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

Study Overview
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Brief Summary
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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): Pelvic Floor Rehabilitation (includes muscle training+behavioral intervention+bladder training) Pelvic Floor muscle training alone Bladder Training alone Drug treatment with Tolterodine. Study variables will include: impairment ratings, quality of life, and cost-effectiveness. This study addresses three issues: The long term efficacy and cost-effectiveness of the various treatment options. To identify the factors involved in determining the effectiveness of drug or behavioral therapy. 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.

Detailed Description
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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

Official Title
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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

Conditions
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Urge Urinary Incontinence

Intervention / Treatment
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* Procedure: tolterodine
* Procedure: bladder training
* Procedure: pelvic floor muscle training
* Procedure: pelvic floor rehabilitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>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<br>* Detrusitol SR 4 mg, 1 capsule for a day, 3 months.<br>|
| Active Comparator: 2<br>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<br>* Four visits in 3 months with pelvic floor physical therapist, who is trained in the procedure, for educate and schedule voiding regimen.<br>|
| Active Comparator: 3<br>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<br>* Four visits in 3 months with pelvic floor physical therapist, who is trained in the procedure, for reinforced pelvic floor muscles.<br>|
| Active Comparator: 4<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of micturitions in a 24 hour bladder diary and number of urge urinary incontinence episodes by subjects' reports per week. |  | Phase I, II, and III | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cost-effectiveness |  | 1 year | 
| Health service utilization |  | 1 year | 
| underclothing pad use |  | Phase I, II, and III | 
| change in physical activity and smoking |  | Phase I, II, and III | 
| missed days at work |  | 1 year | 
| Maximum voided volume, as obtained from 24 hours bladder diary |  | Phase I, II, III | 
| 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 |  | Phase I, II, and III | 
| quality of life measured by I-QoL |  | Phase I, II, and III | 
| visual analogue scale (VAS) use in urogynecological research |  | Phase I, II, and III | 
| Incontinence Severity Index (ISI) |  | Phase I, II, and III | 
| functional status as measured by Late Life Function and Disability Instrument |  | Phase I, II, and III | 
| Depression status as measured by Center for Epidemiological Studies Depression scale (CES-D) |  | Phase I, II, and III | 
| Cost benefit |  | 1 year | 
| Maximum voluntary contraction fo pelvic floor muscle, graded 1-5 by Oxford scale |  | Phase I, II, and III | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urge urinary incontinence, rehabilitation, anticholinergic