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

Overactive Bladder Clinical Trial

— MOTIVATION  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04853849
• Other study ID #: CECE2021
• Status: Recruiting
• Start date: August 26, 2021
• Est. completion date: April 30, 2024

Study information

• Verified date: November 2021
• Source: Renalis
• Contact: Yufan Chen, MD
• Phone: 510-364-2122
• Email: brandon[@]renalis.health
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2022
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Renalis	University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

Ostaszkiewicz J, Johnston L, Roe B. Habit retraining for the management of urinary incontinence in adults. Cochrane Database Syst Rev. 2004;(2):CD002801. Review. — View Citation

Ostaszkiewicz J, Johnston L, Roe B. Timed voiding for the management of urinary incontinence in adults. Cochrane Database Syst Rev. 2004;(1):CD002802. Review. — View Citation

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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