NCT05771168 Surgery for Male Stress Urinary Incontinence
| NCT ID | NCT05771168 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Male Stress Urinary Incontinence |
| Study Type | OBSERVATIONAL |
| Enrollment | 138 participants |
| Start Date | 2022-09-29 |
| Primary Completion | 2027-09-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 138 participants in total. It began in 2022-09-29 with a primary completion date of 2027-09-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this observational prospective study is to evaluate the success rate (cure plus improvement) of procedures for treatment of male stress urinary incontinence (artificial urinary sphincter or male slings) at 5 years of study follow-up and to determine other outcomes of surgical treatment for each of the devices and, to perform a prognostic factor analysis to identify clinical and surgical variables that correlate with (in)continence or revisions for each of the device subtypes. Cure is defined as urinary continence with no need for use of pads or the use of 1 light security pad; the improvement is defined as the reduction of≥ 50% of the number of pads with use of no more than two pads.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05771168 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Male Stress Urinary Incontinence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05771168 currently recruiting?
Yes, NCT05771168 is actively recruiting participants. Contact the research team at emilio.sacco@policlinicogemelli.it for enrollment information.
Where is the NCT05771168 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT05771168 clinical trial?
NCT05771168 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 138 participants.