Conservative Treatment of Postprostatectomy Incontinence

NCT ID: NCT00212264

Last Updated: 2016-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-08-31
• Study Completion Date: 2011-08-31

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.

Conditions

Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Behavioral Therapy

Behavioral Therapy (Pelvic floor muscle training, bladder control strategies)

Group Type: EXPERIMENTAL

Behavioral Therapy

Intervention Type: BEHAVIORAL

Pelvic Floor Muscle Exercises and Bladder control strategies

Behavioral Therapy Plus Technologies

Behavioral therapy plus technologies (home pelvic floor electrical stimulation and biofeedback)

Group Type: EXPERIMENTAL

Behavioral Therapy

Intervention Type: BEHAVIORAL

Pelvic Floor Muscle Exercises and Bladder control strategies

Pelvic Floor Electrical Stimulation

Intervention Type: DEVICE

Pelvic Floor Electrical Stimulation daily for 8 weeks

Biofeedback

Intervention Type: BEHAVIORAL

Pelvic Floor Muscle training via biofeedback

Placebo Comparator

No treatment control

Group Type: PLACEBO_COMPARATOR

No Treatment

Intervention Type: OTHER

No treatment

Interventions

Behavioral Therapy

Pelvic Floor Muscle Exercises and Bladder control strategies

Intervention Type: BEHAVIORAL

Pelvic Floor Electrical Stimulation

Pelvic Floor Electrical Stimulation daily for 8 weeks

Intervention Type: DEVICE

Biofeedback

Pelvic Floor Muscle training via biofeedback

Intervention Type: BEHAVIORAL

No Treatment

No treatment

Intervention Type: OTHER

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

• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: lead

Responsible Party

Patricia Goode, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patricia S Goode, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 21224456 (View on PubMed)

Johnson EE, Mamoulakis C, Stoniute A, Omar MI, Sinha S. Conservative interventions for managing urinary incontinence after prostate surgery. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD014799. doi: 10.1002/14651858.CD014799.pub2.

Reference Type: DERIVED

PMID: 37070660 (View on PubMed)

Other Identifiers

DK60044 (completed)

Identifier Type: -

Identifier Source: org_study_id