Status:
TERMINATED
IC PaIN Trial: Interstitial Cystitis Pain Improvement With Naltrexone
Lead Sponsor:
Endeavor Health
Conditions:
Interstitial Cystitis
Painful Bladder Syndrome
Eligibility:
FEMALE
18-110 years
Phase:
PHASE4
Brief Summary
Interstitial cystitis/painful bladder syndrome (IC/PBS) is a debilitating condition with symptoms of urinary urgency, frequency, nocturia (waking up at night to void), and pain, without evidence of ur...
Eligibility Criteria
Inclusion
- Patients aged eighteen and older
- Meet criteria for IC/PBS as defined by the American Urology Association as "an unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms or more than six weeks duration, in the absence of infection or other identifiable causes" (8)
- Newly diagnosed and treatment naïve for IC/PBS or previously diagnosed with IC/PBS, but who have no received treatment in the past four weeks. Patient who use anti-inflammatory medication on an as needed basis in the four weeks prior to the study will be included.
- Have had a cystoscopy in the last 6 months prior to study entry to rule out confounding conditions
- English speaking
- Working telephone number
- Able to provide a blood sample to evaluate liver enzymes
- Able to attend research visits
Exclusion
- Patients under the age of 18
- Patients with known liver disease, including total bilirubin \>1.2, AST (aspartate aminotransferase) \> 32, ALT (alanine transaminase) \> 54
- Patients with known kidney disease
- Patients who have thyroid disease and who are taking thyroid replacement medications
- Patients with known neurologic disease affecting bladder function
- Patients with known bladder or urethral cancer
- Patients with bladder, urethral, or ureteral calculi
- Patients who have had a positive urine culture or a clinical UTI (Urinary Tract Infection) in the past 6 weeks
- Patients who are currently pregnant or breast feeding (15)
- Patients who are actively using opioid analgesics
- Patients with moderate-severe alcohol use disorder
- Patients who are actively using sleep aids
- Patients who are regularly using anti-inflammatory medications, such as daily Celebrex for arthritis. Those who use an anti-inflammatory medication on an as needed basis may use the medication prior to enrollment in the study.
- Patients who have had a known adverse reaction to naltrexone
- Patients who are acutely ill
- Patients who are diagnosed with a significant psychological comorbidity that would interfere with study participation (32)
- Patients who have had a bladder instillation or had oral medical treatment for IC/PBS in the past four weeks.
- Patients diagnosed with other chronic pelvic pain syndromes, such as endometriosis
- Patients who are unable to swallow pills/capsules
- Patients who have had previous treatment with low-dose naltrexone
- Patients who have previously scheduled surgeries or procedure during the study time period that would require analgesia.
- Patients who are sexually active and of childbearing potential who are unwilling to use an established and reliable form of contraception for the duration of the study.
- Patients who are unwilling to have a serum blood test to assess serum transaminases and serum bilirubin.
Key Trial Info
Start Date :
September 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2023
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04313972
Start Date
September 7 2021
End Date
February 23 2023
Last Update
March 7 2025
Active Locations (1)
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1
Center for Pelvic Health at the NorthShore University HealthSystem
Skokie, Illinois, United States, 60076