Back to resultsIC PaIN Trial: Interstitial Cystitis Pain Improvement With Naltrexone
Primary Purpose
Interstitial Cystitis, Painful Bladder Syndrome, Bladder Pain Syndrome
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
low-dose naltrexone
Placebo oral tablet
Sponsored by
About this trial
This is an interventional treatment trial for Interstitial Cystitis
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- Patients under the age of 18
- Patients with known liver disease, including total bilirubin >1.2, AST> 32, ALT> 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 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.
Sites / Locations
- Center for Pelvic Health at the NorthShore University HealthSystem
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Low-dose naltrexone
Placebo
Arm Description
2mg low-dose naltrexone capsules
Placebo capsules
Outcomes
Primary Outcome Measures
Interstitial Cystitis Symptom Index
The effect of LDN in decreasing symptoms associated with IC/PBS when treating with low-dose naltrexone as scored by the Interstitial Cystitis Symptom Index as compared to placebo. Scores are from 0 to 20, with lower scores indicating less symptoms associated with IC/PBS.
Visual analog scale
The effect of LDN in decreasing pain associated with IC/PBS when treating with low-dose naltrexone as scored by visual analog scale as compared with placebo. Scores are from 0 to 100, with lower scores indicating less pain.
Secondary Outcome Measures
Interstitial Cystitis Problem Index
The decrease in IC/PBS associated problems when treating interstitial cystitis/painful bladder syndrome with low-dose naltrexone as scored by the Interstitial Cystitis Problem Index. Scores are from 0-16, with lower scores indicating a better score, with fewer problems associated with IC/PBS.
Urinary frequency
The change in number of patient voids during the day when comparing LDN against placebo as determined from 24 hour bladder diary performed by patient prior to initiating treatment, and at the conclusion of 6 weeks of treatment.
Nocturia
The change in number of patient voids during at night when comparing LDN against placebo as determined from 24 hour bladder diary performed by patient prior to initiating treatment, and at the conclusion of 6 weeks of treatment.
pelvic pain and urgency/frequency symptoms
The change in pelvic pain and urgency/frequency symptoms as measured on the Pelvic Pain and Urgency/Frequency Patient Symptom Scale. Scores can range from 0-23, with higher scores indicating more severe symptoms associated with IC/PBS.
pelvic pain and urgency/frequency bother
The change in pelvic pain and urgency/frequency bother as measured on the Pelvic Pain and Urgency/Frequency Patient Symptom Scale. Scores can range from 0-12, with higher values corresponding to more bother from IC/PBS symptoms.
Patient perceived changes in quality of life: SF-36
Patient perceived changes in quality of life as measured by the medical outcomes study short form 36 (SF-36). Higher scores indicate a more favorable health status. There are 8 subscales, which when averaged, include a score from 0-100.
Adverse effects
The percentage of patients complaining of adverse effects from LDN including vivid dreams, nightmares, insomnia, GI disturbances such as stomach cramps or diarrhea, agitation, anxiety, flu-like symptoms and headaches.
Medication tolerability
Patient tolerability of low-dose naltrexone using a tolerability survey, as well as instructing the patient to return any remaining medication at the end of the 6 week study period
Change in pain medications
The decrease in use of pain medications while using LDN as determined by a pain medication diary
Full Information
NCT ID
NCT04313972
First Posted
March 16, 2020
Last Updated
April 26, 2023
Sponsor
NorthShore University HealthSystem
1. Study Identification
Unique Protocol Identification Number
NCT04313972
Brief Title
IC PaIN Trial: Interstitial Cystitis Pain Improvement With Naltrexone
Official Title
IC PaIN Trial: Interstitial Cystitis Pain Improvement With Naltrexone, the Effect of Low Dose Naltrexone on Symptoms and Pain of Patients With Interstitial Cystitis/Painful Bladder Syndrome a Randomized Placebo-controlled Prospective Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 7, 2021 (Actual)
Primary Completion Date
January 23, 2023 (Actual)
Study Completion Date
February 23, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NorthShore University HealthSystem
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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 urinary tract infection or other identifiable causes. IC/PBS often coexists with other chronic pain syndromes, such as irritable bowel syndrome, chronic fatigue syndrome, and fibromyalgia.
Several treatments exist for IC/PBS; some are not effective, others are time consuming for patients to receive, some can take weeks to months before they become effective, and many have risks associated with them. Low-dose naltrexone (LDN) has demonstrated improvement of symptoms in conditions associated with IC/PBS. LDN is defined as less than 5mg of naltrexone. Some adverse effects have been reported with LDN, the most common are vivid dreams, nightmares, and insomnia.
The investigators hypothesis LDN will have greater than 30% reduction in symptoms as defined by the Interstitial Cystitis Symptom Index in patients diagnosed with IC/PBS from baseline when compared to placebo. The 30% reduction in pain is a standard outcome measure in the pain literature. This improvement has been seen in prior studies where LDN was used to treat pain syndromes.
