Urge Urinary IncontinenceUUINCT00498888
The Long Term Outcomes of Rehabilitation and Drug Treatment for in Urgency Urinary Incontinence
A study testing tolterodine, bladder training and pelvic floor muscle training in people with Urge Urinary Incontinence, run by Assuta Hospital Systems at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 45 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urge Urinary Incontinence
- What is being tested?
- tolterodine, bladder training and pelvic floor muscle training
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2007to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- complaints of urinary leakage > 3 in last month (not stress incontinence)
- functionally independent subjects
Who cannot join
- urinary tract infection
- urogenital prolapse
- unstable diabetes
- neurological or psychiatric disease
- narrow angle glaucoma
- after colposuspension or sling surgery
- Mini Mental State Examination <24
Trial locations and contacts
1 site in 1 country.
Israel1 site
Rehabilitation and Physical Therapy Center, Maccabi Healthcare Services
Rishon LeZiyyon, 75429
About this study
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
- 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.
Read more
- 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.
Read the 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
- Being tested
- tolterodine, bladder training, pelvic floor muscle training, pelvic floor rehabilitation
- Keywords
- urge urinary incontinence, rehabilitation, anticholinergic
- Medical subject headings
- Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tolterodineProcedure or surgery
Detrusitol SR 4 mg, 1 capsule for a day, 3 months.
bladder trainingProcedure or surgery
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 trainingProcedure or surgery
Four visits in 3 months with pelvic floor physical therapist, who is trained in the procedure, for reinforced pelvic floor muscles.
pelvic floor rehabilitationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 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. Receives: Procedure: tolterodine |
| 2 | Active comparator | 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. Receives: Procedure: bladder training |
| 3 | Active comparator | 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. Receives: Procedure: pelvic floor muscle training |
| 4 | Active comparator | 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. Receives: Procedure: pelvic floor rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of micturitions in a 24 hour bladder diary and number of urge urinary incontinence episodes by subjects' reports per week.
Measured: Phase I, II, and III
Secondary outcomes (14)
cost-effectiveness
Measured: 1 year
Health service utilization
Measured: 1 year
underclothing pad use
Measured: Phase I, II, and III
change in physical activity and smoking
Measured: Phase I, II, and III
missed days at work
Measured: 1 year
Maximum voided volume, as obtained from 24 hours bladder diary
Measured: 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
Measured: Phase I, II, and III
quality of life measured by I-QoL
Measured: Phase I, II, and III
visual analogue scale (VAS) use in urogynecological research
Measured: Phase I, II, and III
Incontinence Severity Index (ISI)
Measured: Phase I, II, and III
functional status as measured by Late Life Function and Disability Instrument
Measured: Phase I, II, and III
Depression status as measured by Center for Epidemiological Studies Depression scale (CES-D)
Measured: Phase I, II, and III
Cost benefit
Measured: 1 year
Maximum voluntary contraction fo pelvic floor muscle, graded 1-5 by Oxford scale
Measured: Phase I, II, and III
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2007 (estimated)
- Study startJun 2007
- Primary completionJan 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urge Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assuta Hospital Systems
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rachel kafri, Assuta Hospital Systems
- Investigators
- Rachel Kafri, MSc PT, Principal investigator, Maccabi Healthcare Services, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00498888
- Sponsor's protocol ID
- 2007030
- Acronym
- UUI
- Status last verified
- Nov 2012
- First submitted
- 10 Jul 2007
- Last updated
- 29 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Funada S, Yoshioka T, Luo Y, Sato A, Akamatsu S, Watanabe N. Bladder training for treating overactive bladder in adults. Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD013571. doi: 10.1002/14651858.CD013571.pub2.
PubMed 37811598
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00498888
- Acronym / sponsor ID
- UUI / 2007030
- Conditions
- Urge Urinary Incontinence
- Keywords
- urge urinary incontinence, rehabilitation, anticholinergic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Assuta Hospital SystemsUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Jan 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 11 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: tolterodineWomen 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. |
| 2 | Active comparator | Procedure: bladder trainingThe 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. |
| 3 | Active comparator | Procedure: pelvic floor muscle trainingThe 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. |
| 4 | Active comparator | Procedure: pelvic floor rehabilitationFour 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. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- complaints of urinary leakage > 3 in last month (not stress incontinence)
- functionally independent subjects
Key exclusion criteria (7 listed)
- urinary tract infection
- urogenital prolapse
- unstable diabetes
- neurological or psychiatric disease
- narrow angle glaucoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tolterodineDetrusitol SR 4 mg, 1 capsule for a day, 3 months. | Procedure or surgery | 1 |
| bladder trainingFour visits in 3 months with pelvic floor physical therapist, who is trained in the procedure, for educate and schedule voiding regimen. | Procedure or surgery | 2 |
| pelvic floor muscle trainingFour visits in 3 months with pelvic floor physical therapist, who is trained in the procedure, for reinforced pelvic floor muscles. | Procedure or surgery | 3 |
| pelvic floor rehabilitationThe 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. | Procedure or surgery | 4 |
Primary outcome
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
14 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2012.
- Derived from this study: PubMed 37811598Funada S, Yoshioka T, Luo Y, Sato A, Akamatsu S, Watanabe N. Bladder training for treating overactive bladder in adults. Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD013571. doi: 10.1002/14651858.CD013571.pub2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Kafri, MSc PT principal investigator
Maccabi Healthcare Services, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tolterodine, bladder training and pelvic floor muscle training in people with Urge Urinary Incontinence, run by Assuta Hospital Systems at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00498888, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2012.