Cystitis, Interstitial
Conditions
Keywords
Self-management, Technology, Text message, Multimedia, Pelvic floor physical therapy, Mindfulness, Cognitive behavioral therapy
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.
Interventions
OTHERERICA
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.
Sponsors
American Urogynecologic Society
University of Pennsylvania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Self Efficacy Scale | Score at baseline and 6 weeks | Validated measure of self-efficacy. Minimum 0 - Maximum 60; higher score means a better outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Interstitial Cystitis Symptom Index | Score at baseline and 6 weeks | Validated measure of IC/BPS symptom severity. Minimum 0 - Maximum 20; higher score means a worse outcome |
| Change in Interstitial Cystitis Problem Index | Scores at baseline and 6 weeks | Validated measure of IC/BPS symptoms' impact on quality of life. Minimum 0 - Maximum 16; higher score means a worse outcome |
| Change in Hospital Anxiety and Depression Scale - Anxiety Subscale | Score at baseline and 6 weeks | Validated measure of anxiety level. Minimum 0 - Maximum 21; higher score means a worse outcome |
| Change in Hospital Anxiety and Depression Scale - Depression Subscale | Score at baseline and 6 weeks. | Validated measure of depression level. Minimum 0 - Maximum 21; higher score means a worse outcome |
| Change in Brief Health Care Climate Questionnaire | Score at baseline and 6 weeks | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 52 |
| Total | 52 |
Baseline characteristics
| Characteristic | ERICA |
|---|---|
| Age, Continuous | 41 years |
| Alcohol Use | 27 Participants |
| BMI | 23.8 kg/m^2 |
| Concomitant conditions: anorexia | 4 Participants |
| Concomitant conditions: anxiety disorder | 35 Participants |
| Concomitant conditions: chronic low back pain | 12 Participants |
| Concomitant conditions: depressive disorder | 17 Participants |
| Concomitant conditions: endometriosis | 8 Participants |
| Concomitant conditions: fibromyalgia | 8 Participants |
| Concomitant conditions: inflammatory bowel disease | 2 Participants |
| Concomitant conditions: irritable bowel syndrome | 13 Participants |
| Concomitant conditions: migraine | 16 Participants |
| Concomitant conditions: pelvic inflammatory disease | 2 Participants |
| Concomitant conditions: vulvodynia | 8 Participants |
| Duration of IC/BPS diagnosis in years | 2.5 years |
| Duration of IC/BPS symptoms in years | 4 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 47 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Post-menopause | 9 Participants |
| Prior treatment: Antihistamine | 18 Participants |
| Prior treatment: Bladder analgesic | 34 Participants |
| Prior treatment: Bladder instillation | 4 Participants |
| Prior treatment: Cannabinoids | 12 Participants |
| Prior treatment: Fulguration of Hunner lesions | 2 Participants |
| Prior treatment: Hydrodistention | 5 Participants |
| Prior treatment: Mindfulness practice | 16 Participants |
| Prior treatment: Pelvic floor physical therapy | 26 Participants |
| Prior treatment: Pentosan polysulfate sodium | 4 Participants |
| Prior treatment: Prescription opioids | 3 Participants |
| Prior treatment: Psychotherapy | 10 Participants |
| Prior treatments: Dietary modification | 12 Participants |
| Prior treatment: Tricyclic antidepressant | 13 Participants |
| Prior treatment: Yoga | 13 Participants |
| Provider the IC/BPS diagnosis was made by Gynecologist | 2 Participants |
| Provider the IC/BPS diagnosis was made by Primary Care provider | 2 Participants |
| Provider the IC/BPS diagnosis was made by Urogynecologist | 30 Participants |
| Provider the IC/BPS diagnosis was made by Urologist | 18 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 45 Participants |
| Region of Enrollment United States | 52 participants |
| Sex/Gender, Customized Sex/Gender Female | 49 Participants |
| Sex/Gender, Customized Sex/Gender Non-binary | 3 Participants |
| Tobacco smoking | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 52 |
| other Total, other adverse events | 0 / 52 |
| serious Total, serious adverse events | 0 / 52 |
Outcome results
Primary
Change in Pain Self Efficacy Scale
Validated measure of self-efficacy. Minimum 0 - Maximum 60; higher score means a better outcome
Time frame: Score at baseline and 6 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ERICA | Change in Pain Self Efficacy Scale | 10 score on a scale |
p-value: <0.001Wilcoxon (Mann-Whitney)
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
Time frame: Score at baseline and 6 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ERICA | Change in Brief Health Care Climate Questionnaire | 4 score on a scale |
p-value: <0.001Wilcoxon (Mann-Whitney)
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
Time frame: Score at baseline and 6 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ERICA | Change in Hospital Anxiety and Depression Scale - Anxiety Subscale | -2 score on a scale |
p-value: <0.001Wilcoxon (Mann-Whitney)
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
Time frame: Score at baseline and 6 weeks.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ERICA | Change in Hospital Anxiety and Depression Scale - Depression Subscale | 0 score on a scale |
p-value: 0.53Wilcoxon (Mann-Whitney)
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
Time frame: Scores at baseline and 6 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ERICA | Change in Interstitial Cystitis Problem Index | -2 score on a scale |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Change in Interstitial Cystitis Symptom Index
Validated measure of IC/BPS symptom severity. Minimum 0 - Maximum 20; higher score means a worse outcome
Time frame: Score at baseline and 6 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ERICA | Change in Interstitial Cystitis Symptom Index | -3 score on a scale |
p-value: <0.001Wilcoxon (Mann-Whitney)