Low-dose Naltrexone for Bladder Pain Syndrome: A Randomized Placebo-controlled Prospective Pilot Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- The proportion of subjects in the LDN and placebo groups that are responders with greater than 20% reductions in 7-day average of worst daily Numeric Rating Scale of Pain scores after 8 weeks of treatment.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants will be randomized on a 1:1 ratio to either LDN or placebo. The randomization sequence will be logged by the study coordinator in a REDCap randomization log blinded to other research staff and clinical team and outcome assessors.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Agreement to not take opioids through the duration of the trial
排除标准
- •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
研究组 & 干预措施
Placebo
Placebo tablet (sugar-pill) to be taken one hour prior to bedtime nightly for 8 weeks.
干预措施: Placebo (Drug)
Low-dose naltrexone
4.5mg of naltrexone to be taken one hour prior to bedtime nightly for 8 weeks.
干预措施: Naltrexone (Drug)
结局指标
主要结局
The proportion of subjects in the LDN and placebo groups that are responders with greater than 20% reductions in 7-day average of worst daily Numeric Rating Scale of Pain scores after 8 weeks of treatment.
时间窗: Will compare pre-intervention to week 8.
The Numeric Rating Scale of Pain
时间窗: 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.
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.
次要结局
- Change in Brief Pain Inventory Score(At pre-intervention to week 8.)
- Change in average frequency and nocturia during a 5-day voiding diary(At pre-intervention to week 8.)
- Change in O'Leary Sant symptom scores(At pre-intervention to week 8)
- Change in O'Leary Sant Problem Indices scores(At pre-intervention to week 8)
- Change in PROMIS sleep dysfunction score(At pre-intervention to week 8)
- Change in PROMIS pain interference score(At pre-intervention to week 8)
- Change in PROMIS fatigue score(At pre-intervention to week 8)
- Change in Global response assessment scale score(At pre-intervention to week 8)
- Change in PROMIS pain behavior score(At pre-intervention to week 8)
- Change in PROMIS physical function score(At pre-intervention to week 8)
- Change in PROMIS anxiety score(At pre-intervention to week 8)
- Change in PROMIS depression score(At pre-intervention to week 8)
- Change in Bladder Pain/Interstitial Cystitis Symptom Score(At pre-intervention to week 8)
- Change in PROMIS Sleep-Related Impairment(At pre-intervention to week 8)
- Change in Brief Pain Inventory Score(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(Prior to treatment and after 8 weeks of treatment.)
- Change in O'Leary Sant Symptom Scores(At pre-intervention to week 8)
- Change in O'Leary Sant Problem Indices Scores(At pre-intervention to week 8)
- Change in Global Response Assessment Scale Score(At pre-intervention to week 8)
- Change in PROMIS Pain Behavior Score(At pre-intervention to week 8)
- Change in PROMIS Physical Function Score(At pre-intervention to week 8)
- Change in PROMIS Sleep Dysfunction Score(At pre-intervention to week 8)
- Change in PROMIS Pain Interference Score(At pre-intervention to week 8)
- Change in PROMIS Fatigue Score(At pre-intervention to week 8)
- Change in PROMIS Anxiety Score(At pre-intervention to week 8)
- Change in PROMIS Depression Score(At pre-intervention to week 8)
研究者
Jennifer Hah
Assistant Professor
Stanford University