Treatment of Overactive Bladder With a Digital Conversational Agent: the MOTIVATION Study
NCT ID: NCT04853849
Last Updated: 2021-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
50 participants
OBSERVATIONAL
2021-08-26
2024-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
FEMALE
No
Sponsors
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University Hospitals Cleveland Medical Center
OTHER
Renalis
INDUSTRY
Responsible Party
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Principal Investigators
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David Sheyn, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center
Locations
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University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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David Sheyn, MD
Role: primary
References
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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. doi: 10.1046/j.1464-410x.1999.00390.x.
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.
Ostaszkiewicz J, Johnston L, Roe B. Timed voiding for the management of urinary incontinence in adults. Cochrane Database Syst Rev. 2004;2004(1):CD002802. doi: 10.1002/14651858.CD002802.pub2.
Ostaszkiewicz J, Johnston L, Roe B. Habit retraining for the management of urinary incontinence in adults. Cochrane Database Syst Rev. 2004;2004(2):CD002801. doi: 10.1002/14651858.CD002801.pub2.
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. doi: 10.1111/j.1365-2648.2006.04097.x.
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.
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
Sheyn D, Chakraborty N, Chen YB, Mahajan ST, Hijaz A. Use of a Digital Conversational Agent for the Management of Overactive Bladder. Urogynecology (Phila). 2024 Jun 1;30(6):536-544. doi: 10.1097/SPV.0000000000001428. Epub 2023 Nov 6.
Other Identifiers
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CECE2021
Identifier Type: -
Identifier Source: org_study_id