Interstitial Cystitis: Examination of the Central Autonomic Network

• Register: ClinicalTrials.gov
• Last refreshed on: 20 February 2023
• Main ID: NCT03008382
• Date of registration: 28/12/2016
• Prospective Registration: Yes
• Primary sponsor: Medical College of Wisconsin
• Public title: Interstitial Cystitis: Examination of the Central Autonomic Network ICECAN
• Scientific title: Interstitial Cystitis: Examination of the Central Autonomic Network
• Date of first enrolment: March 1, 2017
• Target sample size: 80
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03008382
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Thomas Chelimsky, MD
• Affiliation: Medical College of Wisconsin

Key inclusion & exclusion 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



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: Placebo Oral Tablet

Drug: Metoprolol Tartrate Oral Tablet

Primary Outcome(s)

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]

Secondary ID(s)

PRO25031

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Case Western Reserve University

NorthShore University HealthSystem