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

NCT01616992 | Completed DMC

• 1 other identifier: R01DK083538
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Interstitial Cystitis/Painful Bladder Syndrome; Myofascial Pelvic Pain

Outcome Measures

Primary Outcomes (2)

• Interstitial Cystitis

  Clinical Assessment

  1 month

• Myofascial Pelvic Pain

  Clinical Assessment

  1 Month

Secondary Outcomes (2)

• Depression Symptoms

  1 Month

• Stress Symptoms

  1 month

Study Arms (4)

Interstitial Cystitis

Drug: Bupivacaine

Myofascial Pelvic Pain

Drug: Bupivacaine

Healthy

First Degree Relative

Interventions

Bupivacaine DRUG

20 ML dose of 0.75% Bupivacaine Instillation (into bladder) 1 time during second study visit.

Interstitial Cystitis; Myofascial Pelvic Pain

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

• Currently attempting to become pregnant, pregnant (pregnancy test will be required) or breast feeding
• Hematuria (? this can occur in IC) or infection on urinalysis
• Recurrent urinary tract infections (\> 3 culture documented episodes within the previous 12 months)
• Pelvic or bladder neoplasm or infection
• Inflammatory arthritis, connective tissue or auto-immune disorder
• Evidence of unstable medical disorder, such as kidney (rising creatinine, or end-stage renal failure) or liver impairment (rising AST or ALT, or end-stage with coagulopathy), poorly controlled significant cardiovascular (CHF), respiratory, endocrine (diabetes - A1c \> 9 - or untreated thyroid dysfunction) or uncontrolled psychiatric illness (such as untreated depression, psychosis, etc.).
• Neuropathy, central nervous system disorder (e.g., Parkinson's Disease, Alzheimer's, MS, stroke, etc)
• Treatment with a drug or medical device within the previous 30 days that has not received regulatory approval
• Use of hormones (except insulin, thyroid replacement or oral contraceptives, which will be carefully documented)
• Regular use of opiods
• Allergy to lidocaine
• Inability to stop use of autonomically active or pro-kinetic (gastrointestinal motility modifying) agents for a minimum of 5 half-lives prior to testing
• Current substance abuse or \> 10 alcoholic beverages per week
• Any major surgical intervention with general anesthesia in the last 90 days
• Any on-going or pending medical, health or disability related litigation, or current pursuit of disability

Sponsors & Collaborators

• Case Western Reserve University: lead

Study Sites (2)

Summa Health System

Akron, Ohio, 44304, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

• Williams DP, Chelimsky G, McCabe NP, Koenig J, Singh P, Janata J, Thayer JF, Buffington CA, Chelimsky T. Effects of Chronic Pelvic Pain on Heart Rate Variability in Women. J Urol. 2015 Nov;194(5):1289-94. doi: 10.1016/j.juro.2015.04.101. Epub 2015 May 9.

  PMID: 25963185 DERIVED

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Thomas C Chelimsky, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

• Jeffrey Janata, PhD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: June 8, 2012
• First Posted: June 12, 2012
• Study Start: September 1, 2009
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 4, 2015

Record last verified: 2015-02

Locations

US (2)