Actively Recruiting

Age: 18Years +
MALE
NCT05771168

Surgery for Male Stress Urinary Incontinence

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2023-03-16

138

Participants Needed

1

Research Sites

260 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

Surgery for Male Stress Urinary Incontinence

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Participant unable to complete the questionnaires and declining informed consent for participation in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Università Cattolica del Sacro Cuore, Fondazione Policlinico Agostino Gemelli

Roma, Rome, Italy, 00168

Actively Recruiting

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Research Team

E

Emilio Sacco, Professor

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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