Treatment of Overactive Bladder With a Digital Conversational Agent: the MOTIVATION Study
Study Details
Study Description
Brief Summary
This is a proof of concept study for a digital therapeutic designed to provide first-line behavioral modification therapy for overactive bladder.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Outcome Measures
Primary Outcome Measures
- Change of overactive bladder quality of life measure [Baseline, 4 weeks, and 8 weeks]
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.
Secondary Outcome Measures
- Change in symptoms of Overactive bladder [Baseline, 4 weeks, and 8 weeks]
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
- Change in general health state [Baseline, 4 weeks, and 8 weeks]
SF-36 is a 36 item questionnaire measuring general health. Scores range from 0-100 with higher scores indicating more favorable health state.
- Global impression of improvement [At 4 weeks]
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.
- Global impression of improvement [At 8 weeks]
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.
- Change in anxiety [Baseline, 4 weeks, and 8 weeks]
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.
- Usability [8 weeks]
System Usability Scale (SUS) is a 10 item questionnaire for measuring the usability. Scores range from 0-100, with higher scores indicating better usability.
- Usability [8 weeks]
Nelson's Attributes of Usability (NAU) is a 19 item questionnaire measuring usability. Scores range from 0-50, with higher scores indicating better usability
- Usability [8 weeks]
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
- Mobile device proficiency [Baseline]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Symptoms of overactive bladder with urgency urinary incontinence, with or without nocturia/nocturnal enuresis
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Symptoms of mixed urinary incontinence if urgency incontinence is the predominant complaint
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Post-void residual <100ml
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English speaking
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Access to a smartphone
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Normal urinalysis without evidence of UTI, gross or microscopic hematuria
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Greater than 6 months since receiving intradetrusor injection of botulinum toxin
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Not currently undergoing sacral neuromodulation therapy
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Not currently receiving pharmacotherapy for overactive bladder
Exclusion Criteria:
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Less than 40 years of age
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Mixed incontinence with predominant stress urinary incontinence symptoms
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Diagnosis of chronic pelvic pain
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symptomatic pelvic organ prolapse
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symptoms of dysuria
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Diagnosis of interstitial cystitis/painful bladder syndrome
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Reported >2 UTI in 6 months or >3 in 12 months
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Do not have access to a smartphone
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Non-English speaking
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Diagnosis of neurogenic bladder
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Gross or microscopic hematuria
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Has diagnosis of dementia, cognitive impairment or other neurologic condition which impairs decision making
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Current Pharmacotherapy or neuromodulation therapy
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Less than 6 months since intradetrusor botulinum toxin injection
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Has decreased mobility or ambulation
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Has post-void residual >100 mL
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Has BMI > 40 kg/m^2
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Inability to voluntarily contract the pelvic floor muscles (a 0/5 in strength).
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Has >4/10 pain with palpation of levator ani, coccygeus, pyriformis, obturator internus or perineal body
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospitals Cleveland Medical Center | Cleveland | Ohio | United States | 44106 |
Sponsors and Collaborators
- Renalis
- University Hospitals Cleveland Medical Center
Investigators
- Principal Investigator: David Sheyn, MD, University Hospitals Cleveland Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
- Brown K, Hilton P. The incidence of detrusor instability before and after colposuspension: a study using conventional and ambulatory urodynamic monitoring. BJU Int. 1999 Dec;84(9):961-5.
- Kandadai P, O'Dell K, Saini J. Correct performance of pelvic muscle exercises in women reporting prior knowledge. Female Pelvic Med Reconstr Surg. 2015 May-Jun;21(3):135-40. doi: 10.1097/SPV.0000000000000145.
- Meister MR, Sutcliffe S, Ghetti C, Chu CM, Spitznagle T, Warren DK, Lowder JL. Development of a standardized, reproducible screening examination for assessment of pelvic floor myofascial pain. Am J Obstet Gynecol. 2019 Mar;220(3):255.e1-255.e9. doi: 10.1016/j.ajog.2018.11.1106. Epub 2018 Dec 7.
- Ostaszkiewicz J, Johnston L, Roe B. Habit retraining for the management of urinary incontinence in adults. Cochrane Database Syst Rev. 2004;(2):CD002801. Review.
- Ostaszkiewicz J, Johnston L, Roe B. Timed voiding for the management of urinary incontinence in adults. Cochrane Database Syst Rev. 2004;(1):CD002802. Review.
- Reynolds WS, McPheeters M, Blume J, Surawicz T, Worley K, Wang L, Hartmann K. Comparative Effectiveness of Anticholinergic Therapy for Overactive Bladder in Women: A Systematic Review and Meta-analysis. Obstet Gynecol. 2015 Jun;125(6):1423-1432. doi: 10.1097/AOG.0000000000000851. Review.
- Roe B, Ostaszkiewicz J, Milne J, Wallace S. Systematic reviews of bladder training and voiding programmes in adults: a synopsis of findings from data analysis and outcomes using metastudy techniques. J Adv Nurs. 2007 Jan;57(1):15-31. Review.
- Stewart WF, Corey R, Herzog AR, et al. Prevalence of overactive bladder in women: results from the NOBLE program. International Urogynecology Journal 2001; 12: pp. S66
- CECE2021