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

  • End date
    Apr 30, 2024
  • participants needed
  • sponsor
Updated on 15 December 2021
botulinum toxin
behavioral therapy
overactive bladder
mixed incontinence


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


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.

Condition Overactive Bladder, Urge Incontinence, Pelvic Floor Disorders
Clinical Study IdentifierNCT04853849
Last Modified on15 December 2021


Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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