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

Cystitis, Interstitial Clinical Trial

— ERICA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05260112
• Other study ID #: 844895
• Status: Completed
• Phase: N/A
• Start date: November 5, 2021
• Est. completion date: March 31, 2023

Study information

• Verified date: April 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystitis
• Cystitis, Interstitial

Intervention

Other:
• ERICA
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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	American Urogynecologic Society

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interstitial Cystitis Problem Index (ICPI)	O'Leary-Sant Interstitial Cystitis Problem Index Validated questionnaire to assess IC symptom bother.	Change from baseline ICPI at the completion of this 6-week program