Observational Study for Patients Undergoing Surgery for Male Stress Urinary Incontinence

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Università Cattolica del Sacro Cuore, Fondazione Policlinico Agostino Gemelli
RECRUITING
Roma
Contact Information
Primary
Emilio Sacco, Professor
emilio.sacco@policlinicogemelli.it
+390630155290
Time Frame
Start Date: 2022-09-29
Estimated Completion Date: 2027-09-29
Participants
Target number of participants: 138
Treatments
AUS
Male patients undergoing surgery for stress urinary incontinence using artificial urinary sphincter (AUS)
Sling
Male patients undergoing surgery for stress urinary incontinence using slings
Sponsors
Leads: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

This content was sourced from clinicaltrials.gov