Clinical trial NCT04853849: Treatment of Overactive Bladder With a Digital Conversational Agent: the MOTIVATION Study
Official title: Treatment of Overactive Bladder With a Digital Conversational Agent: the MOTIVATION Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Overactive Bladder
Urge Incontinence
Pelvic Floor Disorders
Keywords: Digital therapeutic
Overactive bladder
Urge incontinence
Pelvic floor disorders
Lead sponsor: Renalis
Sponsor class: INDUSTRY
Collaborators: name: University Hospitals Cleveland Medical Center
First posted: 2021-04-21
Enrollment: 50
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Research will be conducted at all University Hospital sites that have a member of the Female Pelvic Medicine and Reconstructive Surgery division seeing patients. This includes UH Richmond, UH Bedford, St. Johns Westshore Medical Center, Landerbook Medical Center, UH Portage Urology, UH Geauga Urology, UHCMC, and UH Westlake. Women 40 years or older with overactive bladder will be screened for and offered study enrollment by the study investigators at each of the above sites.

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.

Eligibility 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

Primary outcomes:
measure: Change of overactive bladder quality of life measure
timeFrame: Baseline, 4 weeks, and 8 weeks
Secondary outcomes:
measure: Change in symptoms of Overactive bladder
timeFrame: Baseline, 4 weeks, and 8 weeks
measure: Change in general health state
timeFrame: Baseline, 4 weeks, and 8 weeks
measure: Global impression of improvement
timeFrame: At 4 weeks
measure: Global impression of improvement
timeFrame: At 8 weeks
measure: Change in anxiety
timeFrame: Baseline, 4 weeks, and 8 weeks
measure: Usability
timeFrame: 8 weeks
measure: Usability
timeFrame: 8 weeks
measure: Usability
timeFrame: 8 weeks
measure: Mobile device proficiency
timeFrame: Baseline
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: David Sheyn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1046/j.1464-410x.1999.00390.x.
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.
citation: Ostaszkiewicz J, Johnston L, Roe B. Timed voiding for the management of urinary incontinence in adults. Cochrane Database Syst Rev. 2004;2004(1):CD002802. doi: 10.1002/14651858.CD002802.pub2.
citation: Ostaszkiewicz J, Johnston L, Roe B. Habit retraining for the management of urinary incontinence in adults. Cochrane Database Syst Rev. 2004;2004(2):CD002801. doi: 10.1002/14651858.CD002801.pub2.
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. doi: 10.1111/j.1365-2648.2006.04097.x.
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.
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.
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