Conservative Treatment of Postprostatectomy Incontinence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Patricia Goode, MD, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00212264
First received: September 13, 2005
Last updated: March 21, 2016
Last verified: March 2016
  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
Other: No Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Conservative Treatment of Postprostatectomy Incontinence

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Percent Change in Incontinence Episodes on Bladder Diary [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    [(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 ] [ Designated as safety issue: No ]
    [(Baseline incontinence episodes minus 12-month incontinence episodes)/baseline incontinence episodes] x 100%


Enrollment: 208
Study Start Date: August 2003
Study Completion Date: August 2011
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Any unstable medical condition, particularly decompensated congestive heart failure, history of malignant arrhythmias, or unstable angina
  2. Cardiac pacemaker or implanted cardiac defibrillator
  3. Current use of anticholinergic agents for detrusor instability
  4. Folstein's Mini-Mental State Exam score below 24 (impaired mental status)
  5. One-week bladder diary with continual leakage - defined as always being damp or wet or unable to quantitate individual accidents.
  6. Poorly controlled diabetes, defined as (glycosylated hemoglobin > 9 within last 3 months).
  7. Hematuria on microscopic examination. Enrollment will be permitted after urologic evaluation.
  8. Urodynamic evaluation: Post-void residual volume greater than 200 mL
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
Responsible Party: Patricia Goode, MD, Principal Investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00212264     History of Changes
Other Study ID Numbers: DK60044 (completed) 
Study First Received: September 13, 2005
Results First Received: October 7, 2014
Last Updated: March 21, 2016
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

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 21, 2016