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RECRUITING
NCT05771168

Surgery for Male Stress Urinary Incontinence

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

View on ClinicalTrials.gov

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.

Official title: Observational Study for Patients Undergoing Surgery for Male Stress Urinary Incontinence

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

138

Start Date

2022-09-29

Completion Date

2027-09-29

Last Updated

2023-03-16

Healthy Volunteers

No

Interventions

DEVICE

Artificial urinary sphincter

Implantation of peri-urethral artificial urinary sphincter

DEVICE

Male sling

Retrourethral implantation of male sling

Locations (1)

Università Cattolica del Sacro Cuore, Fondazione Policlinico Agostino Gemelli

Roma, Rome, Italy