Prevention of Urinary Incontinence After Prostatectomy

September 21, 2009 updated by: Azienda Ospedaliero Universitaria Maggiore della Carita

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Novara, Italy, 28100
        • SC Medicina Fisica e Riabilitativa AUO "Maggiore della Carità"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early Rehabilitation

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
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).
No Intervention: Counseling and home-based exercises

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?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
PAD test 24 hours
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero Universitaria Maggiore della Carita

Investigators

  • Study Director: Carlo Cisari, prof., AUO "Maggiore della Carità" - Novara
  • Study Chair: Carlo Terrone, prof., AUO "Maggiore della Carità" - Novara

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Anticipated)

November 1, 2009

Study Completion (Anticipated)

November 1, 2009

Study Registration Dates

First Submitted

September 21, 2009

First Submitted That Met QC Criteria

September 21, 2009

First Posted (Estimate)

September 22, 2009

Study Record Updates

Last Update Posted (Estimate)

September 22, 2009

Last Update Submitted That Met QC Criteria

September 21, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NO08974

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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