Implementation of a Text Message and Multimedia-based Program for Women Newly Diagnosed With Interstitial Cystitis/Bladder Pain Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pennsylvania
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Change in Pain Self Efficacy Scale
Study Overview
Brief Summary
To implement and assess clinical efficacy of a text message and multimedia-based program that (i) remotely delivers first- and second-line American Urological Association (AUA) treatments of IC/BPS; (ii) integrates treatment of biological (neuropathic pain, pelvic floor dysfunction), psychological (symptom-related fear and anxiety) and social (barriers in access to care, limited patient-provider communication) domains of IC/BPS; (iii) uses clinically validated messages to provide guidance and support.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women over 18
- •AUA (American Urological Association) criteria for IC/BPS of "an unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms of more than six weeks duration, in the absence of infection or other identifiable causes"
- •Interested in first- or second-line AUA treatment
- •Negative urinalysis and culture within two months of enrollment
- •English-speaking
- •Own a smartphone with text message and video viewing capability
Exclusion Criteria
- •Women currently on third line or higher treatments
- •Currently being treated for UTI
- •History of voiding dysfunction such as urinary retention or neurogenic bladder
- •Recent (<6 months) pelvic surgery/pregnancy
- •Prior pelvic malignancy or radiation
Arms & Interventions
ERICA
ERICA is a smartphone-based educational program that teaches women newly diagnosed with interstitial cystitis evidence-based strategies to self-manage their symptoms at home. The program is designed to bridge the interval/gap between initial visit where they are diagnosed with interstitial cystitis and follow up visit. Participants received video learning modules via a secure and HIPAA-compliant text messaging system.
Intervention: ERICA (Other)
Outcomes
Primary Outcomes
Change in Pain Self Efficacy Scale
Time Frame: Score at baseline and 6 weeks
Validated measure of self-efficacy. Minimum 0 - Maximum 60; higher score means a better outcome
Secondary Outcomes
- Change in Interstitial Cystitis Problem Index(Scores at baseline and 6 weeks)
- Change in Hospital Anxiety and Depression Scale - Anxiety Subscale(Score at baseline and 6 weeks)
- Change in Interstitial Cystitis Symptom Index(Score at baseline and 6 weeks)
- Change in Hospital Anxiety and Depression Scale - Depression Subscale(Score at baseline and 6 weeks.)
- Change in Brief Health Care Climate Questionnaire(Score at baseline and 6 weeks)
Investigators
Lily Arya
Chief, Urogynecology and Reconstructive Surgery
University of Pennsylvania