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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG043383-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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This three-site randomized controlled trial compares the effectiveness and cost-effectiveness of a group-administered behavioral treatment program to no treatment. Women with stress, urgency, or mixed urinary incontinence will be recruited and screened centrally, evaluated clinically at each of three study sites, and random assigned to one of two treatment arms: 1. Group behavioral treatment or 2. No treatment. Group treatment modalities have the potential to reach a larger population of older women with urinary incontinence, not only in the traditional medical settings, but also in community settings. The investigators hypothesize that group behavioral treatment will be more effective than no treatment. The investigators hypothesize that the group treatment will be cost-effective compared to no treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Behavioral Treatment | Experimental | Participants will attend a group behavioral treatment class and follow-up visits. |
|
| No Treatment | No Intervention | Subjects will not attend group behavioral treatment class. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group Behavioral Treatment | Behavioral | Group Behavioral Treatment class is a two hour class taught by certified interventionist covering urinary system anatomy, bladder health and self management strategies, pelvic floor training, pelvic floor muscle contracting techniques, and bladder training. Slides and handouts supplement the content of the class. |
| Measure | Description | Time Frame |
|---|---|---|
| Group Behavioral Treatment Effectiveness as Shown by Changes From Baseline to 3 Months in Urinary Incontinence Severity. | The primary outcome is the self-reported urinary incontinence severity as measured by the International Consultation on Incontinence questionnaire-short form (ICI-Q). This short and simple questionnaire is used to screen for incontinence (urine leakage) to obtain a brief yet comprehensive summary of the level, impact and perceived cause of symptoms of incontinence. The ICI-Q consists of four questions and numeric scales: 1. How much do you leak urine? (0-5); never - all the time, 2. How much urine do you usually leak? (0-6); none - large amount, 3. Overall, how much does leaking urine interfere with your everyday life? (0-10); not at all - a great deal, 4. When does urine leak? Multiple choices. The ICI-Q score is the sum of questions 1-3 and ranges from 0-21. The higher the score, the greater severity of incontinence. Baseline data is compared to the 3 month data for the primary outcome. | Baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Group Behavioral Treatment Cost-effectiveness | Measure resource use and utilities and compare the difference in incontinence management costs and utilities between treatment and control group. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
History of renal, bladder, uterine, ovarian, urethral, anal or rectal cancer, radiation therapy to the pelvis for any cancer/malignancy, or any active cancer/malignancy (except skin cancer)
Non-ambulatory (participant confined to bed or wheelchair)
Persistent pelvic pain (defined as daily pelvic pain > 3 months)
History of neurologic or end-stage diseases (e.g. cerebral vascular accident (CVA), Parkinson's disease, multiple sclerosis, epilepsy, spinal cord tumor or trauma, spina bifida, symptomatic herniated disc)
Previous treatment or current participation in a research study for UI, including surgery or formal behavioral treatment (pelvic floor muscle training, biofeedback, pelvic floor electrical stimulation, percutaneous tibial nerve stimulation, sacral neuromodulation, botox or other periurethral injection)
Currently taking urinary incontinence or overactive bladder medications
History of other urinary conditions or procedures that may affect continence status (e.g. urethral diverticula, previous augmentation cystoplasty or artificial urinary sphincter; implanted nerve stimulators for urinary symptoms)
Participation in any drug/device research study.
Pelvic organ prolapse protruding past the introitus (at rest or persisting after strain)
Evidence of urinary tract infection (UTI) by urine dipstick (leukocytes +1 or greater, nitrites +1 or greater, leukocytes alone (w/o nitrites) +2 or greater, or presence of hematuria > +1). Participants may be re-screened after treatment with antibiotics or if hematuria work-up is negative.
History of 2 or more recurrent UTI's within the past year; more than one UTI within past 6 months
Post void residual urine volume 150 cc or more.
