Interstitial Cystitis: Elucidation of the Psychophysiologic and Autonomic Characteristics (ICEPAC) Study
Condition: Interstitial Cystitis/Painful Bladder Syndrome; Myofascial Pelvic Pain
MeSH terms: Cystitis; Cystitis, Interstitial; Pelvic Pain
Study type: Observational

Summary: 
      Interstitial cystitis/painful bladder syndrome (IC/PBS) causes severe bladder pain and
      extensive disability in a large group of women int he prime of their productive lives.
      Extensive study of the bladder itself has uncovered many abnormalities, but the investigators
      do not know if these are the cause or result of the disorder. None of these has led to any
      real long-term progress in treatment, so far. The investigators have found that other
      autonomic disorders often occur in both the patients themselves and in the family members of
      patients with IC/PBS. The investigators therefore propose to determine whether the main
      abnormality in IC/PBS actually lies in the autonomic nervous system, rather than the bladder.
      The investigators will do this through careful measurements of autonomic function and
      sensation in patients who have IC/PBS, both at rest, and under controlled psychological
      stress. The investigators will compare their measurements to patients with myofascial pelvic
      pain, to know which abnormalities are truly linked to IC/PBS, and which simply reflect the
      presence of pelvic pain.
    

Detailed description: 
      The investigators primary hypothesis is that IC/PBS is a member of a larger family of
      disorders sharing aberrant central autonomic and sensory response to stress, pain or threat.
      These disorders appear to share a common vulnerability that seems to be conferred during
      development, and symptoms of these disorders usually are first manifested in response to an
      environmental trigger. This proposal aims to compare the neural, psychological, and endocrine
      phenotypes that characterize patients with IC/PBS with those of patients suffering myofascial
      pelvic pain (MPP) syndrome, an chronic pelvic pain distinct from IC/PBS, age-matched, healthy
      controls, and first degree relatives. These studies are designed to identify which levels of
      the neuraxis are impaired, both in the basal state, and in response to a well-characterized
      psychosocial stressor.

      Aim 1: To differentiate the specific baseline neurophysiological abnormalities that occur in
      IC/PBS from those present in patients with MPP and healthy subjects, specifically:

      1a: Bladder and pelvic floor afferent and efferent urogynecological function: (1) voiding
      diaries (efferent) modified to include void-state related numeric rating scales for pain
      (afferent); Uroflow measurements (efferent), and a double-blind placebo-controlled evaluation
      of the diagnostic lidocaine instillation test (afferent) with impact on voiding function
      (efferent); (2) semi-quantitative evaluation of pelvic floor function and identification of
      myofascial trigger points (efferent), including inter-observer validation of a standardized
      semi-quantitative examination (afferent); (3) quantitative Q-tip test for vulvodynia
      (afferent) (4) evaluation of dysmenorrhea (afferent) and menstrual function (efferent).

      1b: somatic afferent and autonomic efferent neural function, specifically: (1) global screen
      for autonomic and neurological abnormalities through the established Small Fiber Score
      Instrument (SFIBS) questionnaire and structured neurological examination (afferent and
      efferent); (2) specific evaluation of sacral and lumbar nerve root function through a focused
      neurological examination (afferent and efferent); (3) parasympathetic cardiac function
      through the cardiac response to deep breathing (efferent); (4) sympathetic cardiac and
      vasomotor functions through the cardiovascular responses to the Valsalva maneuver and to an
      upright tilt table test (efferent); (5) sudomotor sympathetic function through the
      quantitative sudomotor axon reflex test (QSART) that evaluates post-ganglionic function
      (specifically abnormal in autonomic neuropathies) and through a thermoregulatory sweat test
      (efferent).

        1. c: gastrointestinal afferent and efferent function, specifically upper bowel motility
           with established methods: (1) early satiety & gastric compliance by water load test
           (afferent). (2) gastric electrical activity through electrogastrography (efferent).

           Aim 2: To determine the specific developmental, psychiatric, pain, autonomic, and stress
           response characteristics common to IC/PBS and their family members, that differ from MPP
           and healthy subjects through:

        2. a: Stress and trauma history in early childhood and adulthood.

      2b: Psychiatric screening and psychometric quantitation of psychological symptoms, pain and
      function.

      2c: Quantitation of associated co-morbid autonomic disorders through the ODYSA questionnaire.

      2d: Salivary cortisol levels immediately prior to autonomic testing (anticipatory stress) and
      after a period of relaxation once the test is finished, in conjunction with a stress
      self-assessment inventory.

      2e: Performance of the Trier test on a subset of patients and controls, with measurement of
      autonomic cardiovascular parameters, body temperature, catecholamine concentrations
      (norepinephrine, epinephrine, dopamine) and endocrine parameters: ACTH and adrenocortical
      hormones.
    

Intervention name(s): Bupivacaine
Intervention type(s): Drug
Intervention description(s): 20 ML dose of 0.75% Bupivacaine Instillation (into bladder) 1 time during second study visit.
Intervention MeSH terms: Bupivacaine
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The patient population will be composed of four subject groups:

        Group I: This group will consist of female IC/PBS patients (n = 76) Group II: This group
        will consist of female siblings of patients (n = 38) Group III: This group will consist of
        female MPP patients (n = 76) Group IV: This group will consist of healthy female control
        subjects (n = 38) Female subjects ages 18-80 will be recruited.