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

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

Sponsors

Lead Sponsor: Renalis

Collaborator: University Hospitals Cleveland Medical Center

Source Renalis
Brief Summary

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

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.

Overall Status Not yet recruiting
Start Date 2021-05-01
Completion Date 2024-04-30
Primary Completion Date 2022-04-30
Study Type Observational
Primary Outcome
Measure Time Frame
Change of overactive bladder quality of life measure Baseline, 4 weeks, and 8 weeks
Secondary Outcome
Measure Time Frame
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
Usability 8 weeks
Usability 8 weeks
Usability 8 weeks
Mobile device proficiency Baseline
Enrollment 50
Condition
Eligibility

Sampling Method:

Non-Probability Sample

Criteria:

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

Gender:

Female

Minimum Age:

40 Years

Maximum Age:

N/A

Overall Official
Last Name Role Affiliation
David Sheyn, MD Principal Investigator University Hospitals Cleveland Medical Center
Overall Contact

Last Name: Yufan Chen, MD

Phone: 510-364-2122

Email: [email protected]

Verification Date

2021-04-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Acronym MOTIVATION
Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

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