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

Urge Urinary Incontinence Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urge Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Urge

• NCT number: NCT00498888
• Study type: Interventional
• Source: Assuta Hospital Systems
• Status: Completed
• Phase: N/A
• Start date: June 2007
• Completion date: November 2012