This will be a randomized double-blinded placebo-controlled prospective trial. Patients meeting diagnostic criteria for IC/PBS by American Urologic Association (AUA) guidelines will be eligible, and then must then meet all applicable inclusion and exclusion criteria. Study participants will sign a consent, complete several questionnaires, give a blood sample to measure liver function tests, and once at home, complete a 24-hour bladder diary.
Participants will be randomized to receive either placebo or study medication. Participants will be instructed to take one capsule nightly for two weeks, then increase to two capsules nightly for four weeks. They will be given a log to record the date and time they take the medication. All study participants will also receive first-line behavioral therapy for IC/PBS of a bladder diet and bladder drills.
After six weeks, participants will complete a second bladder diary. They will then complete the exit study questionnaires, have a second liver function test, return any unused medication, and meet with their doctor to discuss conventional treatment options for IC/PBS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Cystitis, Painful Bladder Syndrome, Bladder Pain Syndrome, Low Dose Naltrexone, Low-dose Naltrexone, Naltrexone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low-dose naltrexone
Arm Type
Experimental
Arm Description
2mg low-dose naltrexone capsules
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsules
Intervention Type
Drug
Intervention Name(s)
low-dose naltrexone
Intervention Description
2mg of low-dose naltrexone nightly for 2 weeks, then 4mg of low-dose naltrexone nightly for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Intervention Description
1 capsule nighty for 2 weeks, then 2 capsules nightly for 4 weeks
Primary Outcome Measure Information:
Title
Interstitial Cystitis Symptom Index
Description
The effect of LDN in decreasing symptoms associated with IC/PBS when treating with low-dose naltrexone as scored by the Interstitial Cystitis Symptom Index as compared to placebo. Scores are from 0 to 20, with lower scores indicating less symptoms associated with IC/PBS.
Time Frame
six weeks
Title
Visual analog scale
Description
The effect of LDN in decreasing pain associated with IC/PBS when treating with low-dose naltrexone as scored by visual analog scale as compared with placebo. Scores are from 0 to 100, with lower scores indicating less pain.
Time Frame
six weeks
Secondary Outcome Measure Information:
Title
Interstitial Cystitis Problem Index
Description
The decrease in IC/PBS associated problems when treating interstitial cystitis/painful bladder syndrome with low-dose naltrexone as scored by the Interstitial Cystitis Problem Index. Scores are from 0-16, with lower scores indicating a better score, with fewer problems associated with IC/PBS.
Time Frame
six weeks
Title
Urinary frequency
Description
The change in number of patient voids during the day when comparing LDN against placebo as determined from 24 hour bladder diary performed by patient prior to initiating treatment, and at the conclusion of 6 weeks of treatment.
Time Frame
six weeks
Title
Nocturia
Description
The change in number of patient voids during at night when comparing LDN against placebo as determined from 24 hour bladder diary performed by patient prior to initiating treatment, and at the conclusion of 6 weeks of treatment.
Time Frame
six weeks
Title
pelvic pain and urgency/frequency symptoms
Description
The change in pelvic pain and urgency/frequency symptoms as measured on the Pelvic Pain and Urgency/Frequency Patient Symptom Scale. Scores can range from 0-23, with higher scores indicating more severe symptoms associated with IC/PBS.
Time Frame
six weeks
Title
pelvic pain and urgency/frequency bother
Description
The change in pelvic pain and urgency/frequency bother as measured on the Pelvic Pain and Urgency/Frequency Patient Symptom Scale. Scores can range from 0-12, with higher values corresponding to more bother from IC/PBS symptoms.
Time Frame
six weeks
Title
Patient perceived changes in quality of life: SF-36
Description
Patient perceived changes in quality of life as measured by the medical outcomes study short form 36 (SF-36). Higher scores indicate a more favorable health status. There are 8 subscales, which when averaged, include a score from 0-100.
Time Frame
six weeks
Title
Adverse effects
Description
The percentage of patients complaining of adverse effects from LDN including vivid dreams, nightmares, insomnia, GI disturbances such as stomach cramps or diarrhea, agitation, anxiety, flu-like symptoms and headaches.
Time Frame
6 weeks
Title
Medication tolerability
Description
Patient tolerability of low-dose naltrexone using a tolerability survey, as well as instructing the patient to return any remaining medication at the end of the 6 week study period
Time Frame
6 weeks
Title
Change in pain medications
Description
The decrease in use of pain medications while using LDN as determined by a pain medication diary
Time Frame
6 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
Patients under the age of 18
Patients with known liver disease, including total bilirubin >1.2, AST> 32, ALT> 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 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.
Facility Information:
Facility Name
Center for Pelvic Health at the NorthShore University HealthSystem
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Links:
URL
https://www-uptodate-com.proxy.uchicago.edu/contents/amitriptyline-drug-
Description
Amitriptyline: Drug information. Accessed 10/29/2019
URL
https://www-uptodate-com.proxy.uchicago.edu/contents/management-of-interstitial-cystitis-bladder-pain-syndrome?source=history_widget#H285129
Description
Management of interstitial cystitis/bladder pain syndrome. Uptpdate. Accessed 12/5/2019
Learn more about this trial
IC PaIN Trial: Interstitial Cystitis Pain Improvement With Naltrexone
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