Conservative Treatment of Postprostatectomy Incontinence

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ClinicalTrials.gov Identifier: NCT00212264

Recruitment Status : Completed

First Posted : September 21, 2005

Results First Posted : April 11, 2016

Last Update Posted : April 11, 2016

Sponsor:

Information provided by (Responsible Party):

Patricia Goode, MD, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Description

Brief Summary:

The primary purpose of this study is to test the effectiveness, impact on quality of life, and durability of non-surgical therapies for incontinence persisting at least one year after surgery. The study is a a prospective, controlled, randomized trial comparing an 8-week, multi-component behavioral training program (pelvic floor muscle exercises, self-monitoring with bladder diaries, regular office visits, bladder control techniques, and fluid management) to the same program with the addition of biofeedback and pelvic muscle electrical stimulation.

Condition or disease	Intervention/treatment	Phase
Urinary Incontinence	Behavioral: Behavioral Therapy Device: Pelvic Floor Electrical Stimulation Behavioral: Biofeedback Other: No Treatment	Not Applicable

Detailed Description:

The primary purpose of this project is to test the effectiveness, impact on quality of life, and durability of conservative therapies for persistent post-prostatectomy urinary incontinence in a prospective, controlled, randomized trial comparing an 8-week, multi-component behavioral training program (pelvic floor muscle exercises, self-monitoring with bladder diaries, regular office visits, bladder control techniques, and fluid management) to the same program with the addition of biofeedback and pelvic muscle electrical stimulation.

The second purpose of the study is to examine and compare the cost-effectiveness of the 8-week, multi-component behavioral training program to the same program with the addition of biofeedback and pelvic floor electrical stimulation.

Prostate cancer is the most common internal cancer in men in the United States. The most common treatment for early disease is radical prostatectomy, the removal of the prostate gland. The two most common sequelae of prostatectomy are incontinence and erectile dysfunction. The incontinence improves and often resolves in the first year after prostatectomy, but surveys of patients show that 40% of men have incontinence severe enough to require pads 1 and 2 years after their surgery. There are currently no randomized, controlled studies of non-surgical treatments for persistent post-prostatectomy incontinence.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	208 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Conservative Treatment of Postprostatectomy Incontinence
Study Start Date :	August 2003
Actual Primary Completion Date :	September 2008
Actual Study Completion Date :	August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Urinary Incontinence

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Behavioral Therapy Behavioral Therapy (Pelvic floor muscle training, bladder control strategies)	Behavioral: Behavioral Therapy Pelvic Floor Muscle Exercises and Bladder control strategies
Experimental: Behavioral Therapy Plus Technologies Behavioral therapy plus technologies (home pelvic floor electrical stimulation and biofeedback)	Behavioral: Behavioral Therapy Pelvic Floor Muscle Exercises and Bladder control strategies Device: Pelvic Floor Electrical Stimulation Pelvic Floor Electrical Stimulation daily for 8 weeks Behavioral: Biofeedback Pelvic Floor Muscle training via biofeedback
Placebo Comparator: Placebo Comparator No treatment control	Other: No Treatment No treatment

Outcome Measures

Primary Outcome Measures :

Percent Change in Incontinence Episodes on Bladder Diary [ Time Frame: 2 months ]
[(Baseline incontinence episodes minus 2-month incontinence episodes)/baseline incontinence episodes] x 100%
Percent Change in Incontinence Episodes Per Week on Bladder Diary [ Time Frame: 1 year ]
[(Baseline incontinence episodes minus 12-month incontinence episodes)/baseline incontinence episodes] x 100%

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Older Adult
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Involuntary loss of urine that started immediately after radical prostatectomy and has persisted for at least one year.
One-week bladder diary with interpretable data and at least two incontinence episodes

Exclusion Criteria:

Any unstable medical condition, particularly decompensated congestive heart failure, history of malignant arrhythmias, or unstable angina
Cardiac pacemaker or implanted cardiac defibrillator
Current use of anticholinergic agents for detrusor instability
Folstein's Mini-Mental State Exam score below 24 (impaired mental status)
One-week bladder diary with continual leakage - defined as always being damp or wet or unable to quantitate individual accidents.
Poorly controlled diabetes, defined as (glycosylated hemoglobin > 9 within last 3 months).
Hematuria on microscopic examination. Enrollment will be permitted after urologic evaluation.
Urodynamic evaluation: Post-void residual volume greater than 200 mL

Contacts and Locations

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): NCT00212264

Locations

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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294

Sponsors and Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

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Principal Investigator:	Patricia S Goode, MD	University of Alabama at Birmingham

More Information

Publications of Results:

Goode PS, Burgio KL, Johnson TM 2nd, Clay OJ, Roth DL, Markland AD, Burkhardt JH, Issa MM, Lloyd LK. Behavioral therapy with or without biofeedback and pelvic floor electrical stimulation for persistent postprostatectomy incontinence: a randomized controlled trial. JAMA. 2011 Jan 12;305(2):151-9. doi: 10.1001/jama.2010.1972.

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Responsible Party:	Patricia Goode, MD, Principal Investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00212264
Other Study ID Numbers:	DK60044 (completed)
First Posted:	September 21, 2005 Key Record Dates
Results First Posted:	April 11, 2016
Last Update Posted:	April 11, 2016
Last Verified:	March 2016

Keywords provided by Patricia Goode, MD, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):


urinary incontinence therapy prostatectomy prostate cancer

Additional relevant MeSH terms:

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Urinary Incontinence Enuresis Urination Disorders Urologic Diseases Lower Urinary Tract Symptoms	Urological Manifestations Behavioral Symptoms Elimination Disorders Mental Disorders

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