Overactive Bladder, Pelvic Floor Disorders, Urge Incontinence
Conditions
Keywords
Digital therapeutic, Overactive bladder, Urge incontinence, Pelvic floor disorders
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.
Interventions
None listed
Sponsors
University Hospitals Cleveland Medical Center
Renalis
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of overactive bladder quality of life measure | Baseline, 4 weeks, and 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in general health state | Baseline, 4 weeks, and 8 weeks | SF-36 is a 36 item questionnaire measuring general health. Scores range from 0-100 with higher scores indicating more favorable health state. |
| Global impression of improvement | At 4 weeks | 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. |
| Change in symptoms of Overactive bladder | Baseline, 4 weeks, and 8 weeks | 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 |
| Usability | 8 weeks | System Usability Scale (SUS) is a 10 item questionnaire for measuring the usability. Scores range from 0-100, with higher scores indicating better usability. |
| Mobile device proficiency | Baseline | 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. |
| Change in anxiety | Baseline, 4 weeks, and 8 weeks | 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. |
Countries
United States
Contacts
Primary ContactYufan Chen, MD
Backup ContactMissy Lavender
Outcome results
None listed