Treatment of Overactive Bladder With a Digital Conversational Agent: the MOTIVATION Study

Study Overview
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Brief Summary
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This is a proof of concept study for a digital therapeutic designed to provide first-line behavioral modification therapy for overactive bladder.

Detailed Description
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The investigators seek to evaluate a commercial digital therapeutic, called CeCe, designed to provide first-line behavioral modification therapy for overactive bladder (OAB). This digital platform provides daily contact with the user to maximize compliance. It allows a provider to administer behavioral modification treatment while minimizing in-office visits. The investigators expect that a proportion of participants using Cece will experience significant and satisfactory improvement in their voiding symptoms, to the point where no further treatment is necessary. Others will require additional treatment with the usual therapies such physical therapy and medications, per clinical standards. Participants will download CeCe to their smart phones and interact with the program for 8 weeks. Participant consent and specific instructions will be provided during study enrollment and through the app. Study outcomes are collected through the program via in-app questionnaires and voiding diaries. A total of 50 participants will be recruited. They will be compensated a total sum of $175; $50 at completion of an initial set of questionnaires, $50 at completion of 4 week follow-up questionnaires, and $75 at completion of 8 week follow-up.

Official Title
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Treatment of Overactive Bladder With a Digital Conversational Agent: the MOTIVATION Study

Conditions
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Overactive Bladder, Urge Incontinence, Pelvic Floor Disorders

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptoms of overactive bladder with urgency urinary incontinence, with or without nocturia/nocturnal enuresis Symptoms of mixed urinary incontinence if urgency incontinence is the predominant complaint Post-void residual <100ml English speaking Access to a smartphone Normal urinalysis without evidence of UTI, gross or microscopic hematuria Greater than 6 months since receiving intradetrusor injection of botulinum toxin Not currently undergoing sacral neuromodulation therapy Not currently receiving pharmacotherapy for overactive bladder Exclusion Criteria: Less than 40 years of age Mixed incontinence with predominant stress urinary incontinence symptoms Diagnosis of chronic pelvic pain symptomatic pelvic organ prolapse symptoms of dysuria Diagnosis of interstitial cystitis/painful bladder syndrome Reported >2 UTI in 6 months or >3 in 12 months Do not have access to a smartphone Non-English speaking Diagnosis of neurogenic bladder Gross or microscopic hematuria Has diagnosis of dementia, cognitive impairment or other neurologic condition which impairs decision making Current Pharmacotherapy or neuromodulation therapy Less than 6 months since intradetrusor botulinum toxin injection Has decreased mobility or ambulation Has post-void residual >100 mL Has BMI > 40 kg/m^2 Inability to voluntarily contract the pelvic floor muscles (a 0/5 in strength). Has >4/10 pain with palpation of levator ani, coccygeus, pyriformis, obturator internus or perineal body

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of overactive bladder quality of life measure | International Consultation on Incontinence Questionnaire Overactive Bladder Quality of Life questionnaire (ICIQ-OAB-QoL) is a 26 item questionnaire evaluating quality of life (QoL) in patients with overactive bladder. Scores range from 25-160, with greater values indicating increased impact on quality of life. | Baseline, 4 weeks, and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in symptoms of Overactive bladder | OAB-SS is a symptom assessment questionnaire designed to quantify OAB symptoms. The questionnaire consists of 4 questions. The score ranges from 0-15 with higher score indicating more severe OAB symptoms | Baseline, 4 weeks, and 8 weeks | 
| Change in general health state | SF-36 is a 36 item questionnaire measuring general health. Scores range from 0-100 with higher scores indicating more favorable health state. | Baseline, 4 weeks, and 8 weeks | 
| Global impression of improvement | The Patient Global Impression of Improvement (PGI-I) is a global index used to rate the response of a condition to a therapy. Scores range from 1-7, with higher values (5-7) indicating higher degree is improvement and lower values (1-3) indicating worse outcomes. | At 4 weeks | 
| Global impression of improvement | The Patient Global Impression of Improvement (PGI-I) is a global index used to rate the response of a condition to a therapy. Scores range from 1-7, with higher values (5-7) indicating higher degree is improvement and lower values (1-3) indicating worse outcomes. | At 8 weeks | 
| Change in anxiety | General Anxiety Disorder 7 item (GAD-7) questionnaire is a measure for assessing generalized anxiety disorder. Score ranges from 0-21 with high scores representing more severe depression. | Baseline, 4 weeks, and 8 weeks | 
| Usability | System Usability Scale (SUS) is a 10 item questionnaire for measuring the usability. Scores range from 0-100, with higher scores indicating better usability. | 8 weeks | 
| Usability | Nelson's Attributes of Usability (NAU) is a 19 item questionnaire measuring usability. Scores range from 0-50, with higher scores indicating better usability | 8 weeks | 
| Usability | The Chatbot Usability Questionnaire (CUQ) is a 16 item questionnaire measuring usability of a chatbot. Scores range from 0-100, with higher scores indicating better usability | 8 weeks | 
| Mobile device proficiency | The Mobile Device Proficiency Questionnaire (MDPQ-16) is a 16 item survey. Scores range from 8.5 - 40, with higher values indicating greater proficiency with mobile devices. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Digital therapeutic, Overactive bladder, Urge incontinence, Pelvic floor disorders