Conservative Treatment of Postprostatectomy Incontinence - Full Text View

Sponsored by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00212264

Purpose

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	Intervention
Urinary Incontinence	Behavioral: Behavioral Therapy Device: Pelvic Floor Electrical Stimulation Behavioral: Biofeedback Behavioral: Self Monitoring with Bladder Diaries

MedlinePlus related topics: Pelvic Support Problems Urinary Incontinence

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Conservative Treatment of Postprostatectomy Incontinence

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:

Frequency of incontinence episodes on bladder diary 24-hour pad test [ Time Frame: 2 months and 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	August 2003
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Behavioral Therapy	Behavioral: Behavioral Therapy Pelvic Floor Muscle Exercises and Bladder control strategies Behavioral: Self Monitoring with Bladder Diaries Self Monitoring with Bladder Diaries
2: Experimental Behavior plus technologies	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 Behavioral: Self Monitoring with Bladder Diaries Self Monitoring with Bladder Diaries
3: Placebo Comparator No treatment control	Behavioral: Self Monitoring with Bladder Diaries Self Monitoring with Bladder Diaries

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.

Eligibility

Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00212264

Locations

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

Principal Investigator:

Patricia S Goode, MD

University of Alabama at Birmingham

More Information

Responsible Party:	University of Alabama at Birmingham ( Patricia S Goode, MD )
Study ID Numbers:	DK60044
Study First Received:	September 13, 2005
Last Updated:	June 19, 2008
ClinicalTrials.gov Identifier:	NCT00212264
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

urinary incontinence
therapy
prostatectomy
prostate cancer

Study placed in the following topic categories:

Signs and Symptoms
Urologic Diseases
Urination Disorders
Urinary Incontinence
Prostatic Neoplasms

Additional relevant MeSH terms:

Urological Manifestations

ClinicalTrials.gov processed this record on January 14, 2009