Clinical trial NCT00498888: The Long Term Outcomes of Rehabilitation and Drug Treatment for in Urgency Urinary Incontinence
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urge Urinary Incontinence
Keywords: urge urinary incontinence
rehabilitation
anticholinergic
Lead sponsor: Assuta Hospital Systems
Sponsor class: OTHER
First posted: 2007-07-11
Enrollment: 164
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Number of micturitions in a 24 hour bladder diary and number of urge urinary incontinence episodes by subjects' reports per week.
timeFrame: Phase I, II, and III
Secondary outcomes:
measure: cost-effectiveness
timeFrame: 1 year
measure: Health service utilization
timeFrame: 1 year
measure: underclothing pad use
timeFrame: Phase I, II, and III
measure: change in physical activity and smoking
timeFrame: Phase I, II, and III
measure: missed days at work
timeFrame: 1 year
measure: Maximum voided volume, as obtained from 24 hours bladder diary
timeFrame: Phase I, II, III
measure: 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
timeFrame: Phase I, II, and III
measure: quality of life measured by I-QoL
timeFrame: Phase I, II, and III
measure: visual analogue scale (VAS) use in urogynecological research
timeFrame: Phase I, II, and III
measure: Incontinence Severity Index (ISI)
timeFrame: Phase I, II, and III
measure: functional status as measured by Late Life Function and Disability Instrument
timeFrame: Phase I, II, and III
measure: Depression status as measured by Center for Epidemiological Studies Depression scale (CES-D)
timeFrame: Phase I, II, and III
measure: Cost benefit
timeFrame: 1 year
measure: Maximum voluntary contraction fo pelvic floor muscle, graded 1-5 by Oxford scale
timeFrame: Phase I, II, and III
Other outcomes:
Locations:
city: Rishon Le Zion
country: Israel
facility: Rehabilitation and Physical Therapy Center, Maccabi Healthcare Services
Study officials:
affiliation: Maccabi Healthcare Services, Israel
name: Rachel Kafri, MSc PT
role: PRINCIPAL_INVESTIGATOR
References: