Status:
UNKNOWN
Treatment of Overactive Bladder With a Digital Conversational Agent: the MOTIVATION Study
Lead Sponsor:
Renalis
Collaborating Sponsors:
University Hospitals Cleveland Medical Center
Conditions:
Overactive Bladder
Urge Incontinence
Eligibility:
FEMALE
40+ years
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 pro...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 26 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 30 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04853849
Start Date
August 26 2021
End Date
April 30 2024
Last Update
December 10 2021
Active Locations (1)
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1
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106