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

Primary Purpose

Urge Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
tolterodine
bladder training
pelvic floor muscle training
pelvic floor rehabilitation
Sponsored by
Assuta Hospital Systems
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urge Urinary Incontinence focused on measuring urge urinary incontinence, rehabilitation, anticholinergic

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Rehabilitation and Physical Therapy Center, Maccabi Healthcare Services

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

4

Arm Description

Women were prescribed a 3 month supply of Tolterodine SR 4 mg (Detrusitol SR 4 mg, Pfizer Pharmaceuticals Israel LTD) . After the randomization she needs to get the first prescription from her doctor, and followed this protocol every three weeks. Her doctor how already knows this research were explained how to take the drug. After finished this protocol she get the money she pay after sending the receipts and the empty boxes.

The Bladder training protocol aims o to increase the time interval between voids, either by a mandatory or self-adjustable schedule, so that incontinence is ultimately avoided and continence regained. It is generally comprised of three components: 1) patient education that includes information about bladder and how continence is usually maintained, 2) scheduled voiding- a 'timetable for voiding' which may fixed or flexible to suit the participant's rate of increase in interval between voids, commonly the aim is to achieve an interval of three to four hours between voids and 3) positive reinforcement- - psychological support and encouragement is generally considered important and usually provided by health care professional . Frequency volume chart (FVC) records the time and volumes of voided for 24 hours by the women between the appointments. Four visits in 3 months with pelvic floor physical therapist, who is trained in the procedure, for educate and schedule voiding regimen.

The Pelvic floor muscle training (PFMT) protocol based on National Institute for health and clinical excellence (NICE clinical guideline 40, 2006), that the PFMT programs should comprise at least eight contractions performed three times per day, and the trial of supervised PFMT of at least 3 months' duration . Each appointment the women maid three sets of eight to 12 slow maximal contractions sustained for 6-8 second, and asked to made this protocol every day, and taught to contract these muscle to suppress urge filling. Four visits in 3 months with pelvic floor physical therapist, who is trained in the procedure, for reinforced pelvic floor muscles.

Four visits in 3 months with pelvic floor physical therapist, who is trained in the procedure, for pelvic floor muscle training and bladder training and lifestyle advice and information about good bladder and bowel habits.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

cost-effectiveness
Health service utilization
underclothing pad use
change in physical activity and smoking
missed days at work
Maximum voided volume, as obtained from 24 hours bladder diary
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
quality of life measured by I-QoL
visual analogue scale (VAS) use in urogynecological research
Incontinence Severity Index (ISI)
functional status as measured by Late Life Function and Disability Instrument
Depression status as measured by Center for Epidemiological Studies Depression scale (CES-D)
Cost benefit
Maximum voluntary contraction fo pelvic floor muscle, graded 1-5 by Oxford scale

Full Information

First Posted
July 10, 2007
Last Updated
November 28, 2012
Sponsor
Assuta Hospital Systems
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1. Study Identification

Unique Protocol Identification Number
NCT00498888
Brief Title
The Long Term Outcomes of Rehabilitation and Drug Treatment for in Urgency Urinary Incontinence
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assuta Hospital Systems

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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): Pelvic Floor Rehabilitation (includes muscle training+behavioral intervention+bladder training) Pelvic Floor muscle training alone Bladder Training alone Drug treatment with Tolterodine. Study variables will include: impairment ratings, quality of life, and cost-effectiveness. This study addresses three issues: The long term efficacy and cost-effectiveness of the various treatment options. To identify the factors involved in determining the effectiveness of drug or behavioral therapy. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urge Urinary Incontinence
Keywords
urge urinary incontinence, rehabilitation, anticholinergic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
164 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Women were prescribed a 3 month supply of Tolterodine SR 4 mg (Detrusitol SR 4 mg, Pfizer Pharmaceuticals Israel LTD) . After the randomization she needs to get the first prescription from her doctor, and followed this protocol every three weeks. Her doctor how already knows this research were explained how to take the drug. After finished this protocol she get the money she pay after sending the receipts and the empty boxes.
Arm Title
2
Arm Type
Active Comparator
Arm Description
The Bladder training protocol aims o to increase the time interval between voids, either by a mandatory or self-adjustable schedule, so that incontinence is ultimately avoided and continence regained. It is generally comprised of three components: 1) patient education that includes information about bladder and how continence is usually maintained, 2) scheduled voiding- a 'timetable for voiding' which may fixed or flexible to suit the participant's rate of increase in interval between voids, commonly the aim is to achieve an interval of three to four hours between voids and 3) positive reinforcement- - psychological support and encouragement is generally considered important and usually provided by health care professional . Frequency volume chart (FVC) records the time and volumes of voided for 24 hours by the women between the appointments. Four visits in 3 months with pelvic floor physical therapist, who is trained in the procedure, for educate and schedule voiding regimen.
Arm Title
3
Arm Type
Active Comparator
Arm Description
The Pelvic floor muscle training (PFMT) protocol based on National Institute for health and clinical excellence (NICE clinical guideline 40, 2006), that the PFMT programs should comprise at least eight contractions performed three times per day, and the trial of supervised PFMT of at least 3 months' duration . Each appointment the women maid three sets of eight to 12 slow maximal contractions sustained for 6-8 second, and asked to made this protocol every day, and taught to contract these muscle to suppress urge filling. Four visits in 3 months with pelvic floor physical therapist, who is trained in the procedure, for reinforced pelvic floor muscles.
Arm Title
4
Arm Type
Active Comparator
Arm Description
Four visits in 3 months with pelvic floor physical therapist, who is trained in the procedure, for pelvic floor muscle training and bladder training and lifestyle advice and information about good bladder and bowel habits.
Intervention Type
Procedure
Intervention Name(s)
tolterodine
Intervention Description
Detrusitol SR 4 mg, 1 capsule for a day, 3 months.
Intervention Type
Procedure
Intervention Name(s)
bladder training
Intervention Description
Four visits in 3 months with pelvic floor physical therapist, who is trained in the procedure, for educate and schedule voiding regimen.
Intervention Type
Procedure
Intervention Name(s)
pelvic floor muscle training
Intervention Description
Four visits in 3 months with pelvic floor physical therapist, who is trained in the procedure, for reinforced pelvic floor muscles.
Intervention Type
Procedure
Intervention Name(s)
pelvic floor rehabilitation
Intervention Description
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 Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
cost-effectiveness
Time Frame
1 year
Title
Health service utilization
Time Frame
1 year
Title
underclothing pad use
Time Frame
Phase I, II, and III
Title
change in physical activity and smoking
Time Frame
Phase I, II, and III
Title
missed days at work
Time Frame
1 year
Title
Maximum voided volume, as obtained from 24 hours bladder diary
Time Frame
Phase I, II, III
Title
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
Title
quality of life measured by I-QoL
Time Frame
Phase I, II, and III
Title
visual analogue scale (VAS) use in urogynecological research
Time Frame
Phase I, II, and III
Title
Incontinence Severity Index (ISI)
Time Frame
Phase I, II, and III
Title
functional status as measured by Late Life Function and Disability Instrument
Time Frame
Phase I, II, and III
Title
Depression status as measured by Center for Epidemiological Studies Depression scale (CES-D)
Time Frame
Phase I, II, and III
Title
Cost benefit
Time Frame
1 year
Title
Maximum voluntary contraction fo pelvic floor muscle, graded 1-5 by Oxford scale
Time Frame
Phase I, II, and III

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Kafri, MSc PT
Organizational Affiliation
Maccabi Healthcare Services, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehabilitation and Physical Therapy Center, Maccabi Healthcare Services
City
Rishon Le Zion
ZIP/Postal Code
75429
Country
Israel

12. IPD Sharing Statement

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

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