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Interstitial Cystitis: Examination of the Central Autonomic Network (ICECAN)

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ClinicalTrials.gov Identifier: NCT03008382
Recruitment Status : Recruiting
First Posted : January 2, 2017
Last Update Posted : July 22, 2019
Sponsor:
Collaborators:
NorthShore University HealthSystem
Case Western Reserve University
Information provided by (Responsible Party):
Thomas Chelimsky, Medical College of Wisconsin

Brief Summary:
Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) afflicts 3 to 8 million women in the US. Symptoms of IC/BPS reduce quality of life, suppressing both social well-being and physical function. The chronic pain, voiding dysfunction, sleep deprivation and associated co-morbid conditions interfere with relationships and employment with significant direct (doctor visits, medication, surgery) and indirect (loss of productivity) economic impact, currently exceeding $100 million per year.This proposal aims to move the science of chronic pelvic pain (CPP) from simple associations towards an investigation of cause and effect relationships. The investigators will determine whether the striking changes in autonomic nervous system responsiveness (ANS-R) contribute meaningfully to the pathogenesis of IC/BPS.

Condition or disease Intervention/treatment Phase
Interstitial Cystitis/Painful Bladder Syndrome Myofascial Pelvic Pain Drug: Metoprolol Tartrate Oral Tablet Drug: Placebo Oral Tablet Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Interstitial Cystitis: Examination of the Central Autonomic Network
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Double-Blind Randomized Drug

Participants with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) and/or Myofascial Pelvic Pain (MPP) will be randomized to take 8 weeks of Metoprolol Tartrate Oral Tablet or Placebo Oral Tablet, followed by a 4-Week washout period, and then 8 weeks of Placebo or Metoprolol.

This intervention aims at finding if subjects with IC/BPS have higher baseline HR compared to HCs. After 4 weeks baseline, subjects will receive a bottle with capsules containing 25 mg of metoprolol tartrate or placebo distributed in a double-blind manner by each site's investigational pharmacy. Subjects will start at 25 mg once daily and increase to the goal dose of 25 mg 2/day after one week, if HR has not decreased below 55 bpm at rest. Subjects will report daily rest HR for the first week. The subjects will then washout for 4 weeks and enter crossover in similar manner.

Drug: Metoprolol Tartrate Oral Tablet
Metoprolol is a beta-blocker commonly used for mild blood pressure control, and also commonly used for migraine. Subjects with IC/BPS or MPP will start metoprolol at 25 mg once daily and increase to the goal dose of 25 mg 2/day after one week and continue for 8 weeks total.
Other Name: Metoprolol

Double-Blind Randomized Placebo

Participants with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) and/or Myofascial Pelvic Pain (MPP) will be randomized to take 8 weeks of Metoprolol Tartrate Oral Tablet or Placebo Oral Tablet, followed by a 4-Week washout period, and then 8 weeks of Placebo or Metoprolol.

This intervention aims at finding if subjects with IC/BPS have higher baseline HR compared to HCs. After 4 weeks baseline, subjects will receive a bottle with capsules containing 25 mg of metoprolol tartrate or placebo distributed in a double-blind manner by each site's investigational pharmacy. Subjects will start at 25 mg once daily and increase to the goal dose of 25 mg 2/day after one week, if HR has not decreased below 55 bpm at rest. Subjects will report daily rest HR for the first week. The subjects will then washout for 4 weeks and enter crossover in similar manner.

Drug: Placebo Oral Tablet
Subjects with IC/BPS or MPP will start placebo distributed in a double-blind manner. Subjects will take placebo once daily and increase to the goal dose of 25 mg 2/day after one week and continue for 8 weeks total.
Other Name: Placebo




Primary Outcome Measures :
  1. Correlation between the change in Autonomic Nervous System Responsiveness (ANS-R) and the change in the connectivity between prefrontal cortex (PFC) and periaqueductal gray (PAG) [ Time Frame: 24 Weeks ]
    A linear model with connectivity at 24 weeks as outcome, connectivity at baseline as a covariate and change in ANS-R, demographics such as age and group and the interactions of group with other covariate.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women aged between 18 and 80 years old
  • Healthy controls; Patients diagnosed with Interstitial cystitis/Painful bladder syndrome (IC/BPS) or Myofascial pelvic pain (MPP)
  • IC/BPS - ≥3 months chronic pelvic pain, pressure or discomfort perceived to be related to the urinary bladder accompanied by at least one other urinary symptom like persistent urge to void or frequency. Confusable diseases as the cause of the symptoms must be excluded, particularly recurrent UTI
  • MPP - ≥3 months of non-cyclic continuous pelvic pain unrelated to bladder state and a minimum of 2 of 5 examined pelvic floor TPs scoring at least 4 out of 10 on a numeric rating scale using 2 kg pressure applied with the index finger
  • Provision of informed consent prior to any study specific procedures

Exclusion Criteria:

