Low-dose Naltrexone for Bladder Pain Syndrome

Phase 2TerminatedNCT04450316

Stanford University29 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Bladder Pain Syndrome Interstitial Cystitis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 * 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 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

Outcomes

Primary Outcomes

The Numeric Rating Scale of Pain

The Numeric Rating Scale (NRS) of Pain uses an 11-point likert scale. Scores ranges from a minimum of 0 (No pain) to a maximum of 10 (Worst Pain Imaginable). Higher scores indicate greater pain intensityThe proportion of subjects in the LDN and placebo groups that are responders with greater than 20% reductions in the worst daily Numeric Rating Scale of Pain scores after 8 weeks of treatment.

Time frame: Will compare a 7-day average of pre-intervention Numeric Rating Scale of Pain scores to the 7-day average of post-intervention Numeric Rating Scale of Pain Scores after week 8 of treatment.

Secondary Outcomes

Change in Brief Pain Inventory Score

The Brief Pain Inventory score ranges from a minimum of 0 to a maximum of 10, with higher scores indicating worse pain intensity.

Time frame: Comparing the average of 7 days of scores reported pre-intervention and the average of 7 days of score reported 8 weeks after intervention.

Voiding Diary

The Voiding Diary assesses the frequency and amount an individual voids over the course of a 24 hour period. Study subjects indicate number of times they void in an hour and how much they urinate. Study subjects complete daily voiding diaries over the course of a 7 day period before and after the intervention period. Voiding frequency in a 24 hour period was assessed with possible range between 0 to 24 times per day. Participants were asked to complete a 7-day voiding diary at baseline and after 8 weeks of treatment. The average voiding frequency at baseline was compared to follow-up after 8 weeks of treatment.

Time frame: Prior to treatment and after 8 weeks of treatment.

Change in Bladder Pain/Interstitial Cystitis Symptom Score

Total score ranges from 0 to 38. Higher values represent more symptoms of bladder pain associated with interstitial cystitis.