Prospective Registry for Patients Undergoing Surgery for Male Stress Urinary Incontinence

NCT02757274 | Active Not Recruiting

• 1 other identifier: EAU-RF 2016-01
• Study Type: observational
• Target: 1,054
• Locations: 9 countries
• Sites: 28

Brief 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

Keywords

Urologic Surgical Procedure; Male

Outcome Measures

Primary Outcomes (1)

• Cure rate

  Cure rate will be the main endpoint of the study, and is defined as urinary continence with no need for use of pads or the use of 1 light security pad. The cure rate after 10 years of study follow up will be calculated together with its 95% Confidence Intervals, for the total patient group as well as for each device subtype.

  10 years after surgery

Other Outcomes (6)

• Time being incontinence-free

  10 years post surgery

• Time being revision-free

  10 years post surgery

• Complications

  At year 1, year 3, year 5, year 7, year 10

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male patients undergoing surgery for treatment of stress urinary incontinence by AUS or male sling

You may qualify if:

• Male patient undergoing surgery for stress incontinence by AUS or male sling.
• Participant is willing and able to complete the questionnaires and give informed consent for participation in the study.

You may not qualify if:

• Participating center is unable to contribute consecutive patients.

Sponsors & Collaborators

• European Association of Urology Research Foundation: lead
• Boston Scientific Corporation: collaborator

Study Sites (28)

University Hospital Antwerpen

Antwerp, 2650, Belgium

Location

University Hospital Gent

Ghent, 9000, Belgium

Location

Jessa Ziekenhuis campus Salvator

Hasselt, 3500, Belgium

Location

AZ Groeninge

Kortrijk, 8500, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Thomayer Hospital

Prague, 140 59, Czechia

Location

Helsinki University Hospital

Helsinki, 00029 HUS, Finland

Location

University Medical Center Hamburg Eppendorf

Hamburg, 20246, Germany

Location

Universitätsmedizin Mainz

Mainz, 55131, Germany

Location

University Münster

Münster, 48149, Germany

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy

Location

UMC Radboud

Nijmegen, 6525 GA, Netherlands

Location

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

Location

Universitetssykehuset Nord-Norge

Narvik, 8516, Norway

Location

Oslo University Hospital, Rikshospitalet

Oslo, 0372, Norway

Location

Germans Trias i Pujol Universitary Hospital

Barcelona, 08916, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, 18003, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, 08916, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Puerta de Hierro Majadahonda

Madrid, 28222, Spain

Location

Hospital Universitario La Paz

Madrid, 3008, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Spain

Location

Hospital Universitario Morales Meseguer

Murcia, 3008, Spain

Location

Hospital Universitario de Canarias

San Cristóbal de La Laguna, 38320, Spain

Location

University Hospital La Fe

Valencia, 46026, Spain

Location

Addenbrookes Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

Guy's Hospital

London, SE1 9RT, United Kingdom

Location

Royal National Orthopaedic Hospital

Stanmore, HA7 4LP, United Kingdom

Location

Related Publications (3)

• Heesakkers J, Martens F, Thiruchelvam N, Witjes W, Caris C, Kats J, Hamid R, Van der Aa F; EAU Research Foundation SATURN Study Group. Results at 1 Year from SATURN, A European, Prospective, Multicenter Registry for Male Stress Urinary Incontinence Surgery. Eur Urol Focus. 2024 Sep;10(5):818-825. doi: 10.1016/j.euf.2024.04.003. Epub 2024 Apr 15.

  PMID: 38627124 RESULT

• Martens F, Heesakkers J, Van der Aa F, Thiruchelvam N, Witjes W, Caris C, Kats J, Hamid R; EAU Research Foundation SATURN Registry Study Group. SATURN: A European, Prospective, Multicentre Registry for Male Stress Urinary Incontinence Surgery. Eur Urol Open Sci. 2023 Oct 6;57:91-97. doi: 10.1016/j.euros.2023.09.011. eCollection 2023 Nov.

  PMID: 38020526 RESULT

• Thiruchelvam N, Heesakkers J, Hamid R, Martens F, der Aa FV, Witjes W, Caris C, Kats J; European Association of Urology Research Foundation SATURN Registry Study Group. SATURN: A Multinational, Multicentre, Prospective Surgical Registry for Male Urinary Incontinence Surgery Across Europe with Planned 10-year Follow-up. Eur Urol Focus. 2025 Mar;11(2):187-189. doi: 10.1016/j.euf.2025.03.004. Epub 2025 Mar 20.

  PMID: 40118692 RESULT

Related Links

• EAU Research Foundation website

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rizwan Hamid, MD

  Dept of NeuroUrology, London Spinal Injuries Unit, HA7 4LP London, Middlesex, UK

  PRINCIPAL INVESTIGATOR

• John Heesakkers, MD

  Dept. of Urology, MUMC, Maastricht, the Netherlands

  PRINCIPAL INVESTIGATOR

• Frank Van der Aa, MD

  Dept. of Urology, University Hospital Leuven, Belgium

  PRINCIPAL INVESTIGATOR

• Nikesh Thiruchelvam, MD

  Dept. of Urology, CUH-Addenbrooke's Hospital

  PRINCIPAL INVESTIGATOR

• Wim Witjes, MD, PhD

  EAU Research Foundation

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2016
• First Posted: May 2, 2016
• Study Start: February 22, 2017
• Primary Completion (Estimated): February 22, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

CZ (1); NL (2); BE (5); ES (10); GB (3); DE (3); NO (2); FI (1); IT (1)