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| Name | Class |
|---|---|
| American Urogynecologic Society | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Interstitial Cystitis Symptom Index | Validated measure of IC/BPS symptom severity. Minimum 0 - Maximum 20; higher score means a worse outcome | Score at baseline and 6 weeks |
| Change in Interstitial Cystitis Problem Index |
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Inclusion criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34599672 | Background | 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. | |
| 9146003 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | ERICA | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ERICA | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Pain Self Efficacy Scale | Validated measure of self-efficacy. Minimum 0 - Maximum 60; higher score means a better outcome | Posted | Median | Inter-Quartile Range | score on a scale | Score at baseline and 6 weeks |
|
6 weeks
This study tested a smartphone-based self-management education platform for patients with IC/BPS. No pharmaceutical, procedural, or surgical interventions were involved. No laboratory or diagnostic testings were involved. Thus, there was neither serious adverse event nor mortality events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ERICA | 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lily Arya, MD | University of Pennsylvania | 267-785-8024 | larya@pennmedicine.upenn.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 2, 2021 | Feb 27, 2024 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 2, 2022 | Aug 6, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D018856 | Cystitis, Interstitial |
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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|
Validated measure of IC/BPS symptoms' impact on quality of life. Minimum 0 - Maximum 16; higher score means a worse outcome
| 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 | 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 | 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 | Score at baseline and 6 weeks |
| 25623737 | 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. |
| 27581769 | 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. |
| 22503015 | 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. |
| 29173267 | 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. |
| 39392616 | Derived | 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. |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| BMI | Body Mass Index | Mean | Inter-Quartile Range | kg/m^2 |
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| Duration of IC/BPS symptoms in years | Duration in years that participant has had Intercystitis/Bladder Pain Syndrome symptoms | Median | Inter-Quartile Range | years |
|
| Duration of IC/BPS diagnosis in years | Time in years that participant has been diagnosed with Intercystitis/Bladder Pain Syndrome | Median | Inter-Quartile Range | years |
|
| Post-menopause | Number of post-menopausal participants | Count of Participants | Participants |
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| Prior treatments: Dietary modification | Number of participants previously treated with dietary modification | Count of Participants | Participants |
|
| Prior treatment: Pelvic floor physical therapy | Number of participants previously treated with pelvic floor physical therapy | Count of Participants | Participants |
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| Prior treatment: Bladder analgesic | Number of participants previously treated with bladder analgesics such as Phenazopyridine. | Count of Participants | Participants |
|
| Prior treatment: Pentosan polysulfate sodium | Number of participants previously treated with penotsan polysulfate sodium | Count of Participants | Participants |
|
| Prior treatment: Tricyclic antidepressant | Number of participants previously treated with tricyclic antidepressant (e.g. amitriptyline) | Count of Participants | Participants |
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| Prior treatment: Antihistamine | Number of participants previously treated with antihistimine, e.g. hydroxyzine | Count of Participants | Participants |
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| Prior treatment: Psychotherapy | Number of participants previously treated with psychotherapy | Count of Participants | Participants |
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| Prior treatment: Mindfulness practice | Number of participants previously treated with mindfulness practice | Count of Participants | Participants |
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| Prior treatment: Yoga | Count of Participants | Participants |
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| Prior treatment: Cannabinoids | Count of Participants | Participants |
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| Prior treatment: Prescription opioids | Number of participants previously treated with prescription opioids | Count of Participants | Participants |
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| Prior treatment: Bladder instillation | Number of participants previously treated with bladder instillation | Count of Participants | Participants |
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| Prior treatment: Hydrodistention | Number of participants previously treated with hydrodistention | Count of Participants | Participants |
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| Prior treatment: Fulguration of Hunner lesions | Number of participants previously treated with fulguration of Hunner lesions. | Count of Participants | Participants |
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| Concomitant conditions: anxiety disorder | Count of Participants | Participants |
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| Concomitant conditions: depressive disorder | Count of Participants | Participants |
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| Concomitant conditions: anorexia | Count of Participants | Participants |
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| Concomitant conditions: endometriosis | Count of Participants | Participants |
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| Concomitant conditions: pelvic inflammatory disease | Count of Participants | Participants |
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| Concomitant conditions: vulvodynia | Count of Participants | Participants |
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| Concomitant conditions: irritable bowel syndrome | Count of Participants | Participants |
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| Concomitant conditions: inflammatory bowel disease | Count of Participants | Participants |
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| Concomitant conditions: migraine | Count of Participants | Participants |
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| Concomitant conditions: fibromyalgia | Count of Participants | Participants |
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| Concomitant conditions: chronic low back pain | Count of Participants | Participants |
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| Tobacco smoking | Count of Participants | Participants |
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| Alcohol Use | Count of Participants | Participants |
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| Provider the IC/BPS diagnosis was made by | Count of Participants | Participants |
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| Secondary | Change in Interstitial Cystitis Symptom Index | Validated measure of IC/BPS symptom severity. Minimum 0 - Maximum 20; higher score means a worse outcome | Posted | Median | Inter-Quartile Range | score on a scale | Score at baseline and 6 weeks |
|
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| Secondary | 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 | Posted | Median | Inter-Quartile Range | score on a scale | Scores at baseline and 6 weeks |
|
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| Secondary | Change in Hospital Anxiety and Depression Scale - Anxiety Subscale | Validated measure of anxiety level. Minimum 0 - Maximum 21; higher score means a worse outcome | Posted | Median | Inter-Quartile Range | score on a scale | Score at baseline and 6 weeks |
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| Secondary | Change in Hospital Anxiety and Depression Scale - Depression Subscale | Validated measure of depression level. Minimum 0 - Maximum 21; higher score means a worse outcome | Posted | Median | Inter-Quartile Range | score on a scale | Score at baseline and 6 weeks. |
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| Secondary | 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 | Posted | Median | Inter-Quartile Range | score on a scale | Score at baseline and 6 weeks |
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| 0 |
| 52 |
| 0 |
| 52 |
| 0 |
| 52 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |