The Long Term Outcomes of Rehabilitation and Drug Treatment for in Urgency Urinary Incontinence (UUI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00498888|
Recruitment Status : Completed
First Posted : July 11, 2007
Last Update Posted : November 29, 2012
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Urge Urinary Incontinence||Procedure: tolterodine Procedure: bladder training Procedure: pelvic floor muscle training Procedure: pelvic floor rehabilitation||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||164 participants|
|Intervention Model:||Parallel Assignment|
|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 Start Date :||June 2007|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||November 2012|
Active Comparator: 1
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.
Detrusitol SR 4 mg, 1 capsule for a day, 3 months.
Active Comparator: 2
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.
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.
Active Comparator: 3
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.
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.
Active Comparator: 4
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.
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.
- 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 ]
- cost-effectiveness [ Time Frame: 1 year ]
- Health service utilization [ Time Frame: 1 year ]
- underclothing pad use [ Time Frame: Phase I, II, and III ]
- change in physical activity and smoking [ Time Frame: Phase I, II, and III ]
- missed days at work [ Time Frame: 1 year ]
- Maximum voided volume, as obtained from 24 hours bladder diary [ Time Frame: Phase I, II, III ]
- 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 ]
- quality of life measured by I-QoL [ Time Frame: Phase I, II, and III ]
- visual analogue scale (VAS) use in urogynecological research [ Time Frame: Phase I, II, and III ]
- Incontinence Severity Index (ISI) [ Time Frame: Phase I, II, and III ]
- functional status as measured by Late Life Function and Disability Instrument [ Time Frame: Phase I, II, and III ]
- Depression status as measured by Center for Epidemiological Studies Depression scale (CES-D) [ Time Frame: Phase I, II, and III ]
- Cost benefit [ Time Frame: 1 year ]
- Maximum voluntary contraction fo pelvic floor muscle, graded 1-5 by Oxford scale [ Time Frame: Phase I, II, and III ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00498888
|Rehabilitation and Physical Therapy Center, Maccabi Healthcare Services|
|Rishon Le Zion, Israel, 75429|
|Principal Investigator:||Rachel Kafri, MSc PT||Maccabi Healthcare Services, Israel|