Interstitial Cystitis – Elucidation of Psychophysiologic and Autonomic Characteristics (the ICEPAC Study): design and methods

Abstract

Thomas Chelimsky,1 Gisela Chelimsky,1 N Patrick McCabe,2 Megan Louttit,3 Adonis Hijaz,3 Sangeeta Mahajan,3 Tatiana Sanses,3 CA Tony Buffington,4 Bradford Fenton,5 Thomas Janicki,3 Sarah Ialacci,2 Elias Veizi,3 Di Zhang,2 Firouz Daneshgari,2,3 Robert Elston,2 Jeffrey Janata2,31The Medical College of Wisconsin, Departments of Neurology and Gastroenterology, Milwaukee, WI, 2Case Western Reserve University, Department of Neurology, Cleveland, OH, 3University Hospitals Case Medical Center, School of Medicine, Cleveland, OH, 4The Ohio State University, Department of Veterinary Clinical Sciences, Columbus, OH, 5Summa Health System, Department of Gynecology, Akron, OH, USABackground and purpose: Interstitial cystitis/bladder pain syndrome (IC/BPS) is relatively common and associated with severe pain, yet effective treatment remains elusive. Research typically emphasized the bladder's role, but given the high presence of systemic comorbidities, the authors hypothesized a pathophysiologic nervous system role. This paper reports the methodology and approach to study the nervous system in women with IC/BPS. The study compares neurologic, urologic, gynecologic, autonomic, gastrointestinal, and psychological features of women with IC/BPS, their female relatives, women with myofascial pelvic pain (MPP), and healthy controls to elucidate the role of central and peripheral processing.Methods and results: In total, 228 women (76 IC/BPS, 76 MPP, 38 family members, and 38 healthy controls) will be recruited. Subjects undergo detailed screening, structured neurologic examination of limbs and pelvis, tender point examination, autonomic testing, electrogastrography, and assessment of comorbid functional dysautonomias. Interpreters are blinded to subject classification. Psychological and stress response characteristics are examined with assessments of stress, trauma history, general psychological function, and stress response quantification. As of December 2012, data collection is completed for 25 healthy controls, 33 IC/BPS ± MPP, eight MPP, and three family members. Recruitment rate is accelerating and strategies emphasize maintaining and encouraging investigator participation in study science, internet advertising, and presentations to pelvic pain support groups.Conclusion: The study represents a comprehensive, interdisciplinary approach to sampling autonomic and psychophysiologic characteristics of women with IC/BPS. Despite divergent opinions on study methodologies based on specialty experiences, the study has proven feasible to date and different perspectives have proved to be one of the greatest study strengths.Keywords: interstitial cystitis, bladder pain syndrome, autonomic nervous system, psychophysiology, pelvic pain, myofascial pain