Urge Urinary Incontinence
Conditions
Keywords
urge urinary incontinence, rehabilitation, anticholinergic
Brief 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.
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
Interventions
PROCEDUREtolterodine
Detrusitol SR 4 mg, 1 capsule for a day, 3 months.
PROCEDUREbladder training
Four visits in 3 months with pelvic floor physical therapist, who is trained in the procedure, for educate and schedule voiding regimen.
PROCEDUREpelvic floor muscle training
Four visits in 3 months with pelvic floor physical therapist, who is trained in the procedure, for reinforced pelvic floor muscles.
PROCEDUREpelvic 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.
Sponsors
Assuta Hospital Systems
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| cost-effectiveness | 1 year |
| 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 |
| quality of life measured by I-QoL | Phase I, II, and III |
Countries
Israel
Outcome results
None listed