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Conservative Treatment of Postprostatectomy Incontinence


N/A
N/A
N/A
Not Enrolling
Male
Urinary Incontinence

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Trial Information

Conservative Treatment of Postprostatectomy Incontinence


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Frequency of incontinence episodes on bladder diary 24-hour pad test

Outcome Time Frame:

2 months and 1 year

Safety Issue:

No

Principal Investigator

Patricia S Goode, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alabama at Birmingham

Authority:

United States: Federal Government

Study ID:

DK60044 (completed)

NCT ID:

NCT00212264

Start Date:

August 2003

Completion Date:

June 2009

Related Keywords:

  • Urinary Incontinence
  • urinary incontinence
  • therapy
  • prostatectomy
  • prostate cancer
  • Urinary Incontinence

Name

Location
University of Alabama at Birmingham Birmingham, Alabama  35294-3300