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

Urge Urinary Incontinence Clinical Trial

— UUI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00498888
• Other study ID #: 2007030
• Status: Completed
• Phase: N/A
• First received: July 10, 2007
• Last updated: November 28, 2012
• Start date: June 2007
• Est. completion date: November 2012

Study information

• Verified date: November 2012
• Source: Assuta Hospital Systems
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: November 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 75 Years

Eligibility

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

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

Intervention

Procedure:
• tolterodine
Detrusitol SR 4 mg, 1 capsule for a day, 3 months.
• bladder training
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
Four visits in 3 months with pelvic floor physical therapist, who is trained in the procedure, for reinforced pelvic floor muscles.
• 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.

Locations

Country	Name	City	State
Israel	Rehabilitation and Physical Therapy Center, Maccabi Healthcare Services	Rishon Le Zion

Sponsors (1)

Lead Sponsor	Collaborator
Assuta Hospital Systems

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of micturitions in a 24 hour bladder diary and number of urge urinary incontinence episodes by subjects' reports per week.		Phase I, II, and III	No
Secondary	cost-effectiveness		1 year	No
Secondary	Health service utilization		1 year	No
Secondary	underclothing pad use		Phase I, II, and III	No
Secondary	change in physical activity and smoking		Phase I, II, and III	No
Secondary	missed days at work		1 year	No
Secondary	Maximum voided volume, as obtained from 24 hours bladder diary		Phase I, II, III	No
Secondary	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		Phase I, II, and III	No
Secondary	quality of life measured by I-QoL		Phase I, II, and III	No
Secondary	visual analogue scale (VAS) use in urogynecological research		Phase I, II, and III	No
Secondary	Incontinence Severity Index (ISI)		Phase I, II, and III	No
Secondary	functional status as measured by Late Life Function and Disability Instrument		Phase I, II, and III	No
Secondary	Depression status as measured by Center for Epidemiological Studies Depression scale (CES-D)		Phase I, II, and III	No
Secondary	Cost benefit		1 year	No
Secondary	Maximum voluntary contraction fo pelvic floor muscle, graded 1-5 by Oxford scale		Phase I, II, and III	No