Interstitial Cystitis: Examination of the Central Autonomic Network

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Medical College of Wisconsin
• Collaborators: Case Western Reserve University; NorthShore University HealthSystem
• Treatments: Metoprolol

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