NCT00498888

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: Assuta Hospital Systems · Academic / Other
• Sex: Female
• Age: 45 Years – 75 Years
• Healthy volunteers: Accepted

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

Conditions

• Urge Urinary Incontinence

Interventions

Type	Name	Description
PROCEDURE	tolterodine	Detrusitol SR 4 mg, 1 capsule for a day, 3 months.
PROCEDURE	bladder training	Four visits in 3 months with pelvic floor physical therapist, who is trained in the procedure, for educate and schedule voiding regimen.
PROCEDURE	pelvic floor muscle training	Four visits in 3 months with pelvic floor physical therapist, who is trained in the procedure, for reinforced pelvic floor muscles.
PROCEDURE	pelvic 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.

Timeline

• Start date: 2007-06-01
• Primary completion: 2012-01-01
• Completion: 2012-11-01
• First posted: 2007-07-11
• Last updated: 2012-11-29

Locations

1 site across 1 country: Israel