Clinical trial NCT05771168: Surgery for Male Stress Urinary Incontinence
Official title: Observational Study for Patients Undergoing Surgery for Male Stress Urinary Incontinence
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Male Stress Urinary Incontinence
Keywords: Urinary incontinence
Male incontinence
Post-prostatectomy incontinence
Radical prostatectomy
Male sling
Artificial urinary sphincter
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 138
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult male patients undergoing surgery for treatment of stress urinary incontinence (AUS or male sling)

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.

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

Primary outcomes:
measure: Success rate (cure plus improvement)
timeFrame: 5-years after surgery
Secondary outcomes:
measure: Time being continent
timeFrame: 12-weeks, 12-months, 2-years, 3-years, 4-years, 5-years
measure: Time being revision-free
timeFrame: 12-weeks, 12-months, 2-years, 3-years, 4-years, 5-years
measure: Revision-free rate
timeFrame: 5-years after surgery
measure: Patient-reported quality of life
timeFrame: 12-weeks, 12-months, 2-years, 3-years, 4-years, 5-years
measure: Post-operative general adverse events
timeFrame: 12-weeks, 12-months, 2-years, 3-years, 4-years, 5-years
measure: Post-operative specific adverse events
timeFrame: 12-weeks, 12-months, 2-years, 3-years, 4-years, 5-years
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Università Cattolica del Sacro Cuore, Fondazione Policlinico Agostino Gemelli
state: Rome
Study officials:
References: