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

NCT04853849 | Unknown DMC

• 1 other identifier: CECE2021
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Overactive Bladder; Urge Incontinence; Pelvic Floor Disorders

Keywords

Digital therapeutic; Overactive bladder; Urge incontinence; Pelvic floor disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change in symptoms of Overactive bladder

  Baseline, 4 weeks, and 8 weeks

• Change in general health state

  Baseline, 4 weeks, and 8 weeks

• Global impression of improvement

  At 4 weeks

• Global impression of improvement

  At 8 weeks

• Change in anxiety

  Baseline, 4 weeks, and 8 weeks

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Renalis: lead
• University Hospitals Cleveland Medical Center: collaborator

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

Related Publications (9)

• 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.

  PMID: 10571620 BACKGROUND

• 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.

  PMID: 26000514 BACKGROUND

• 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.

  PMID: 14973993 BACKGROUND

• 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.

  PMID: 15106179 BACKGROUND

• 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.

  PMID: 17184371 BACKGROUND

• 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.

  PMID: 25349943 BACKGROUND

• 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.

  PMID: 30527941 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 37930265 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge; Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders; Pregnancy Complications

Study Officials

• David Sheyn, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yufan Chen, MD

CONTACT

510-364-2122; brandon@renalis.health

Missy Lavender

CONTACT

Missy@renalis.health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 21, 2021
• Study Start: August 26, 2021
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2024
• Last Updated: December 10, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)