NCT04853849|UnknownDMC
Treatment of Overactive Bladder With a Digital Conversational Agent: the MOTIVATION Study
MOTIVATION
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MOTIVATION
Sponsor study identifier
observational
50
1 country
1
Study Start
August 26, 2021
Actual (reported)Primary Completion
April 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This is a proof of concept study for a digital therapeutic designed to provide first-line behavioral modification therapy for overactive bladder.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 26, 2021
Actual (reported)April 21, 2021
Actual (reported)August 26, 2021
Actual (reported)April 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Change in symptoms of Overactive bladder
Baseline, 4 weeks, and 8 weeks
Change in general health state
Baseline, 4 weeks, and 8 weeks
Research will be conducted at all University Hospital sites that have a member of the Female Pelvic Medicine and Reconstructive Surgery division seeing patients. This includes UH Richmond, UH Bedford, St. Johns Westshore Medical Center, Landerbook Medical Center, UH Portage Urology, UH Geauga Urology, UHCMC, and UH Westlake. Women 40 years or older with overactive bladder will be screened for and offered study enrollment by the study investigators at each of the above sites.
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
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.
David Sheyn, MD
University Hospitals Cleveland Medical Center
First Submitted
March 26, 2021
First Posted
April 21, 2021
Study Start
August 26, 2021
Actual (reported)Primary Completion
April 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Efficacy of Animated Videos to Foster Healthy Bladder Behaviors in Community Women
Global impression of improvement
At 4 weeks
Global impression of improvement
At 8 weeks
Change in anxiety
Baseline, 4 weeks, and 8 weeks
Contact the study team to confirm eligibility.
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.
Study Completion
April 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 10, 2021
Record last verified: 2021-11
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Source: ClinicalTrials.gov.
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