Urinary Incontinence, Stress, Urinary Incontinence, Urge
Conditions
Brief summary
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.
Interventions
BEHAVIORALGroup 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.
Sponsors
National Institute on Aging (NIA)
Ananias Diokno
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
FEMALE
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Female 2. Aged 55 years or older 3. Ability to understand, read and write English 4. Stress, urgency, or mixed urgency and stress urinary incontinence (UI) (by self report) 5. On the International Consultation on Incontinence Modular Questionnaire - Short Form (ICIQ UI-SF), frequency of leakage at least a 1 (about once a week or less often) on item #1 and volume of urine loss at least a 2 (a small amount) on item #2. 6. Symptoms of three months duration or longer (on history) 7. Passing score (i.e., categorized as probably not demented) on the MiniCog Test 8. Timed Up and Go Test (TUG) score of 20 seconds or less 9. Willing to undergo vaginal/pelvic examination 10. Signed informed consent form
Exclusion criteria
1. 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) 2. Non-ambulatory (participant confined to bed or wheelchair) 3. Persistent pelvic pain (defined as daily pelvic pain \> 3 months) 4. 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) 5. 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) 6. Currently taking urinary incontinence or overactive bladder medications 7. 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) 8. Participation in any drug/device research study. 9. Pelvic organ prolapse protruding past the introitus (at rest or persisting after strain) 10. 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. 11. History of 2 or more recurrent UTI's within the past year; more than one UTI within past 6 months 12. Post void residual urine volume 150 cc or more. 13. Unstable medical condition (as determined by site PI) \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Group Behavioral Treatment Effectiveness as Shown by Changes From Baseline to 3 Months in Urinary Incontinence Severity. | Baseline and 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Group Behavioral Treatment Cost-effectiveness | 12 months | Measure resource use and utilities and compare the difference in incontinence management costs and utilities between treatment and control group. |
Countries
United States
Participant flow
Recruitment details
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 .
Participants by arm
| Arm | Count |
|---|---|
| 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. | 232 |
| No Treatment Subjects will not attend group behavioral treatment class but have the same follow-up visit schedule. Subjects will receive the same handout. | 231 |
| Total | 463 |
Baseline characteristics
| Characteristic | Group Behavioral Treatment | No Treatment | Total |
|---|---|---|---|
| Age, Continuous | 64 years STANDARD_DEVIATION 6.8 | 65 years STANDARD_DEVIATION 7.7 | 64 years STANDARD_DEVIATION 7.3 |
| Sex: Female, Male Female | 232 Participants | 231 Participants | 463 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 232 | 6 / 231 |
| serious Total, serious adverse events | 1 / 232 | 0 / 231 |
Outcome results
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.
Time frame: Baseline and 3 months
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group Behavioral Treatment | Group Behavioral Treatment Effectiveness as Shown by Changes From Baseline to 3 Months in Urinary Incontinence Severity. | -2 units on a scale |
| No Treatment | Group Behavioral Treatment Effectiveness as Shown by Changes From Baseline to 3 Months in Urinary Incontinence Severity. | -1 units on a scale |
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.
Time frame: 12 months