Overactive Bladder
Conditions
Keywords
Overactive Bladder, Multimedia, Behavioral Therapy
Brief summary
This study compares the efficacy of embedding avatars into an online self-management program that teaches OAB behavioral therapy on OAB-related quality of life, symptoms, self-efficacy, and adherence versus the same program without avatars
Interventions
OTHERAvatar group
We developed and tested the online program of three multimedia tutorials using the game development and rendering engine (Unity3D, Unity Technologies, San Francisco, CA). This arm saw the tutorials with Avatars.
OTHERNo Avatar group
We developed and tested the online program of three multimedia tutorials using the game development and rendering engine (Unity3D, Unity Technologies, San Francisco, CA). This arm saw the tutorials without Avatars.
Sponsors
Pfizer
Miami VA Healthcare System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age 55 or older * women living in the community * who could read and speak English * urgency (≥3 episodes/24 hrs.) ± urge urinary incontinence * urinary frequency (≥8 times/24 hrs.) * nocturia (awakening ≥2 times at night)
Exclusion criteria
* hematuria * abdominal pain * fever * cognitive impairment (Mini-Cog \< 3) * positive screen for depression (PHQ2 \> 3) * hearing issues * uncorrected visual difficulties
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overactive bladder- health related quality of life (OAB HRQOL) | Baseline and at one, six, and 12 weeks | The OAB-q is a 33-item measure to assess impact of OAB symptoms on HRQOL. The OAB-q consists of a symptom bother scale and four HRQOL subscales (coping, concern, sleep, and social interaction). All scale scores are transformed to a 0-to-100-point scale, with higher symptom bother scores indicating greater symptom severity, and lower total and subscale scores indicating improvement in HRQOL.27 A 10-point change in these scales indicates a minimal clinically important difference (MCID). The Cronbach alpha coefficient in this study was 0.88. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perception of Bladder Condition (PPBC) | Baseline and at one, six, and 12 weeks | The PPBC is a single-item, six-point rating scale of participants subjective assessment of their bladder symptoms, with the question My bladder causes… me no (1), very minor (2), minor (3), moderate (4), severe (5), or many severe (6) problems. A two-point negative change indicates an MCID.28 |
| Overactive bladder symptoms | 12 weeks duration | Participants completed daily bladder diaries data for 12 weeks with information on date, beverage, quantity and time of fluid intake, voiding frequency, voiding volume quantified, urge-related episodes with or without urinary incontinence, and the circumstances of each episode. At each visit, research associates would review bladder diaries to ensure that entries were clear and interpretable. A research associate, blinded to group assignment, scored bladder diaries and managed the data. |
| Geriatric Self-Efficacy Index for Urinary Incontinence (GSEI) | Baseline and at one, six, and 12 weeks | The GSEI measures older adults' level of confidence in preventing incontinence episodes. Total scores for the GSEI were computed by summing the scores from each of the 16 items (minimum 0, maximum 10 points per item, range 0-160); a minimum 20-point difference suggests an MCID. The Cronbach alpha coefficient in this study was 0.91.29 We also asked participants at baseline and at one, six, and 12 weeks to describe their confidence in doing pelvic floor muscle exercises: How confident are you in doing pelvic floor muscle exercises? and their ability to suppress urge: How confident are you in suppressing the urge? on a 100 mm visual analog scales (VAS). The 100 mm VAS was in the range of 0, not at all confident to 10, extremely confident. |
| Adherence to Pelvic Floor Muscle Exercises (PFMEs) | Baseline and at one, six, and 12 weeks | Participants were asked how often they had performed PFME in the previous week (0=do not perform, 1=once a week, 2=twice a week once a day, 3=twice a week more than once a day, 4=alternate days once a day, 5= alternate day more than once, 6=every day of the week once a day, 7=every day of the week more than once a day). We also asked about the number of repetitions they did during each exercise session (0=1-2 times, 1=2-4 times, 3=4-6 times, 4=6-8 times, 5=8-10 times, 6=more than 10 times). |
| Avatar Recognition | At 12 weeks | The research associate asked participants if they recognized the face of the avatars in the tutorials at 12 weeks with a single question: Who did the avatar look like? |
Countries
United States
Outcome results
None listed