved patient outcomes.
How similar studies have performed: Other studies have shown success with similar surgical approaches for urinary incontinence, indicating that this methodology is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male patients undergoing surgery for stress incontinence using medical devices such as AUS or sling * Participant is willing and able to complete the questionnaires and give informed consent for participation in the study Exclusion Criteria: \- Participant unable to complete the questionnaires and declining informed consent for participation in the study
Where this trial is running
Roma, Rome
- Università Cattolica del Sacro Cuore, Fondazione Policlinico Agostino Gemelli — Roma, Rome, Italy (Recruiting)
Study contacts
- Study coordinator: Emilio Sacco, Professor
- Email: emilio.sacco@policlinicogemelli.it
- Phone: +390630155290
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.