N/A
Completed N=52
Smartphone-based Self-care Education Program for Women With Interstitial Cystitis: Educational Remote IC Aide
Cystitis, Interstitial
Source: ClinicalTrials.gov NCT05260112 ↗
Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcomePrimary: Change in Pain Self Efficacy Scale — 10 score on a scale — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Self Efficacy Scale |
10 | <0.001 sig |
| SECONDARY Change in Interstitial Cystitis Symptom Index |
-3 | <0.001 sig |
| SECONDARY Change in Interstitial Cystitis Problem Index |
-2 | <0.001 sig |
| SECONDARY Change in Hospital Anxiety and Depression Scale - Anxiety Subscale |
-2 | <0.001 sig |
| SECONDARY Change in Hospital Anxiety and Depression Scale - Depression Subscale |
— | 0.53 |
| SECONDARY Change in Brief Health Care Climate Questionnaire |
4 | <0.001 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05260112). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.