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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


- 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


- 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:


Health 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


Minimum age: 45 Years. Maximum age: 75 Years. Gender(s): Female.


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

Page last updated: August 23, 2015

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