Interstitial Cystitis: Examination of the Central Autonomic Network (ICECAN)
Interstitial Cystitis/Painful Bladder Syndrome, Myofascial Pelvic Pain
About this trial
This is an interventional other trial for Interstitial Cystitis/Painful Bladder Syndrome focused on measuring Interstitial Cystitis, Pelvic Pain
Eligibility 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:
- Pelvic injection
- Pelvic floor therapy
- Agents with specific FDA approval for IC/BPS or MPP (e.g., Elmiron)
- Anticonvulsants
- Tricyclic agents
- Intravesical therapy or Botox
- Bladder hydrodistention
Sites / Locations
- NorthShore University HealthSystem
- Medical College of Wisconsin
Arms of the Study
Arm 1
Arm 2
Other
Other
Double-Blind Randomized Drug
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.
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.