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Prevention of Urinary Incontinence After Prostatectomy

U

University Hospital Maggiore della Carità of Novara

Status

Unknown

Conditions

Urinary Incontinence

Treatments

Procedure: BioFeedback; Functional Electrical Stimulation; Pelvic Floor Muscle training exercises

Study type

Interventional

Funder types

Other

Identifiers

NCT00982098
NO08974

Details and patient eligibility

About

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.

Enrollment

110 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • men who will undergo radical prostatectomy for prostatic cancer

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

110 participants in 2 patient groups

Early Rehabilitation
Experimental group
Description:
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.
Treatment:
Procedure: BioFeedback; Functional Electrical Stimulation; Pelvic Floor Muscle training exercises
Counseling and home-based exercises
No Intervention group
Description:
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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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