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

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.

Conditions

• Urge Urinary Incontinence

Interventions

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.

Sponsors & Collaborators

• Assuta Hospital Systems

  lead OTHER

Principal Investigators

• Rachel Kafri, MSc PT · Maccabi Healthcare Services, Israel

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

75 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2007-06-30

Primary Completion

2012-01-31

Completion

2012-11-30

Countries

• Israel

Study Locations