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

Primary Purpose

Cystitis, Interstitial

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ERICA
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystitis, Interstitial focused on measuring Self-management, Technology, Text message, Multimedia, Pelvic floor physical therapy, Mindfulness, Cognitive behavioral therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ERICA

Arm Description

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.

Outcomes

Primary Outcome Measures

Interstitial Cystitis Problem Index (ICPI)
O'Leary-Sant Interstitial Cystitis Problem Index Validated questionnaire to assess IC symptom bother.

Secondary Outcome Measures

Full Information

First Posted
February 9, 2022
Last Updated
April 19, 2023
Sponsor
University of Pennsylvania
Collaborators
American Urogynecologic Society
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1. Study Identification

Unique Protocol Identification Number
NCT05260112
Brief Title
Smartphone-based Self-care Education Program for Women With Interstitial Cystitis: Educational Remote IC Aide
Acronym
ERICA
Official Title
Implementation of a Text Message and Multimedia-based Program for Women Newly Diagnosed With Interstitial Cystitis/Bladder Pain Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 5, 2021 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
March 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
Collaborators
American Urogynecologic Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystitis, Interstitial
Keywords
Self-management, Technology, Text message, Multimedia, Pelvic floor physical therapy, Mindfulness, Cognitive behavioral therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ERICA
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
ERICA
Intervention Description
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 Outcome Measure Information:
Title
Interstitial Cystitis Problem Index (ICPI)
Description
O'Leary-Sant Interstitial Cystitis Problem Index Validated questionnaire to assess IC symptom bother.
Time Frame
Change from baseline ICPI at the completion of this 6-week program

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34599672
Citation
Hassani D, Flick L, Sangha H, Brown LA, Andy U, Arya L. How do women with interstitial cystitis/bladder pain syndrome make treatment choices? Int Urogynecol J. 2022 Mar;33(3):583-593. doi: 10.1007/s00192-021-04994-6. Epub 2021 Oct 2.
Results Reference
background
PubMed Identifier
9146003
Citation
O'Leary MP, Sant GR, Fowler FJ Jr, Whitmore KE, Spolarich-Kroll J. The interstitial cystitis symptom index and problem index. Urology. 1997 May;49(5A Suppl):58-63. doi: 10.1016/s0090-4295(99)80333-1.
Results Reference
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PubMed Identifier
25623737
Citation
Hanno PM, Erickson D, Moldwin R, Faraday MM; American Urological Association. Diagnosis and treatment of interstitial cystitis/bladder pain syndrome: AUA guideline amendment. J Urol. 2015 May;193(5):1545-53. doi: 10.1016/j.juro.2015.01.086. Epub 2015 Jan 23.
Results Reference
background
PubMed Identifier
27581769
Citation
Kanter G, Volpe KA, Dunivan GC, Cichowski SB, Jeppson PC, Rogers RG, Komesu YM. Important role of physicians in addressing psychological aspects of interstitial cystitis/bladder pain syndrome (IC/BPS): a qualitative analysis. Int Urogynecol J. 2017 Feb;28(2):249-256. doi: 10.1007/s00192-016-3109-2. Epub 2016 Aug 31.
Results Reference
background
PubMed Identifier
22503015
Citation
FitzGerald MP, Payne CK, Lukacz ES, Yang CC, Peters KM, Chai TC, Nickel JC, Hanno PM, Kreder KJ, Burks DA, Mayer R, Kotarinos R, Fortman C, Allen TM, Fraser L, Mason-Cover M, Furey C, Odabachian L, Sanfield A, Chu J, Huestis K, Tata GE, Dugan N, Sheth H, Bewyer K, Anaeme A, Newton K, Featherstone W, Halle-Podell R, Cen L, Landis JR, Propert KJ, Foster HE Jr, Kusek JW, Nyberg LM; Interstitial Cystitis Collaborative Research Network. Randomized multicenter clinical trial of myofascial physical therapy in women with interstitial cystitis/painful bladder syndrome and pelvic floor tenderness. J Urol. 2012 Jun;187(6):2113-8. doi: 10.1016/j.juro.2012.01.123. Epub 2012 Apr 12.
Results Reference
background
PubMed Identifier
29173267
Citation
Lusty A, Kavaler E, Zakariasen K, Tolls V, Nickel JC. Treatment effectiveness in interstitial cystitis/bladder pain syndrome: Do patient perceptions align with efficacy-based guidelines? Can Urol Assoc J. 2018 Jan;12(1):E1-E5. doi: 10.5489/cuaj.4505. Epub 2017 Dec 1.
Results Reference
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Smartphone-based Self-care Education Program for Women With Interstitial Cystitis: Educational Remote IC Aide

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