NCT04853849

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Renalis · Industry
• Sex: Female
• Age: 40 Years
• Healthy volunteers: —

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.

Conditions

• Overactive Bladder
• Urge Incontinence
• Pelvic Floor Disorders

Timeline

• Start date: 2021-08-26
• Primary completion: 2022-04-30
• Completion: 2024-04-30
• First posted: 2021-04-21
• Last updated: 2021-12-10

Locations

1 site across 1 country: United States