SATURN 1.4
Research type
Research Database
IRAS ID
233174
Contact name
Rizwan Hamid
Contact email
Research summary
Prospective Registry for Patients Undergoing Surgery for Male Stress Urinary Incontinence in Multiple European Centres
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
17/EM/0413
Date of REC Opinion
8 Nov 2017
REC opinion
Unfavourable Opinion
Data collection arrangements
To prospectively collect an anonyimsed pre-defined dataset including demographic details, surgical details, outcomes and quality of life from male patients undergoing surgical treatment with medical devices such as AUS or male slings as a treatment for stress urinary incontinence from multiple centres in Europe for evaluation of short and long term efficacy and complications of these procedures along with impact on Quality of Life. Data will include, Time being continent Time being revision-free which is defined as the interval from the date of surgery to the date of revision.Revision-free rate at 5 years of study follow-up.The change in the results of the incontinence questionnaires and quality of life questionnaires compared with baseline over time.Postoperative general events related to the surgical procedure or the sling/sphincter (e.g. urinary retention, scrotal hematoma , perineal pain, hematuria, or other general problems.
Postoperative specific events related to the surgical procedure or the sling / prosthesis (e.g. pump/reservoir/cuff failure, erosion of the device through the skin or urethra.Research programme
The participation will be by open invitation to all members of the Female & Functional Section of the EAU along with other urologists undertaking these procedures. There will also be a call via the EAU to all European Urologists to register for database entry.
Research database title
Prospective Registry for Patients Undergoing Surgery for Male Stress Urinary Incontinence in Multiple European Centres
Establishment organisation
EAU Foundation for Urological Research (EAU RF)
Establishment organisation address
Mr. E.N. van Kleffensstraat 5
6842 CV Arnhem