Prevention of Urinary Incontinence After Prostatectomy

Study Overview
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Brief Summary
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Urinary incontinence is a frequent complication after radical prostatectomy. Rehabilitative treatments are frequently utilized to reduce incontinence. However, their efficacy has not been completely investigated. In this study the investigators will compare the effect of an early rehabilitation programme (instruction of the patient, pelvic floor muscle training, electrical stimulation and biofeedback) versus instruction of the patient only. The investigators hypothesis is that early rehabilitation programme is more effective than patient's instruction alone in preventing urinary incontinence after radical prostatectomy.

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Procedure: BioFeedback; Functional Electrical Stimulation; Pelvic Floor Muscle training exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: men who will undergo radical prostatectomy for prostatic cancer Exclusion Criteria: previous urinary and/or faecal incontinence neurologic bladder previous pelvic surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Rehabilitation<br>Before surgery: 15 minutes pelvic floor muscle training and 15 minutes biofeedback, for 4 sessions. After surgery: physical therapist's assisted pelvic floor muscle biofeedback (15 min/day for 10 days), followed by patient's instruction for pelvic floor muscle training and home based exercised pelvic floor muscle for 10 days. Then pelvic floor muscle biofeedback (15 min/day for 10 days) and functional electrical stimulation of pelvic floor (30 min/day for 10 days). Patients will be instructed to carry on exercises at home for the following 11 months. | Procedure: BioFeedback; Functional Electrical Stimulation; Pelvic Floor Muscle training exercises<br>* After surgery: physical therapist's assisted pelvic floor muscle biofeedback (15 min/day for 10 days), followed by patient's instruction for pelvic floor muscle training and home based exercised pelvic floor muscle for 10 days. Then pelvic floor muscle biofeedback (15 min/day for 10 days) and functional electrical stimulation of pelvic floor (30 min/day for 10 days).<br>|
| No Intervention: Counseling and home-based exercises<br>Before surgery: 15 minutes pelvic floor muscle training and 15 minutes biofeedback, for 4 sessions. After surgery: Patients will be instructed to carry on pelvic floor exercises at home for the year after prostatectomy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete continence (PAD test 24 hours <10 cc) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PAD test 24 hours |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostatectomy, Prostatic cancer, Urinary incontinence, Exercise, Electric stimulation therapy, Counseling