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Overactive BladderMOTIVATIONNCT04853849

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

An observational study of Overactive Bladder and Urge Incontinence, run by Renalis at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 40 years and older, women only
How many people
50 participants
Where
1 siteUnited States
Study dates
26 Aug 2021to 30 Apr 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • Women only
  • Adult, Older adult

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.

Who may be able to join

  • 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
Show all 9Show fewer
  • Greater than 6 months since receiving intradetrusor injection of botulinum toxin
  • Not currently undergoing sacral neuromodulation therapy
  • Not currently receiving pharmacotherapy for overactive bladder

Who cannot join

  • 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
Show all 19Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Yufan Chen, MD contact

510-364-2122

brandon@renalis.health

Missy Lavender contact

Missy@renalis.health

United States1 site, 1 recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

    David Sheyn, MD

    Recruiting

Other trials in United States

About this study

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

Read the 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.

Keywords
Digital therapeutic, Overactive bladder, Urge incontinence, Pelvic floor disorders
Medical subject headings
Urinary Bladder, Overactive, Urinary Incontinence, Urge, Pelvic Floor Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of overactive bladder quality of life measure

    International Consultation on Incontinence Questionnaire Overactive Bladder Quality of Life questionnaire (ICIQ-OAB-QoL) is a 26 item questionnaire evaluating quality of life (QoL) in patients with overactive bladder. Scores range from 25-160, with greater values indicating increased impact on quality of life.

    Measured: Baseline, 4 weeks, and 8 weeks

Secondary outcomes (9)

  1. Change in symptoms of Overactive bladder

    OAB-SS is a symptom assessment questionnaire designed to quantify OAB symptoms. The questionnaire consists of 4 questions. The score ranges from 0-15 with higher score indicating more severe OAB symptoms

    Measured: Baseline, 4 weeks, and 8 weeks

  2. Change in general health state

    SF-36 is a 36 item questionnaire measuring general health. Scores range from 0-100 with higher scores indicating more favorable health state.

    Measured: Baseline, 4 weeks, and 8 weeks

  3. Global impression of improvement

    The Patient Global Impression of Improvement (PGI-I) is a global index used to rate the response of a condition to a therapy. Scores range from 1-7, with higher values (5-7) indicating higher degree is improvement and lower values (1-3) indicating worse outcomes.

    Measured: At 4 weeks

  4. Global impression of improvement

    The Patient Global Impression of Improvement (PGI-I) is a global index used to rate the response of a condition to a therapy. Scores range from 1-7, with higher values (5-7) indicating higher degree is improvement and lower values (1-3) indicating worse outcomes.

    Measured: At 8 weeks

  5. Change in anxiety

    General Anxiety Disorder 7 item (GAD-7) questionnaire is a measure for assessing generalized anxiety disorder. Score ranges from 0-21 with high scores representing more severe depression.

    Measured: Baseline, 4 weeks, and 8 weeks

  6. Usability

    System Usability Scale (SUS) is a 10 item questionnaire for measuring the usability. Scores range from 0-100, with higher scores indicating better usability.

    Measured: 8 weeks

  7. Usability

    Nelson's Attributes of Usability (NAU) is a 19 item questionnaire measuring usability. Scores range from 0-50, with higher scores indicating better usability

    Measured: 8 weeks

  8. Usability

    The Chatbot Usability Questionnaire (CUQ) is a 16 item questionnaire measuring usability of a chatbot. Scores range from 0-100, with higher scores indicating better usability

    Measured: 8 weeks

  9. Mobile device proficiency

    The Mobile Device Proficiency Questionnaire (MDPQ-16) is a 16 item survey. Scores range from 8.5 - 40, with higher values indicating greater proficiency with mobile devices.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2021
  2. Study start26 Aug 2021
  3. Primary completion30 Apr 2022 (estimated)
  4. Study completion30 Apr 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04853849
Sponsor's protocol ID
CECE2021
Acronym
MOTIVATION
Status last verified
Nov 2021
First submitted
26 Mar 2021
Last updated
10 Dec 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 10571620

  • 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.

    PubMed 26000514

  • 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.

    PubMed 14973993

  • 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.

    PubMed 15106179

  • 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.

    PubMed 17184371

  • 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.

    PubMed 25349943

  • 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.

    PubMed 30527941

  • 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

  • Sheyn D, Chakraborty N, Chen YB, Mahajan ST, Hijaz A. Use of a Digital Conversational Agent for the Management of Overactive Bladder. Urogynecology (Phila). 2024 Jun 1;30(6):536-544. doi: 10.1097/SPV.0000000000001428. Epub 2023 Nov 6.

    PubMed 37930265

Questions about this trial

What is this clinical trial studying?

An observational study of Overactive Bladder and Urge Incontinence, run by Renalis at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yufan Chen, MD (510-364-2122, brandon@renalis.health), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of overactive bladder quality of life measure (time frame: Baseline, 4 weeks, and 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04853849, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2021.

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