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Prevention of Urinary Incontinence After Prostatectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00982098
Recruitment Status : Unknown
Verified September 2009 by Azienda Ospedaliero Universitaria Maggiore della Carita.
Recruitment status was:  Active, not recruiting
First Posted : September 22, 2009
Last Update Posted : September 22, 2009
Sponsor:
Information provided by:
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.


Condition or disease Intervention/treatment Phase
Urinary Incontinence Procedure: BioFeedback; Functional Electrical Stimulation; Pelvic Floor Muscle training exercises Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : February 2007
Estimated Primary Completion Date : November 2009
Estimated Study Completion Date : November 2009

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Complete continence (PAD test 24 hours <10 cc) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. PAD test 24 hours [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • men who will undergo radical prostatectomy for prostatic cancer

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00982098


Locations
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Italy
SC Medicina Fisica e Riabilitativa AUO "Maggiore della Carità"
Novara, Italy, 28100
Sponsors and Collaborators
Azienda Ospedaliero Universitaria Maggiore della Carita
Investigators
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Study Director: Carlo Cisari, prof. AUO "Maggiore della Carità" - Novara
Study Chair: Carlo Terrone, prof. AUO "Maggiore della Carità" - Novara
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Responsible Party: Carlo Cisari, AUO "Maggiore della Carità"
ClinicalTrials.gov Identifier: NCT00982098    
Other Study ID Numbers: NO08974
First Posted: September 22, 2009    Key Record Dates
Last Update Posted: September 22, 2009
Last Verified: September 2009
Keywords provided by Azienda Ospedaliero Universitaria Maggiore della Carita:
Prostatectomy
Prostatic cancer
Urinary incontinence
Exercise
Electric stimulation therapy
Counseling
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders