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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01616992
Date of registration: 08/06/2012
Prospective Registration: No
Primary sponsor: Case Western Reserve University
Public title: Interstitial Cystitis: Elucidation of the Psychophysiologic and Autonomic Characteristics (ICEPAC) Study ICEPAC
Scientific title: Interstitial Cystitis: Elucidation of the Psychophysiologic and Autonomic
Date of first enrolment: September 2009
Target sample size: 200
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT01616992
Study type:  Observational
Study design:  Observational Model: Case Control, Time Perspective: Prospective  
Phase:  N/A
Countries of recruitment
United States
Contacts
Name:     Jeffrey Janata, PhD
Address: 
Telephone:
Email:
Affiliation:  University Hospital Case Medical Center
Name:     Thomas C Chelimsky, MD
Address: 
Telephone:
Email:
Affiliation:  Medical College of Wisconsin
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Female
Health Condition(s) or Problem(s) studied
Interstitial Cystitis/Painful Bladder Syndrome
Myofascial Pelvic Pain
Intervention(s)
Drug: Bupivacaine
Primary Outcome(s)
Interstitial Cystitis [Time Frame: 1 month]
Myofascial Pelvic Pain [Time Frame: 1 Month]
Secondary Outcome(s)
Stress Symptoms [Time Frame: 1 month]
Depression Symptoms [Time Frame: 1 Month]
Secondary ID(s)
R01DK083538
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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