  • Known nervous system conditions including but not limited to diabetic neuropathy, Parkinson's disease, Alzheimer's disease, multiple sclerosis, strokes, seizures, etc.
  • Baseline heart rate < 50 bpm; blood pressure ≥ 140/80 mmHg at rest or uncontrolled hypertension; or hypertension requiring more than two drugs for control
  • Pregnant, attempting to become pregnant , or breast-feeding
  • Unevaluated hematuria or infection at the time of enrollment
  • Pelvic or bladder neoplasm or infection
  • Severe asthma, inflammatory arthritis, connective tissue or auto-immune disorders
  • 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.)
  • 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). Hormone replacement therapy is acceptable
  • Current, ongoing drug or alcohol abuse
  • Current use of 150 mg or more of narcotics or morphine equivalent (or inconsistent dosages or frequency - varying by > 50 mg morphine equivalent per day)
  • Previous augmentation cystoplasty, cystectomy, cytolysis, or neurectomy. Pelvic surgery in the last 6 months.
  • Any major surgical intervention with general anesthesia in the last 90 days. Current use of anticholinergic medications.
  • Current use of beta-blocker(s).
  • Unwillingness to take a beta blocker and placebo, or planned use of beta-blocker(s) other than study medication.
  • Previous allergic or serious reaction to beta-blockers. Initiation of neural stimulator in the last 30 days.
  • Any on-going or pending medical, health or disability related litigation, or current pursuit of disability.
  • 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).
  • Current participation in another clinical trial that interferes with ICECAN policies and procedures .
  • Investigators, study staff and their immediate families.
  • Inability to speak, read, and understand English.
  • Allergy to adhesives.
  • Initiation of any new treatment class in the last 30 days, or intent to initiate a new class of treatment in the study. Treatment classes include:

    1. Pelvic injection
    2. Pelvic floor therapy
    3. Agents with specific FDA approval for IC/BPS or MPP (e.g., Elmiron)
    4. Anticonvulsants
    5. Tricyclic agents
    6. Intravesical therapy or Botox
    7. Bladder hydrodistention

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03008382


Contacts
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Contact: Crystal O'Hara, BS 414-955-0646 cohara@mcw.edu
Contact: Katherine Sheridan, BS 414-955-0702 ksheridan@mcw.edu

Locations
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United States, Illinois
NorthShore University HealthSystem Recruiting
Evanston, Illinois, United States, 60201
Contact: Katlyn Dillane, BS    847-570-2622    kdillane@northshore.org   
Principal Investigator: Frank Tu, MD         
United States, Ohio
Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44106
Contact: Jeffrey Janata, PhD    216-844-8550    Jeffrey.Janata@UHhospitals.org   
Contact: Bridget Ermlich, RN    216-844-8091    Bridget.Ermlich@UHhospitals.org   
Principal Investigator: Jeffrey Janata, PhD         
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Crystal O'Hara    414-955-0646    cohara@mcw.edu   
Contact: Katherine Sheridan    414-955-0702    ksheridan@mcw.edu   
Principal Investigator: Thomas Chelimsky, MD         
Sponsors and Collaborators
Medical College of Wisconsin
NorthShore University HealthSystem
Case Western Reserve University
Investigators
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Principal Investigator: Thomas Chelimsky, MD Medical College of Wisconsin

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Responsible Party: Thomas Chelimsky, Medical Doctor and Professor of Neurology, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT03008382     History of Changes
Other Study ID Numbers: PRO25031
First Posted: January 2, 2017    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

All participant data will be de-identified before sharing.

Blood and Urine: A portion of the blood plasma/serum and urine will be sent to the University of Pittsburgh for additional related analysis.

Heart Rate Variability (HRV): 24-hour HRV and Active Change of Posture recordings will be sent to Ohio State University for analysis.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code
Time Frame:

The participant's collected data is de-identified immediately. The blood and urine are stored in a freezer until there are enough samples to send out for analysis.

Heart rate recordings are uploaded to a secure MCW storage site and shared for analysis throughout the participant's participation.

Access Criteria:

Participant data will be shared through a secured web dropbox called BOX. BOX access is paid for and controlled by the Medical College of Wisconsin (MCW). The folders containing participant data are password protected and only those who are adding to the folders or performing analysis on collected data are given access through MCW.

MCW's other two recruiting sites, NorthShore University HealthSystem and Case Western Reserve University, are able to add participant data to their own site folders, and each site only has access to their participants' data.

Ohio State University has access to the folder containing participants' heart rate recording to perform analysis.

Blood and Urine samples are deidentified and stored at MCW until a shipment is prepared. They are then sent to the University of Pittsburgh for further analysis.


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Thomas Chelimsky, Medical College of Wisconsin:
Interstitial Cystitis
Pelvic Pain
Additional relevant MeSH terms:
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Cystitis
Cystitis, Interstitial
Pelvic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Metoprolol
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action