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

NCT05260112 | Completed Results

• 1 other identifier: 844895
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystitis, Interstitial

Keywords

Self-management; Technology; Text message; Multimedia; Pelvic floor physical therapy; Mindfulness; Cognitive behavioral therapy

Outcome Measures

Primary Outcomes (1)

• Change in Pain Self Efficacy Scale

  Validated measure of self-efficacy. Minimum 0 - Maximum 60; higher score means a better outcome

  Score at baseline and 6 weeks

Secondary Outcomes (5)

• Change in Interstitial Cystitis Symptom Index

  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

• 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

Study Arms (1)

ERICA

EXPERIMENTAL

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.

Other: ERICA

Interventions

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.

ERICA

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• American Urogynecologic Society: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (7)

• 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.

  PMID: 34599672 BACKGROUND

• 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.

  PMID: 9146003 BACKGROUND

• 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.

  PMID: 25623737 BACKGROUND

• 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.

  PMID: 27581769 BACKGROUND

• 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.

  PMID: 22503015 BACKGROUND

• 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.

  PMID: 29173267 BACKGROUND

• Kim EK, Brown LA, Hartzell-Leggin D, Andy UU, Harvie CE, Whitmore KE, Newman DK, Hamm RF, Arya LA. Algorithm-Based Mobile Texting Platform for the Self-Management of Interstitial Cystitis/Bladder Pain Syndrome: Pilot Study Evaluating Feasibility, Usability, and Potential Utility. Urol Pract. 2025 Mar;12(2):203-213. doi: 10.1097/UPJ.0000000000000737. Epub 2024 Oct 11.

  PMID: 39392616 DERIVED

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Lily Arya, MD
• Organization: University of Pennsylvania

larya@pennmedicine.upenn.edu

267-785-8024

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Urogynecology and Reconstructive Surgery

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: March 2, 2022
• Study Start: November 5, 2021
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: January 6, 2025
• Results First Posted: January 6, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)