Unstable medical condition (as determined by site PI)
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| Name | Affiliation | Role |
|---|---|---|
| Ananias C Diokno, MD | Corewell Health East | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham VA Medical Cnter | Birmingham | Alabama | 35233 | United States | ||
| University of Michigan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37811598 | Derived | 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. | |
| 30193294 | Derived | Diokno AC, Newman DK, Low LK, Griebling TL, Maddens ME, Goode PS, Raghunathan TE, Subak LL, Sampselle CM, Boura JA, Robinson AE, McIntyre D, Burgio KL. Effect of Group-Administered Behavioral Treatment on Urinary Incontinence in Older Women: A Randomized Clinical Trial. JAMA Intern Med. 2018 Oct 1;178(10):1333-1341. doi: 10.1001/jamainternmed.2018.3766. |
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Recruitment letters were mailed to women 55 years and older seeking women with urinary incontinence who were treatment naïve. Those that met preliminary screening criteria, done at the administrative site, were referred to one of the three clinical sites (Alabama, Michigan or Pennsylvania) for final screening and enrollment .
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| ID | Title | Description |
|---|---|---|
| FG000 | Group Behavioral Treatment | Participants will attend a group behavioral treatment class and follow-up visits. Group Behavioral Treatment: Group Behavioral Treatment class is a two hour class taught by certified interventionist covering urinary system anatomy, bladder health and self management strategies, pelvic floor training, pelvic floor muscle contracting techniques, and bladder training. Slides and handouts supplement the content of the class. |
| FG001 | No Treatment | Subjects will not attend group behavioral treatment class but have the same follow-up visit schedule. Subjects will receive the same handout. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group Behavioral Treatment | Participants will attend a group behavioral treatment class and follow-up visits. Group Behavioral Treatment: Group Behavioral Treatment class is a two hour class taught by certified interventionist covering urinary system anatomy, bladder health and self management strategies, pelvic floor training, pelvic floor muscle contracting techniques, and bladder training. Slides and handouts supplement the content of the class. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Group Behavioral Treatment Effectiveness as Shown by Changes From Baseline to 3 Months in Urinary Incontinence Severity. | The primary outcome is the self-reported urinary incontinence severity as measured by the International Consultation on Incontinence questionnaire-short form (ICI-Q). This short and simple questionnaire is used to screen for incontinence (urine leakage) to obtain a brief yet comprehensive summary of the level, impact and perceived cause of symptoms of incontinence. The ICI-Q consists of four questions and numeric scales: 1. How much do you leak urine? (0-5); never - all the time, 2. How much urine do you usually leak? (0-6); none - large amount, 3. Overall, how much does leaking urine interfere with your everyday life? (0-10); not at all - a great deal, 4. When does urine leak? Multiple choices. The ICI-Q score is the sum of questions 1-3 and ranges from 0-21. The higher the score, the greater severity of incontinence. Baseline data is compared to the 3 month data for the primary outcome. | The Group Behavioral Treatment group population at baseline is 232. At the 3 month follow-up visit 16 had withdrawn and 7 missed the appointment, leaving 209 for the total number analyzed. For the No Treatment group, the number at baseline is 231 and by the 3 month visit 8 had withdrawn and another 11 missed the appointment, leaving 212. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline and 3 months |
Adverse event data was collected from enrollment through the one year follow-up visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group Behavioral Treatment | Participants will attend a group behavioral treatment class and follow-up visits. Group Behavioral Treatment: Group Behavioral Treatment class is a two hour class taught by certified interventionist covering urinary system anatomy, bladder health and self management strategies, pelvic floor training, pelvic floor muscle contracting techniques, and bladder training. Slides and handouts supplement the content of the class. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ananias C. Diokno, MD | Beaumont Health | ananias.diokno@beaumont.edu |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| D053202 | Urinary Incontinence, Urge |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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The randomization schedule will be concealed so that investigators and staff at the sites will not be able to anticipate experimental group assignments. Evaluators at each site will be blind to group assignment throughout all assessments.
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| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| University of Pennsylvania Health System, Urology | Philadelphia | Pennsylvania | 19104 | United States |
| BG001 | No Treatment | Subjects will not attend group behavioral treatment class but have the same follow-up visit schedule. Subjects will receive the same handout. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Secondary | Group Behavioral Treatment Cost-effectiveness | Measure resource use and utilities and compare the difference in incontinence management costs and utilities between treatment and control group. | Not Posted | 12 months | Participants |
| 1 |
| 232 |
| 5 |
| 232 |
| EG001 | No Treatment | Subjects will not attend group behavioral treatment class but have the same follow-up visit schedule. Subjects will receive the same handout. | 0 | 231 | 6 | 231 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |