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

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

Study Overview

• Status: Recruiting
• Conditions: Overactive Bladder; Pelvic Floor Disorders; Urge Incontinence

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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Yufan Chen, MD; Phone Number: 510-364-2122; Email: brandon@renalis.health
• Study Contact Backup: Name: Missy Lavender; Email: Missy@renalis.health

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals Cleveland Medical Center
      • Contact: David Sheyn, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Renalis
• Collaborators: University Hospitals Cleveland Medical Center
• Investigators: Principal Investigator: David Sheyn, MD, University Hospitals Cleveland Medical Center

Publications and helpful links

General 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.
• 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.
• Ostaszkiewicz J, Johnston L, Roe B. Timed voiding for the management of urinary incontinence in adults. Cochrane Database Syst Rev. 2004;(1):CD002802. Review.
• Ostaszkiewicz J, Johnston L, Roe B. Habit retraining for the management of urinary incontinence in adults. Cochrane Database Syst Rev. 2004;(2):CD002801. 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.
• 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

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2021
• Primary Completion (Anticipated): April 30, 2022
• Study Completion (Anticipated): April 30, 2024

Study Registration Dates

• First Submitted: March 26, 2021
• First Submitted That Met QC Criteria: April 17, 2021
• First Posted (Actual): April 21, 2021

Study Record Updates

• Last Update Posted (Actual): December 10, 2021
• Last Update Submitted That Met QC Criteria: November 27, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Overactive bladder; Urge incontinence; Digital therapeutic; Pelvic floor disorders
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Pregnancy Complications; Urinary Incontinence; Urinary Bladder, Overactive; Pelvic Floor Disorders; Urinary Incontinence, Urge
• Other Study ID Numbers: CECE2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No