Conservative Treatment of Postprostatectomy Incontinence

NCT00212264 | Completed Results

• 1 other identifier: DK60044 (completed)
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence

Keywords

urinary incontinence; therapy; prostatectomy; prostate cancer

Outcome Measures

Primary Outcomes (2)

• Percent Change in Incontinence Episodes on Bladder Diary

  \[(Baseline incontinence episodes minus 2-month incontinence episodes)/baseline incontinence episodes\] x 100%

  2 months

• Percent Change in Incontinence Episodes Per Week on Bladder Diary

  \[(Baseline incontinence episodes minus 12-month incontinence episodes)/baseline incontinence episodes\] x 100%

  1 year

Study Arms (3)

Behavioral Therapy

EXPERIMENTAL

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

Behavioral: Behavioral Therapy

Behavioral Therapy Plus Technologies

EXPERIMENTAL

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

Behavioral: Behavioral Therapy; Device: Pelvic Floor Electrical Stimulation; Behavioral: Biofeedback

Placebo Comparator

PLACEBO COMPARATOR

No treatment control

Other: No Treatment

Interventions

Behavioral Therapy BEHAVIORAL

Pelvic Floor Muscle Exercises and Bladder control strategies

Behavioral Therapy; Behavioral Therapy Plus Technologies

Pelvic Floor Electrical Stimulation DEVICE

Pelvic Floor Electrical Stimulation daily for 8 weeks

Behavioral Therapy Plus Technologies

Biofeedback BEHAVIORAL

Pelvic Floor Muscle training via biofeedback

Behavioral Therapy Plus Technologies

No Treatment OTHER

No treatment

Placebo Comparator

Eligibility Criteria

• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Involuntary loss of urine that started immediately after radical prostatectomy and has persisted for at least one year.
• One-week bladder diary with interpretable data and at least two incontinence episodes

You may not qualify if:

• Any unstable medical condition, particularly decompensated congestive heart failure, history of malignant arrhythmias, or unstable angina
• Cardiac pacemaker or implanted cardiac defibrillator
• Current use of anticholinergic agents for detrusor instability
• Folstein's Mini-Mental State Exam score below 24 (impaired mental status)
• One-week bladder diary with continual leakage - defined as always being damp or wet or unable to quantitate individual accidents.
• Poorly controlled diabetes, defined as (glycosylated hemoglobin \> 9 within last 3 months).
• Hematuria on microscopic examination. Enrollment will be permitted after urologic evaluation.
• Urodynamic evaluation: Post-void residual volume greater than 200 mL

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (2)

• 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.

  PMID: 21224456 RESULT

• 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.

  PMID: 37070660 DERIVED

MeSH Terms

Conditions

Urinary Incontinence; Prostatic Neoplasms

Interventions

Behavior Therapy; Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Prostatic Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Mind-Body Therapies; Complementary Therapies; Therapeutics; Feedback, Psychological

Results Point of Contact

• Title: Patricia S Goode, MD
• Organization: University of Alabama at Birmingham

pgoode@uabmc.edu

2055587064

Study Officials

• Patricia S Goode, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: August 1, 2003
• Primary Completion: September 1, 2008
• Study Completion: August 1, 2011
• Last Updated: April 11, 2016
• Results First Posted: April 11, 2016

Record last verified: 2016-03

Locations

US (1)