title: Interstitial Cystitis - Elucidation of Psychophysiologic and Autonomic Characteristics (the ICEPAC Study): design and methods.
abstract: OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: The Medical College of Wisconsin, Departments of Neurology and Gastroenterology, Milwaukee, WI, USA.
authors.forename: Thomas
authors.initials: T
authors.lastname: Chelimsky
authors.affiliation: The Medical College of Wisconsin, Departments of Neurology and Gastroenterology, Milwaukee, WI, USA.
authors.forename: Gisela
authors.initials: G
authors.lastname: Chelimsky
authors.affiliation: Case Western Reserve University, Department of Neurology, Cleveland, OH, USA.
authors.forename: N Patrick
authors.initials: NP
authors.lastname: McCabe
authors.affiliation: University Hospitals Case Medical Center, School of Medicine, Cleveland, OH, USA.
authors.forename: Megan
authors.initials: M
authors.lastname: Louttit
authors.affiliation: University Hospitals Case Medical Center, School of Medicine, Cleveland, OH, USA.
authors.forename: Adonis
authors.initials: A
authors.lastname: Hijaz
authors.affiliation: University Hospitals Case Medical Center, School of Medicine, Cleveland, OH, USA.
authors.forename: Sangeeta
authors.initials: S
authors.lastname: Mahajan
authors.affiliation: University Hospitals Case Medical Center, School of Medicine, Cleveland, OH, USA.
authors.forename: Tatiana
authors.initials: T
authors.lastname: Sanses
authors.affiliation: The Ohio State University, Department of Veterinary Clinical Sciences, Columbus, OH, USA.
authors.forename: Ca Tony
authors.initials: CT
authors.lastname: Buffington
authors.affiliation: Summa Health System, Department of Gynecology, Akron, OH, USA.
authors.forename: Bradford
authors.initials: B
authors.lastname: Fenton
authors.affiliation: University Hospitals Case Medical Center, School of Medicine, Cleveland, OH, USA.
authors.forename: Thomas
authors.initials: T
authors.lastname: Janicki
authors.affiliation: Case Western Reserve University, Department of Neurology, Cleveland, OH, USA.
authors.forename: Sarah
authors.initials: S
authors.lastname: Ialacci
authors.affiliation: University Hospitals Case Medical Center, School of Medicine, Cleveland, OH, USA.
authors.forename: Elias
authors.initials: E
authors.lastname: Veizi
authors.affiliation: Case Western Reserve University, Department of Neurology, Cleveland, OH, USA.
authors.forename: Di
authors.initials: D
authors.lastname: Zhang
authors.affiliation: Case Western Reserve University, Department of Neurology, Cleveland, OH, USA ; University Hospitals Case Medical Center, School of Medicine, Cleveland, OH, USA.
authors.forename: Firouz
authors.initials: F
authors.lastname: Daneshgari
authors.affiliation: Case Western Reserve University, Department of Neurology, Cleveland, OH, USA.
authors.forename: Robert
authors.initials: R
authors.lastname: Elston
authors.affiliation: Case Western Reserve University, Department of Neurology, Cleveland, OH, USA ; University Hospitals Case Medical Center, School of Medicine, Cleveland, OH, USA.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Janata
keywords: autonomic nervous system; bladder pain syndrome; interstitial cystitis; myofascial pain; pelvic pain; psychophysiology