Cystitis, InterstitialERICANCT05260112
Smartphone-based Self-care Education Program for Women With Interstitial Cystitis: Educational Remote IC Aide
A study testing ERICA in people with Cystitis, Interstitial, run by University of Pennsylvania at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cystitis, Interstitial
- What is being tested?
- ERICA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2021to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Implementation of a Text Message and Multimedia-based Program for Women Newly Diagnosed With Interstitial Cystitis/Bladder Pain Syndrome
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
- Being tested
- ERICA
- Keywords
- Self-management, Technology, Text message, Multimedia, Pelvic floor physical therapy, Mindfulness, Cognitive behavioral therapy
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERICAOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: ERICA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Self Efficacy Scale
Validated measure of self-efficacy. Minimum 0 - Maximum 60; higher score means a better outcome
Measured: Score at baseline and 6 weeks
Secondary outcomes (5)
Change in Interstitial Cystitis Symptom Index
Validated measure of IC/BPS symptom severity. Minimum 0 - Maximum 20; higher score means a worse outcome
Measured: Score at baseline and 6 weeks
Change in Interstitial Cystitis Problem Index
Validated measure of IC/BPS symptoms' impact on quality of life. Minimum 0 - Maximum 16; higher score means a worse outcome
Measured: Scores at baseline and 6 weeks
Change in Hospital Anxiety and Depression Scale - Anxiety Subscale
Validated measure of anxiety level. Minimum 0 - Maximum 21; higher score means a worse outcome
Measured: Score at baseline and 6 weeks
Change in Hospital Anxiety and Depression Scale - Depression Subscale
Validated measure of depression level. Minimum 0 - Maximum 21; higher score means a worse outcome
Measured: Score at baseline and 6 weeks.
Change in Brief Health Care Climate Questionnaire
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
Measured: Score at baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start5 Nov 2021
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cystitis, InterstitialStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- American Urogynecologic Society
- Responsible party
- Principal investigator, Lily Arya, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260112
- Sponsor's protocol ID
- 844895
- Acronym
- ERICA
- Status last verified
- Nov 2024
- First submitted
- 9 Feb 2022
- Last updated
- 6 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34599672O'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.
PubMed 9146003Hanno 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.
PubMed 25623737Kanter 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.
PubMed 27581769FitzGerald 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.
PubMed 22503015Lusty 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.
PubMed 29173267Kim 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.
PubMed 39392616
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Text Message and Multimedia-based Program for Women Newly Diagnosed With Interstitial Cystitis/Bladder Pain Syndrome
- ClinicalTrials.gov ID
- NCT05260112
- Acronym / sponsor ID
- ERICA / 844895
- Conditions
- Cystitis, Interstitial
- Keywords
- Self-management, Technology, Text message, Multimedia, Pelvic floor physical therapy, Mindfulness, Cognitive behavioral therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- American Urogynecologic Society
- Study start
- 5 Nov 2021 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 2 Mar 2022 (actual)
- Results
- Posted 6 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ERICA | Experimental | Other: ERICAERICA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERICAOver 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. | Other | ERICA |
Primary outcome
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
5 secondary outcomes
Change in Interstitial Cystitis Symptom Index
Time frame: Score at baseline and 6 weeks
Change in Interstitial Cystitis Problem Index
Time frame: Scores at baseline and 6 weeks
Change in Hospital Anxiety and Depression Scale - Anxiety Subscale
Time frame: Score at baseline and 6 weeks
Change in Hospital Anxiety and Depression Scale - Depression Subscale
Time frame: Score at baseline and 6 weeks.
Change in Brief Health Care Climate Questionnaire
Time frame: Score at baseline and 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 34599672Hassani 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.
- Background: PubMed 9146003O'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.
- Background: PubMed 25623737Hanno 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.
- Background: PubMed 27581769Kanter 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.
- Background: PubMed 22503015FitzGerald 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.
- Background: PubMed 29173267Lusty 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.
- Derived from this study: PubMed 39392616Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERICA in people with Cystitis, Interstitial, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Self Efficacy Scale (time frame: Score at baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05260112, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025; AzTrials last refreshed its copy on 31 Oct 2026.