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Prospective Registry for Patients Undergoing Surgery for Male Stress Urinary Incontinence

NCT02757274 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1054

Last updated 2026-02-02

No results posted yet for this study

Summary

This will be a prospective collection of pre-defined parameters on the treatment of male stress urinary incontinence by an artificial urinary sphincter (AUS) and male sling. The data collection will be undertaken from multiple centers in Europe. The participation will be by open invitation to all members of the Female \& Functional Section of the EAU (ESFFU) along with other urologists undertaking these procedures. There will be a call via the European Association of urology (EAU) to all European Urologists to register for database entry. There will be no restriction on the number of patients enrolled as long as they are consecutive. The aim is to have a long term collection of the data set from as many centers as possible. An initial assessment for the robustness of the data collection will be undertaken at 3 months by a nominated steering committee. However, the first clinical evaluation of the data collected will commence at 1 year by the steering committee. Thereafter, the evaluations will be performed after every 2 years.

Conditions

  • Urinary Incontinence, Stress

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • European Association of Urology Research Foundation

    lead OTHER

Principal Investigators

  • Rizwan Hamid, MD · Dept of NeuroUrology, London Spinal Injuries Unit, HA7 4LP London, Middlesex, UK

  • John Heesakkers, MD · Dept. of Urology, MUMC, Maastricht, the Netherlands

  • Frank Van der Aa, MD · Dept. of Urology, University Hospital Leuven, Belgium

  • Nikesh Thiruchelvam, MD · Dept. of Urology, CUH-Addenbrooke's Hospital

  • Wim Witjes, MD, PhD · EAU Research Foundation

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-22
Primary Completion
2027-02-22
Completion
2027-07-31

Countries

  • Belgium
  • Czechia
  • Finland
  • Germany
  • Italy
  • Netherlands
  • Norway
  • Spain
  • United Kingdom

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 NCT02757274 on ClinicalTrials.gov