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: October 29, 2013
Last verified: October 2013

September 13, 2005
October 29, 2013
August 2003
September 2008   (final data collection date for primary outcome measure)
Frequency of incontinence episodes on bladder diary 24-hour pad test [ Time Frame: 2 months and 1 year ] [ Designated as safety issue: No ]
  • 1. Frequency of incontinence episodes on bladder diary
  • 2. 24-hour pad test
Complete list of historical versions of study NCT00212264 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Not Provided
 
Conservative Treatment of Postprostatectomy Incontinence
Conservative Treatment of Postprostatectomy Incontinence

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Urinary Incontinence
  • 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
  • Experimental: Behavioral Therapy
    Behavioral Therapy (Pelvic floor muscle training, bladder control strategies)
    Intervention: Behavioral: Behavioral Therapy
  • Experimental: Behavioral Therapy Plus Technologies
    Behavioral therapy plus technologies (home pelvic floor electrical stimulation and biofeedback)
    Interventions:
    • Behavioral: Behavioral Therapy
    • Device: Pelvic Floor Electrical Stimulation
    • Behavioral: Biofeedback
  • Placebo Comparator: Placebo Comparator
    No treatment control
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
208
August 2011
September 2008   (final data collection date for primary outcome measure)

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
Male
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00212264
DK60044 (completed)
No
Patricia Goode, MD, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Not Provided
Principal Investigator: Patricia S Goode, MD University of Alabama at Birmingham
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP