Status:
SUSPENDED
Low-dose Naltrexone for Bladder Pain Syndrome
Lead Sponsor:
Stanford University
Conditions:
Bladder Pain Syndrome
Interstitial Cystitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Interstitial cystitis/Bladder Pain Syndrome (IC/PBS) is a constellation of symptoms of pelvic discomfort that includes both bladder-related pain as well as urinary frequency, urgency, and nocturia in ...
Eligibility Criteria
Inclusion
- Men and women with non-Hunner and Hunner lesion disease
- Meeting AUA definition of BPS: An unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder associated with lower urinary tract symptoms of greater than 6 weeks duration in the absence of infection or other identifiable cause.
- Stable treatment for 1 month
- 7-day maximum of pain scores at least 4/10 on the numerical rating scale of pain in the bladder/pelvic area. Urinary frequency 8 or higher while awake. Nocturia 2 or higher. BPIC-SS 19.
- Agreement to not take opioids through the duration of the trial
Exclusion
- Substance Use Disorder Diagnosis including Opioid Use Disorder Diagnosis
- Known allergy to naltrexone or naloxone
- Participation in another clinical trial
- Current or planned pregnancy, or breastfeeding
- Chronic pain in another location of the body that is more severe than that related to BPS.
- Any intravesical instillation in last 8 weeks
- If on Elmiron, stable dose for last 3 months
- If on amitriptyline, stable dose for last 3 months
- Any botox within last 6 months
- Treatment for Hunners in the last 6 months
- Any new Interstim settings within last 3 months
- Any new pelvic floor physical therapy in last 12 weeks
- Any change in or new OTC meds over last 2 months.
- Any pain interventions in the preceding 6 weeks (epidural steroid injection, sympathetic block, peripheral nerve block, lumbar medial branch blocks)
- Opioids chronically for IC/BPS in the past unless have been off for 1 year
- Recent short-term (within one week of enrollment) opioid use for flairs
- No documented cystoscopy in the last 5 years
Key Trial Info
Start Date :
October 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04450316
Start Date
October 8 2020
End Date
October 1 2024
Last Update
December 22 2023
Active Locations (1)
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1
Stanford Health Care
Stanford, California, United States, 94304