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NCT Number: NCT00498888

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

* 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.

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Key information

Conditions

Urge Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Urge Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

45 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rehabilitation and Physical Therapy Center, Maccabi Healthcare Services

Rishon LeZiyyon, 75429, Israel

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tolterodine

Procedure

Detrusitol SR 4 mg, 1 capsule for a day, 3 months.

bladder training

Procedure

Four visits in 3 months with pelvic floor physical therapist, who is trained in the procedure, for educate and schedule voiding regimen.

pelvic floor muscle training

Procedure

Four visits in 3 months with pelvic floor physical therapist, who is trained in the procedure, for reinforced pelvic floor muscles.

pelvic floor rehabilitation

Procedure

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.

Primary outcomes

  1. Number of micturitions in a 24 hour bladder diary and number of urge urinary incontinence episodes by subjects' reports per week.

    Time frame: Phase I, II, and III

Secondary outcomes

  1. cost-effectiveness

    Time frame: 1 year

  2. Health service utilization

    Time frame: 1 year

  3. underclothing pad use

    Time frame: Phase I, II, and III

  4. change in physical activity and smoking

    Time frame: Phase I, II, and III

  5. missed days at work

    Time frame: 1 year

  6. Maximum voided volume, as obtained from 24 hours bladder diary

    Time frame: Phase I, II, III

  7. 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

    Time frame: Phase I, II, and III

  8. quality of life measured by I-QoL

    Time frame: Phase I, II, and III

  9. visual analogue scale (VAS) use in urogynecological research

    Time frame: Phase I, II, and III

  10. Incontinence Severity Index (ISI)

    Time frame: Phase I, II, and III

  11. functional status as measured by Late Life Function and Disability Instrument

    Time frame: Phase I, II, and III

  12. Depression status as measured by Center for Epidemiological Studies Depression scale (CES-D)

    Time frame: Phase I, II, and III

  13. Cost benefit

    Time frame: 1 year

  14. Maximum voluntary contraction fo pelvic floor muscle, graded 1-5 by Oxford scale

    Time frame: Phase I, II, and III

Sponsors and collaborators

Lead sponsor

Assuta Hospital Systems

Other

Registry information

Official study 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

Acronym: UUI

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Jul 11, 2007
Registry last updated
Nov 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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