Skip to main content
Clinical Trials/NCT05260112
NCT05260112
Completed
N/A

Implementation of a Text Message and Multimedia-based Program for Women Newly Diagnosed With Interstitial Cystitis/Bladder Pain Syndrome

University of Pennsylvania1 site in 1 country52 target enrollmentNovember 5, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cystitis, Interstitial
Sponsor
University of Pennsylvania
Enrollment
52
Locations
1
Primary Endpoint
Change in Pain Self Efficacy Scale
Status
Completed
Last Updated
last year

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.

Registry
clinicaltrials.gov
Start Date
November 5, 2021
End Date
March 31, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lily Arya

Chief, Urogynecology and Reconstructive Surgery

University of Pennsylvania

Eligibility Criteria

Inclusion Criteria

  • Not provided

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

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 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)
  • 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)

Study Sites (1)

Loading locations...

Similar Trials