Conservative Treatment of Postprostatectomy Incontinence

Urinary Incontinence Clinical Trial

Official title:

Conservative Treatment of Postprostatectomy Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00212264
• Other study ID #: DK60044 (completed)
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: October 29, 2013
• Start date: August 2003
• Est. completion date: August 2011

Study information

• Verified date: October 2013
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: August 2011
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: N/A and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Urinary Incontinence

Intervention

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

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 control — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of incontinence episodes on bladder diary 24-hour pad test		2 months and 1 year	No