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The Long Term Outcomes of Rehabilitation and Drug Treatment for in Urge Urinary Incontinence (UUI)

This study is currently recruiting participants.
Verified by Assuta Hospital Systems, July 2007

Sponsors and Collaborators: Assuta Hospital Systems
Maccabi Healthcare Services
Information provided by: Assuta Hospital Systems
ClinicalTrials.gov Identifier: NCT00498888
  Purpose

Urinary Urge Incontinence (UUI) is the involuntary urine loss associated with a strong sensation to void, and is usually associated with reduced bladder capacity. The pathophysiology is unclear, but pelvic floor muscle dysfunction and detrusor instability have been suggested as possible mechanisms. Standard treatment includes anticholinergic medication and behavior modification.

The study aims to compare the long term effectiveness of 4 different approaches to the treatment of women with Urge Urinary Incontinence (UUI):

  1. Pelvic Floor Rehabilitation (includes muscle training+behavioral intervention+bladder training)
  2. Pelvic Floor muscle training alone
  3. Bladder Training alone
  4. Drug treatment with Tolterodine. Study variables will include: impairment ratings, quality of life, and cost-effectiveness

This study addresses two issues:

  1. The pathophysiology of UUI. By subdividing the rehabilitation group into 3 arms, we hope to shed light on the mechanism of dysfunction. A better response in one group will help localize the problem to pelvic floor muscles or to detrusor instability.
  2. The long term efficacy and cost-effectiveness of the various treatment options.

Condition Intervention
Urge Urinary Incontinence
 Drug: tolterodine
Procedure: bladder training
Procedure: pelvic floor rehabilitation
Procedure: pelvic floor muscle training

MedlinePlus related topics:   Pelvic Support Problems    Rehabilitation    Urinary Incontinence   

ChemIDplus related topics:   Tolterodine    Tolterodine tartrate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:   Is the a Difference Between Rehabilitation Treatment, Pelvic Floor Muscle Training, Bladder Training and Anticholinergic Drug Treatment in UUI in the Long Term: A Study of Impairment, Quality of Life, and Cost Effectiveness

Further study details as provided by Assuta Hospital Systems:

Primary Outcome Measures:
  • Maximum voided volume, as obtained from 24 hours frequency volume chart (FVC) [ Time Frame: Phase I, II, and III ]
  • Maximum bladder capacity as measured by doppler ultrasound (BladderScan BVI 6100, Verathon) [ Time Frame: Phase I, II, and III ]
  • Daytime and nighttime urinary frequency, as reflected in a 24 hour frequency volume chart (FVC) [ Time Frame: Phase I, II, and III ]
  • Frequency of incontinence episodes by subjects' reports [ Time Frame: Phase I, II, and III ]
  • side effects from list of 10 possible effects: dry mouth, constipation, sleepiness, fatigue, blurred vision, dizziness, urinary difficulty, tachycardia, headache and low back pain [ Time Frame: Phase I, II, and III ]
  • visual analogue scale (VAS) use in urogynecological research [ Time Frame: Phase I, II, and III ]
  • Incontinence Severity Index (ISI) [ Time Frame: Phase I, II, and III ]
  • quality of life measured by I-QoL [ Time Frame: Phase I, II, and III ]
  • functional status as measured by Late Life Function and Disability Instrument [ Time Frame: Phase I, II, and III ]
  • Depression status as measured by CES-D [ Time Frame: Phase I, II, and III ]
  • Cost benefit [ Time Frame: 1 year ]
  • Maximum voluntary contraction fo pelvic floor muscle, graded 1-5 by Oxford scale [ Time Frame: Phase I, II, and III ]

Secondary Outcome Measures:
  • cost-effectiveness [ Time Frame: 1 year ]
  • Health service utilization [ Time Frame: 1 year ]
  • underclothing pad use [ Time Frame: Phase I, II, and III ]
  • change in physical activity and smoking [ Time Frame: Phase I, II, and III ]
  • missed days at work [ Time Frame: 1 year ]

Estimated Enrollment:   180
Study Start Date:   June 2007
Estimated Study Completion Date:   October 2009

Detailed Description:

The study has 3 phases: Before treatment (phase I), immediately after 3 months of treatment (phase II), and 1 year post-entry (phase III)

Women with UUI will be divided randomly into one of the four treatment groups. Every subject will participate in 4 visits. The drug group treatment consists of administration of tolterodine SR 4 mg daily for 3 months. Subjects who assigned to the pelvic floor rehabilitation, pelvic floor muscle training, and bladder training groups will be treated via 4 visits to a physical therapist, who is trained in the procedures. The chief researcher (RK) will be blinded to the treatment groups and will perform the outcome measures in all phases.

Study variables will include impairment ratings, quality of life, and cost-effectiveness

  Eligibility
Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • complaints of urinary leakage > 3 in last month (not stress incontinence)
  • functionally independent subjects

Exclusion Criteria:

  • urinary tract infection
  • urogenital prolapse
  • diabetes mellitus
  • neurological or psychiatric disease
  • narrow angle glaucoma
  • after colposuspension or sling surgery
  • Mini Mental State Examination <24
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00498888

Contacts
Contact: Rachel Kafri, MSc PT     +972-3-9533000     kafri_r@mac.org.il    
Contact: Jeffrey Shames, MD     +972-3-9533000     jshames@gmail.com    

Locations
Israel
Rehabilitation and Physical Therapy Center, Maccabi Healthcare Services     Recruiting
      Rishon Le Zion, Israel, 75429

Sponsors and Collaborators
Assuta Hospital Systems
Maccabi Healthcare Services

Investigators
Principal Investigator:     Rachel Kafri, MSc PT     Maccabi Healthcare Services    
  More Information


Study ID Numbers:   2007030
First Received:   July 10, 2007
Last Updated:   July 10, 2007
ClinicalTrials.gov Identifier:   NCT00498888
Health Authority:   Israel: Ministry of Health

Keywords provided by Assuta Hospital Systems:
urge urinary incontinence  
rehabilitation  
anticholinergic  

Study placed in the following topic categories:
Signs and Symptoms
Urologic Diseases
Urination Disorders
Quality of Life
Urinary Incontinence
Urinary Incontinence, Urge
Tolterodine

Additional relevant MeSH terms:
Muscarinic Antagonists
Urological Manifestations
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Physiological Effects of Drugs
Cholinergic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 06, 2008

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