Surgery for Male Stress Urinary Incontinence

Male Stress Urinary Incontinence Clinical Trial

— SMUI  

Official title:

Observational Study for Patients Undergoing Surgery for Male Stress Urinary Incontinence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05771168
• Other study ID #: ID 5094
• Status: Recruiting
• Start date: September 29, 2022
• Est. completion date: September 29, 2027

Study information

• Verified date: February 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Emilio Sacco, Professor
• Phone: +390630155290
• Email: emilio.sacco[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: September 29, 2027
• Est. primary completion date: September 29, 2027
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Male Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• Artificial urinary sphincter
Implantation of peri-urethral artificial urinary sphincter
• Male sling
Retrourethral implantation of male sling

Locations

Country	Name	City	State
Italy	Università Cattolica del Sacro Cuore, Fondazione Policlinico Agostino Gemelli	Roma	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate (cure plus improvement)	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.	5-years after surgery
Secondary	Time being continent	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.	12-weeks, 12-months, 2-years, 3-years, 4-years, 5-years
Secondary	Time being revision-free	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.	12-weeks, 12-months, 2-years, 3-years, 4-years, 5-years
Secondary	Revision-free rate	Evaluation of revision-free rate at 5 years of study follow-up	5-years after surgery
Secondary	Patient-reported quality of life	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)	12-weeks, 12-months, 2-years, 3-years, 4-years, 5-years
Secondary	Post-operative general adverse events	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)	12-weeks, 12-months, 2-years, 3-years, 4-years, 5-years
Secondary	Post-operative specific adverse events	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)	12-weeks, 12-months, 2-years, 3-years, 4-years, 5-years