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Surgery for Male Stress Urinary Incontinence

NCT05771168 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 138

Last updated 2023-03-16

No results posted yet for this study

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.

Conditions

  • Male Stress Urinary Incontinence

Interventions

DEVICE

Artificial urinary sphincter

Implantation of peri-urethral artificial urinary sphincter

DEVICE

Male sling

Retrourethral implantation of male sling

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-29
Primary Completion
2027-09-29
Completion
2027-09-29

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05771168 on ClinicalTrials.gov