The Long Term Outcomes of Rehabilitation and Drug Treatment for in Urgency Urinary Incontinence
Information source: Assuta Hospital Systems
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Urge Urinary Incontinence
Intervention: tolterodine (Procedure); bladder training (Procedure); pelvic floor muscle training (Procedure); pelvic floor rehabilitation (Procedure)
Phase: N/A
Status: Completed
Sponsored by: Assuta Hospital Systems Official(s) and/or principal investigator(s): Rachel Kafri, MSc PT, Principal Investigator, Affiliation: Maccabi Healthcare Services, Israel
Summary
- 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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: Number of micturitions in a 24 hour bladder diary and number of urge urinary incontinence episodes by subjects' reports per week.
Secondary outcome: cost-effectivenessHealth service utilization underclothing pad use change in physical activity and smoking missed days at work Maximum voided volume, as obtained from 24 hours bladder diary 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 quality of life measured by I-QoL visual analogue scale (VAS) use in urogynecological research Incontinence Severity Index (ISI) functional status as measured by Late Life Function and Disability Instrument Depression status as measured by Center for Epidemiological Studies Depression scale (CES-D) Cost benefit Maximum voluntary contraction fo pelvic floor muscle, graded 1-5 by Oxford scale
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
Minimum age: 45 Years.
Maximum age: 75 Years.
Gender(s): Female.
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
Locations and Contacts
Rehabilitation and Physical Therapy Center, Maccabi Healthcare Services, Rishon Le Zion 75429, Israel
Additional Information
Starting date: June 2007
Last updated: November 28, 2012
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