Clinical trial NCT05260112: Smartphone-based Self-care Education Program for Women With Interstitial Cystitis: Educational Remote IC Aide
Official title: Implementation of a Text Message and Multimedia-based Program for Women Newly Diagnosed With Interstitial Cystitis/Bladder Pain Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystitis, Interstitial
Keywords: Self-management
Technology
Text message
Multimedia
Pelvic floor physical therapy
Mindfulness
Cognitive behavioral therapy
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: American Urogynecologic Society
First posted: 2022-03-02
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Pain Self Efficacy Scale
timeFrame: Score at baseline and 6 weeks
Secondary outcomes:
measure: Change in Interstitial Cystitis Symptom Index
timeFrame: Score at baseline and 6 weeks
measure: Change in Interstitial Cystitis Problem Index
timeFrame: Scores at baseline and 6 weeks
measure: Change in Hospital Anxiety and Depression Scale - Anxiety Subscale
timeFrame: Score at baseline and 6 weeks
measure: Change in Hospital Anxiety and Depression Scale - Depression Subscale
timeFrame: Score at baseline and 6 weeks.
measure: Change in Brief Health Care Climate Questionnaire
timeFrame: Score at baseline and 6 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
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.
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.
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.
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.
citation: 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.
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.