Table 2.

Interstitial Cystitis: Elucidation of Psychophysiologic and Autonomic Characteristics (ICEPAC) trial study aims

Broad question	Specific questions	Method
What baseline neurophysiological abnormalities occur in IC/PBS compared to patients with MPP and healthy subjects?	Differentiate bladder and pelvic floor afferent from efferent urogynecological function	a. Voiding diaries (efferent) with pain ratings (afferent) b. Uroflow (efferent) and diagnostic bupivacaine instillation test (afferent) with effect on voiding (efferent) c. Pelvic floor pain and trigger points (efferent) d. Q-tip test for vulvodynia (afferent) e. Evaluation of dysmenorrheal (afferent) and menstrual function (efferent)
	Characterize somatic afferent and autonomic efferent neural function	a. Global screen for autonomic and neurological abnormalities using SFIBS instrument and structured neurological exam b. Evaluate sacral and lumbar nerve root function (afferent and efferent) c. Parasympathetic cardiac function using cardiac response to deep breathing (efferent) d. Sympathetic cardiac and vasomotor function using cardiovascular responses to Valsalva maneuver and to upright tilt table test (efferent) e. Sudomotor sympathetic function using QSART to evaluate post-ganglionic function and thermoregulatory sweat test (efferent)
	Characterize gastrointestinal afferent and efferent function, specifically upper bowel motility	a. Early satiety and gastric compliance using water load test (afferent) b. Gastric electrical activity using electrogastrography (efferent)
What specific developmental, psychological, pain, autonomic and stress responses differentiate IC/PBS, MPP, their family members and healthy controls?	Characterize stress and trauma history in childhood, adulthood	a. Childhood Trauma Questionnaire30 b. Traumatic Life Events Questionnaire31 c. Stressful Life Events Screening Questionnaire32 d. Perceived Stress Scale33
	Characterize psychological symptoms, pain and function	a. General psychiatric screening using the General Health Questionnaire b. Spielberger State–Trait Anxiety Inventory34 c. PTSD Screening Scale35 d. Pennebaker Index of Limbic Languidness (to characterize somatization)36 e. Multidimensional Pain Inventory37 f. Pain Catastrophizing Scale38 g. CES-D Scale39
	Quantify comorbid autonomic disorders	a. ODYSA instrument40
	Characterize stress response	a. Salivary cortisol levels pre/post-autonomic testing b. Trier Social Stress Test with autonomic cardiovascular parameters, body temperature, catecholamines (norepinephrine, epinephrine, dopamine), and endocrine parameters (adrenocorticotropic hormone and adrenocortical hormones)

Abbreviations: CES-D, Center for Epidemiologic Studies Depression; IC/PBS, interstitial cystitis/bladder pain syndrome; MPP, myofascial pelvic pain; ODYSA, Ohio Dysautonomia; PTSD, post-traumatic stress disorder; QSART, quantitative sudomotor axon reflex test; SFIBS, Small Fiber Score.