Observational Study for Patients Undergoing Surgery for Male Stress Urinary Incontinence
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Male Stress Urinary Incontinence
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Enrollment
- 138
- Locations
- 1
- Primary Endpoint
- Success rate (cure plus improvement)
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief 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.
Detailed Description
Through the use of a prospective registry, the investigators will collect information on patient characteristics, including age (years), weight (kg), length (cm), previous urological surgeries and other surgeries in the pelvic area, radiotherapeutic treatment of the prostate, and other co-morbidities. Also, if applicable, 24h pad test and preoperative urodynamic results, presence of pre-operative urinary tract infections, and results of preoperative cystoscopy will be reported. The surgical procedure for treatment of male stress urinary incontinence is according to standard practice. For artificial urinary sphincters, the date and time of surgery, surgeon name, time of shaving, presence of skin wounds, type of prosthesis, cuff location, cuff size, pressure regulating balloon, type of preoperative antibiotics, type of associated procedures will be reported. For slings, similar data will be reported, including type of sling and if there was a release of central tendon. The patients will fill in the International Consultation on Incontinence Questionnaire (ICIQ) Urinary Incontinence (UI) Short Form (ICIQ-UI Questionnaire SF), the EuroQol Group Questionnaire (EQ-5D-5L) for the evaluation of the impact of incontinence on Quality of Life, and the Sexual Complaints Screener for Men (SCS-M), the Dyadic Adjustment Scale Italian version (DAS), the International Index of Erectile Function Questionnaire (IIEF-15) and the Hospital Anxiety and Depression Scale (HADS) questionnaire before the operation, at 12 weeks after surgery and at yearly intervals up to and including year 5. The results of questionnaires will be entered into the database.
Investigators
Sacco Emilio
Associate Professor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Participant unable to complete the questionnaires and declining informed consent for participation in the study
Outcomes
Primary Outcomes
Success rate (cure plus improvement)
Time Frame: 5-years after surgery
Will be obtained through patient 24-hour pad use. Cure rate is defined as urinary continence with no need for use of pads or the use of 1 light security pad.
Secondary Outcomes
- Time being revision-free(12-weeks, 12-months, 2-years, 3-years, 4-years, 5-years)
- Time being continent(12-weeks, 12-months, 2-years, 3-years, 4-years, 5-years)
- Revision-free rate(5-years after surgery)
- Patient-reported quality of life(12-weeks, 12-months, 2-years, 3-years, 4-years, 5-years)
- Post-operative specific adverse events(12-weeks, 12-months, 2-years, 3-years, 4-years, 5-years)
- Post-operative general adverse events(12-weeks, 12-months, 2-years, 3-years, 4-years, 5-years)