Male Stress Urinary Incontinence
Conditions
Keywords
Urinary incontinence, Male incontinence, Post-prostatectomy incontinence, Radical prostatectomy, Male sling, Artificial urinary sphincter
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.
Interventions
Implantation of peri-urethral artificial urinary sphincter
DEVICEMale sling
Retrourethral implantation of male sling
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate (cure plus improvement) | 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
| Measure | Time frame | Description |
|---|---|---|
| Revision-free rate | 5-years after surgery | Evaluation of revision-free rate at 5 years of study follow-up |
| Time being continent | 12-weeks, 12-months, 2-years, 3-years, 4-years, 5-years | Interval being continent after surgery to the date of incontinence recurrence. Patients who die will be censored at time of death. Overall time of being continent will be presented using the Kaplan-Meier curve. |
| Time being revision-free | 12-weeks, 12-months, 2-years, 3-years, 4-years, 5-years | Interval from the date of surgery to the date of revision.Patients who die will be censored at time of death. Overall time of being revision-free will be presented using the Kaplan-Meier curve. |
| Post-operative general adverse events | 12-weeks, 12-months, 2-years, 3-years, 4-years, 5-years | Post-operative general adverse events related to the surgical procedure or the sling/sphincter (e.g. urinary retention, scrotal hematoma, perineal pain, hematuria, or other general problems) |
| Post-operative specific adverse events | 12-weeks, 12-months, 2-years, 3-years, 4-years, 5-years | Post-operative specific adverse events related to the surgical procedure or the sling/sphincter (e.g. pump/reservoir/cuff failure, erosion of the device through the skin or urethra) |
| Patient-reported quality of life | 12-weeks, 12-months, 2-years, 3-years, 4-years, 5-years | The change in the results of quality of life questionnaires (EuroQol Group EQ-5D-5L) compared with baseline over time and correlations with the primary outcome. EuroQol Group EQ-5D-5L describe health state with 5 levels (level 1 indicating no problem, level 2 indicating slight problems, level 3 indicating moderate problems, level 4 indicating severe problems, level 5 indicating unable to/extreme problems) and with a scale numbered from 0 to 100 (100 means the best health you can imagine and 0 means the worst health you can imagine) |
Countries
Italy
Contacts
Primary ContactEmilio Sacco, Professor
Outcome results
None listed