Prevention of Urinary Incontinence After Prostatectomy

Not Applicable

• Conditions: Urinary Incontinence
• Interventions: Procedure: BioFeedback; Functional Electrical Stimulation; Pelvic Floor Muscle training exercises

• Registration Number: NCT00982098
• Lead Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Status Verified: 2009-09
• Study First Submitted: 2009-09-21
• Study First Submitted QC: 2009-09-21
• Last Update Submitted: 2009-09-21
• Study First Posted: 2009-09-22
• Last Update Posted: 2009-09-22
• Primary Completion: 2009-11
• Study Completion: 2009-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 110

Inclusion Criteria

• men who will undergo radical prostatectomy for prostatic cancer

Exclusion Criteria

• previous urinary and/or faecal incontinence
• neurologic bladder
• previous pelvic surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early Rehabilitation	BioFeedback; Functional Electrical Stimulation; Pelvic Floor Muscle training exercises	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.

Primary Outcome Measures

Name	Time	Method
Complete continence (PAD test 24 hours <10 cc)	12 months

Secondary Outcome Measures

Name	Time	Method
PAD test 24 hours	12 months

Trial Locations

Locations (1)

SC Medicina Fisica e Riabilitativa AUO "Maggiore della Carità"; 🇮🇹 Novara, Italy