Further Enhancing Non-pharmacologic Therapy for Incontinence

NCT00177541 | Completed DMC

• 1 other identifier: 5R01AG020629-02
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the mechanisms mediating the therapeutic efficacy of pelvic floor muscle exercises and biofeedback for urge urinary incontinence, as well as the characteristics of patients most likely to respond. By identifying the key components of this treatment, we hope to simplify it and make it more easily applicable, more effective, less expensive, and thus more useful for people with urge incontinence in the future.

Conditions

Urge Urinary Incontinence

Keywords

urge incontinence; biofeedback; pelvic floor muscle training; behavior modification

Outcome Measures

Primary Outcomes (1)

• Percentage reduction in urge incontinence episodes at 12 weeks

  12 weeks

Secondary Outcomes (4)

• Various urodynamic parameters such as, e.g.:

  12 weeks

• Increase in functional bladder capacity at 12 weeks

  12 weeks

• Volume at first detrusor overactivity at 12 weeks

  12 weeks

• Improvement in QoL at 12 weeks

  12 weeks

Study Arms (1)

Biofeedback

EXPERIMENTAL

Biofeedback assisted pelvic floor muscle therapy (3 visits)

Behavioral: Biofeedback, pelvic floor muscle training, fMRI

Interventions

Biofeedback, pelvic floor muscle training, fMRI BEHAVIORAL

Biofeedback, pelvic floor muscle training, fMRI

Biofeedback

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ambulatory women over age 60, who are incontinent at least twice weekly for 3 months despite correction of potentially reversible causes.
• urinary incontinence (urge or predominantly urge) by clinical criteria.
• able to accurately complete a voiding diary, to perform a 24-hour pad test under direction, and to undergo instruction in biofeedback.

You may not qualify if:

• significant mental impairment \[mini mental status exam (MMSE) ≤ 20)
• urethral obstruction
• history of bladder cancer
• spinal cord lesions
• multiple sclerosis
• pelvic radiation
• interstitial cystitis
• artificial sphincter implant
• expected to have changes in medications/doses during the trial
• medically unstable
• Patients with factors that could cause transient UI \[e.g., current urinary tract infection (UTI), acute confusion\] will be treated in concert with the subject's primary care provider and considered for enrollment if their UI persists.
• conditions that require endocarditis prophylaxis (such as heart valve problems or bacterial endocarditis)
• being unable to undergo fMRI because of claustrophobia or any metallic objects in the body, such pacemakers, metallic prostheses, aneurism clips or others.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Geriatric Continence Research Unit, NE547 Montefiore UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (3)

• Burgio KL, Locher JL, Goode PS, Hardin JM, McDowell BJ, Dombrowski M, Candib D. Behavioral vs drug treatment for urge urinary incontinence in older women: a randomized controlled trial. JAMA. 1998 Dec 16;280(23):1995-2000. doi: 10.1001/jama.280.23.1995.

  PMID: 9863850 BACKGROUND

• Resnick NM. Improving treatment of urinary incontinence. JAMA. 1998 Dec 16;280(23):2034-5. doi: 10.1001/jama.280.23.2034. No abstract available.

  PMID: 9863856 BACKGROUND

• Resnick NM, Perera S, Tadic S, Organist L, Riley MA, Schaefer W, Griffiths D. What predicts and what mediates the response of urge urinary incontinence to biofeedback? Neurourol Urodyn. 2013 Jun;32(5):408-15. doi: 10.1002/nau.22347. Epub 2012 Nov 20.

  PMID: 23168606 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Urge

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Urinary Incontinence; 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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Neil M Resnick, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Becky Clarkson, PhD

  University of Pittsburgh

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: February 1, 2004
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: August 8, 2017

Record last verified: 2017-08

Locations

US (1)