Surgery for Male Stress Urinary Incontinence

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

138 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-29

Study Completion Date

2027-09-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Male Stress Urinary Incontinence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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AUS

Male patients undergoing surgery for stress urinary incontinence using artificial urinary sphincter (AUS)

Artificial urinary sphincter

Intervention Type DEVICE

Implantation of peri-urethral artificial urinary sphincter

Sling

Male patients undergoing surgery for stress urinary incontinence using slings

Male sling

Intervention Type DEVICE

Retrourethral implantation of male sling

Interventions

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Artificial urinary sphincter

Implantation of peri-urethral artificial urinary sphincter

Intervention Type DEVICE

Male sling

Retrourethral implantation of male sling

Intervention Type DEVICE

Eligibility Criteria

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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