Low-dose Naltrexone for Bladder Pain Syndrome

  • STATUS
    Recruiting
  • End date
    Oct 27, 2023
  • participants needed
    40
  • sponsor
    Stanford University
Updated on 27 July 2022
discomfort
chronic pain
pain syndromes
pelvic pain
naltrexone
lower urinary tract symptoms
nocturia
bladder pain
cystitis
fibromyalgia
hunner's ulcer
pain disorders

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 the absence of an identifiable etiology that affects likely more than 5.4 million patients in the United States. There is a significant overlap in patients with IC/PBS and those with fibromyalgia and chronic pelvic pain syndrome. Low-dose naltrexone (LDN) has been shown to be effective for the treatment of chronic pain conditions.

The primary aim of this study is to evaluate if LDN improves pain scores and lower urinary tract symptoms in patients with IC/PBS. A secondary aim is to show that it has a low adverse event profile.

Details
Condition Bladder Pain Syndrome, Interstitial Cystitis
Treatment Placebo, naltrexone
Clinical Study IdentifierNCT04450316
SponsorStanford University
Last Modified on27 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
-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 Criteria

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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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