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Completed

NCT Number: NCT05260112

Smartphone-based Self-care Education Program for Women With Interstitial Cystitis: Educational Remote IC Aide

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.

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Key information

Conditions

Cystitis, Interstitial Cystitis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ERICA

Other

Over 6 weeks, participants receive evidence-based video learning modules twice a week via a secure and HIPAA-compliant text messaging platform. These modules include: patient education on interstitial cystitis, bladder training, trial of an elimination diet, pelvic floor physical therapy including at-home myofascial trigger point release, guided mindfulness practice, and cognitive behavioral therapy for chronic pain.

At the end of each week, participants receive a check-in message. They also have the opportunity to text questions and concerns, which will be answered using an algorithm-based, clinically validated responses.

Primary outcomes

  1. 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

  1. Change in Interstitial Cystitis Symptom Index

    Time frame: Score at baseline and 6 weeks

    Validated measure of IC/BPS symptom severity. Minimum 0 - Maximum 20; higher score means a worse outcome

  2. Change in Interstitial Cystitis Problem Index

    Time frame: Scores at baseline and 6 weeks

    Validated measure of IC/BPS symptoms' impact on quality of life. Minimum 0 - Maximum 16; higher score means a worse outcome

  3. Change in Hospital Anxiety and Depression Scale - Anxiety Subscale

    Time frame: Score at baseline and 6 weeks

    Validated measure of anxiety level. Minimum 0 - Maximum 21; higher score means a worse outcome

  4. Change in Hospital Anxiety and Depression Scale - Depression Subscale

    Time frame: Score at baseline and 6 weeks.

    Validated measure of depression level. Minimum 0 - Maximum 21; higher score means a worse outcome

  5. Change in Brief Health Care Climate Questionnaire

    Time frame: Score at baseline and 6 weeks

    Validated measure patient's perception of quality of and satisfaction with communication and encounter with the health care system. Minimum 6 - Maximum 30; higher score means a better outcome

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • American Urogynecologic Society

Registry information

Official study title

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

Acronym: ERICA

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 2, 2022
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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