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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
rachel kafri, Assuta Hospital Systems
ClinicalTrials.gov Identifier:
NCT00498888
First received: July 10, 2007
Last updated: November 28, 2012
Last verified: November 2012
  Purpose
  • Urinary Urge Incontinence (UUI) is the involuntary urine loss associated with a strong sensation to void.
  • UUI usually associated with reduced bladder capacity.
  • The pathophysiology is unclear.
  • 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 three issues:

    1. The long term efficacy and cost-effectiveness of the various treatment options.
    2. To identify the factors involved in determining the effectiveness of drug or behavioral therapy.
    3. 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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Assuta Hospital Systems:

Primary Outcome Measures:
  • Number of micturitions in a 24 hour bladder diary and number of urge urinary incontinence episodes by subjects' reports per week. [ Time Frame: Phase I, II, and III ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cost-effectiveness [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Health service utilization [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • underclothing pad use [ Time Frame: Phase I, II, and III ] [ Designated as safety issue: No ]
  • change in physical activity and smoking [ Time Frame: Phase I, II, and III ] [ Designated as safety issue: No ]
  • missed days at work [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Maximum voided volume, as obtained from 24 hours bladder diary [ Time Frame: Phase I, II, III ] [ Designated as safety issue: No ]
  • side effects from list of 10 possible effects: dry mouth, constipation, 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 ] [ Designated as safety issue: No ]
  • quality of life measured by I-QoL [ Time Frame: Phase I, II, and III ] [ Designated as safety issue: No ]
  • visual analogue scale (VAS) use in urogynecological research [ Time Frame: Phase I, II, and III ] [ Designated as safety issue: No ]
  • Incontinence Severity Index (ISI) [ Time Frame: Phase I, II, and III ] [ Designated as safety issue: No ]
  • functional status as measured by Late Life Function and Disability Instrument [ Time Frame: Phase I, II, and III ] [ Designated as safety issue: No ]
  • Depression status as measured by Center for Epidemiological Studies Depression scale (CES-D) [ Time Frame: Phase I, II, and III ] [ Designated as safety issue: No ]
  • Cost benefit [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Maximum voluntary contraction fo pelvic floor muscle, graded 1-5 by Oxford scale [ Time Frame: Phase I, II, and III ] [ Designated as safety issue: No ]

Enrollment: 164
Study Start Date: June 2007
Study Completion Date: November 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Women were prescribed a 3 month supply of Tolterodine SR 4 mg (Detrusitol SR 4 mg, Pfizer Pharmaceuticals Israel LTD) . After the randomization she needs to get the first prescription from her doctor, and followed this protocol every three weeks. Her doctor how already knows this research were explained how to take the drug. After finished this protocol she get the money she pay after sending the receipts and the empty boxes.
Procedure: tolterodine
Detrusitol SR 4 mg, 1 capsule for a day, 3 months.
Active Comparator: 2
The Bladder training protocol aims o to increase the time interval between voids, either by a mandatory or self-adjustable schedule, so that incontinence is ultimately avoided and continence regained. It is generally comprised of three components: 1) patient education that includes information about bladder and how continence is usually maintained, 2) scheduled voiding- a 'timetable for voiding' which may fixed or flexible to suit the participant's rate of increase in interval between voids, commonly the aim is to achieve an interval of three to four hours between voids and 3) positive reinforcement- - psychological support and encouragement is generally considered important and usually provided by health care professional . Frequency volume chart (FVC) records the time and volumes of voided for 24 hours by the women between the appointments. Four visits in 3 months with pelvic floor physical therapist, who is trained in the procedure, for educate and schedule voiding regimen.
Procedure: bladder training
Four visits in 3 months with pelvic floor physical therapist, who is trained in the procedure, for educate and schedule voiding regimen.
Active Comparator: 3
The Pelvic floor muscle training (PFMT) protocol based on National Institute for health and clinical excellence (NICE clinical guideline 40, 2006), that the PFMT programs should comprise at least eight contractions performed three times per day, and the trial of supervised PFMT of at least 3 months' duration . Each appointment the women maid three sets of eight to 12 slow maximal contractions sustained for 6-8 second, and asked to made this protocol every day, and taught to contract these muscle to suppress urge filling. Four visits in 3 months with pelvic floor physical therapist, who is trained in the procedure, for reinforced pelvic floor muscles.
Procedure: pelvic floor muscle training
Four visits in 3 months with pelvic floor physical therapist, who is trained in the procedure, for reinforced pelvic floor muscles.
Active Comparator: 4
Four visits in 3 months with pelvic floor physical therapist, who is trained in the procedure, for pelvic floor muscle training and bladder training and lifestyle advice and information about good bladder and bowel habits.
Procedure: pelvic floor rehabilitation
The Pelvic floor rehabilitation protocol based on bladder training protocol and PFMT and lifestyle advice and information about good bladder and bowel habits. Four visits in 3 months was made with pelvic floor physical therapist, who is trained in the procedure.

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:   45 Years to 75 Years
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
  • unstable diabetes
  • neurological or psychiatric disease
  • narrow angle glaucoma
  • after colposuspension or sling surgery
  • Mini Mental State Examination <24
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Israel
Rehabilitation and Physical Therapy Center, Maccabi Healthcare Services
Rishon Le Zion, Israel, 75429
Sponsors and Collaborators
Assuta Hospital Systems
Investigators
Principal Investigator: Rachel Kafri, MSc PT Maccabi Healthcare Services, Israel
  More Information

No publications provided

Responsible Party: rachel kafri, Maccabi Healthcare Services, Assuta Hospital Systems
ClinicalTrials.gov Identifier: NCT00498888     History of Changes
Other Study ID Numbers: 2007030
Study First Received: July 10, 2007
Last Updated: November 28, 2012
Health Authority: Israel: Ministry of Health

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

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Urge
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Tolterodine
Cholinergic Antagonists
Muscarinic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 01, 2014