Clinical trial NCT00212264: Conservative Treatment of Postprostatectomy Incontinence
Official title: Conservative Treatment of Postprostatectomy Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Keywords: urinary incontinence
therapy
prostatectomy
prostate cancer
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2005-09-21
Enrollment: 208
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Percent Change in Incontinence Episodes on Bladder Diary
timeFrame: 2 months
measure: Percent Change in Incontinence Episodes Per Week on Bladder Diary
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Patricia S Goode, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.