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Trial record 14 of 48 for:    Open Studies | "Cystitis"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Case Western Reserve University
Sponsor:
Information provided by (Responsible Party):
Thomas Chelimsky, Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT01616992
First received: June 8, 2012
Last updated: February 27, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Interstitial Cystitis/Painful Bladder Syndrome
Myofascial Pelvic Pain
Drug: Bupivacaine

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Interstitial Cystitis: Elucidation of the Psychophysiologic and Autonomic

Resource links provided by NLM:


Further study details as provided by Case Western Reserve University:

Primary Outcome Measures:
  • Interstitial Cystitis [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Clinical Assessment

  • Myofascial Pelvic Pain [ Time Frame: 1 Month ] [ Designated as safety issue: No ]
    Clinical Assessment


Secondary Outcome Measures:
  • Depression Symptoms [ Time Frame: 1 Month ] [ Designated as safety issue: No ]
    Questionnaire Assessment of Symptoms

  • Stress Symptoms [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Questionnaire Assessment


Estimated Enrollment: 240
Study Start Date: September 2009
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Interstitial Cystitis Drug: Bupivacaine
20 ML dose of 0.75% Bupivacaine Instillation (into bladder) 1 time during second study visit.
Myofascial Pelvic Pain Drug: Bupivacaine
20 ML dose of 0.75% Bupivacaine Instillation (into bladder) 1 time during second study visit.
Healthy
First Degree Relative

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Criteria

General exclusion criteria for all IC/PBS and MPP patients, their siblings, and normal subjects will include presence of:

  1. Currently attempting to become pregnant, pregnant (pregnancy test will be required) or breast feeding
  2. Hematuria (? this can occur in IC) or infection on urinalysis
  3. Recurrent urinary tract infections (> 3 culture documented episodes within the previous 12 months)
  4. Pelvic or bladder neoplasm or infection
  5. Inflammatory arthritis, connective tissue or auto-immune disorder
  6. 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.).
  7. Neuropathy, central nervous system disorder (e.g., Parkinson's Disease, Alzheimer's, MS, stroke, etc)
  8. Treatment with a drug or medical device within the previous 30 days that has not received regulatory approval
  9. Use of hormones (except insulin, thyroid replacement or oral contraceptives, which will be carefully documented)
  10. Regular use of opiods
  11. Allergy to lidocaine
  12. Inability to stop use of autonomically active or pro-kinetic (gastrointestinal motility modifying) agents for a minimum of 5 half-lives prior to testing
  13. Current substance abuse or > 10 alcoholic beverages per week
  14. Any major surgical intervention with general anesthesia in the last 90 days
  15. Any on-going or pending medical, health or disability related litigation, or current pursuit of disability
  16. Any condition that in the judgment of the investigator and the internal advisory panel would interfere with the patient's ability to provide informed consent, comply with study instructions, place the patient at increased risk, or which would clearly confound the interpretation of the study results (specific reason will be documented) 17.Investigators, study staff and their immediate families 18.Inability to speak English

19) Previously completed or withdrawn from this study

Normal controls and siblings: Aged-matched healthy female subjects will be recruited by nomination by patients and advertisement. A history and physical will be obtained by a physician, and controls will be required to have no history, symptoms or signs of (exclusion criteria):

  1. FM or CFS (unexplained fatigue for a period of 6 months or more)
  2. IC/PBS, MPP or chronic pelvic discomfort or chronic pain disorder of any type.
  3. One of the other ODYSA dysautonomias

IC/PBS Patients - The diagnosis of IC/PBS will be made using most current NIDDK criteria. Exclusion criteria:

  1. Intravesical therapy or bladder hydrodistention within the previous 90 days
  2. Initiation of pentosan polysulfate sodium (Elmiron) within the previous 90 days
  3. Previous augmentation cystoplasty, cystectomy or cytolysis, neurectomy (i.e., hypogastric nerve plexus ablation) or implanted neural stimulator which is functionally "on", in active use, or unable to be turned functionally off throughout the study period.

MPP Patients - Inclusion Criteria

  1. CPP > 3 months duration, with pain ranked > 3/10 by oral analog scale
  2. Presence of 1 or more palpable trigger points on transvaginal and/or transrectal examination of the pelvic floor, which reproduces the pain for which they are seeking medical care.

Exclusion criteria:

  1. Pelvic surgery within the last 12 months
  2. Pelvic injection with the last 90 days
  3. Presence of IC/PBS by the current NIDDK criteria
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01616992

Contacts
Contact: Sarah M Ialacci 216-368-2684 sarah.ialacci@uhhospitals.org
Contact: Megan Findling 216-368-0783 megan.findling@uhhospitals.org

Locations
United States, Ohio
Summa Health System Recruiting
Akron, Ohio, United States, 44304
Contact: Sara Jane Salstrom    330-375-4293    salstros@summahealth.org   
Sub-Investigator: Bradford Fenton, MD         
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Principal Investigator: Jeffrey Janata, PhD         
Sponsors and Collaborators
Case Western Reserve University
Investigators
Principal Investigator: Thomas C Chelimsky, MD Medical College of Wisconsin
Principal Investigator: Jeffrey Janata, PhD University Hospital Case Medical Center
  More Information

No publications provided

Responsible Party: Thomas Chelimsky, Professor of Neurology, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT01616992     History of Changes
Other Study ID Numbers: R01DK083538
Study First Received: June 8, 2012
Last Updated: February 27, 2013
Health Authority: United States: National Institutes of Health

Additional relevant MeSH terms:
Cystitis
Cystitis, Interstitial
Pelvic Pain
Pain
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Bupivacaine
Anesthetics
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014