This study seeks to exploit bladder cannabidiol receptors as a therapeutic drug target by conducting a double-masked, placebo-controlled randomized trial evaluating the effects of vaginal hemp cannabidiol (CBD) suppositories on lower urinary tract symptoms (LUTS), pain severity, and sexual function.
Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) is a chronic inflammatory disease with an insidious course and is detrimental weight to women's quality of life, sexual function, and general health. IC/BPS affects nearly 1.2 million women in the United States and although there are currently six lines of treatment, they lack high level evidence and sufficient efficacy. New therapies are in high demand. As the cannabis industry gains popularity in medicine, research has revealed prevalent expression of cannabinoid receptors in bladder detrusor muscle and urothelium suggesting a novel drug target for IC/BPS. This study seeks to exploit this target by conducting a double-masked, placebo-controlled randomized trial evaluating the effects of vaginal hemp cannabidiol (CBD) suppositories on lower urinary tract symptoms (LUTS), pain severity, and sexual function. Women with diagnosed IC/BPS will be randomized to treatment with a placebo vaginal suppository or a hemp CBD vaginal suppository. We will monitor changes in their LUTS, pain, and sexual function using validated questionnaires. Our goal is to evaluate whether CBD is an effective, low-risk and less invasive treatment option for IC/BPS. Attainment of this goal would demonstrate a potential novel use for CBD in our Urogynecology patient population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Cannabidiol vaginal suppository
Placebo vaginal suppository
University of New Mexico
Albuquerque, New Mexico, United States
Urinary Pain Severity Scores
Compare the efficacy of vaginal CBD suppositories versus vaginal placebo suppositories on pain severity symptoms in IC/BPS patients, as measured by composite pain severity sub-scores of the Genitourinary Pain Index (GUPI) \& Interstitial Cystitis Symptom Index (ICSI). The score ranges from 0-27 composite score with higher scores being consistent with more symptomatic disease.
Time frame: 6 weeks
Urinary Symptom Severity Scores
Compare the efficacy of vaginal CBD suppositories versus vaginal placebo suppositories on lower urinary tract symptoms as measured by the composite urinary severity sub-scores of the Genitourinary Pain Index (GUPI) \& Interstitial Cystitis Symptom Index (ICSI). The score ranges from 0-25 composite score with higher scores being consistent with more symptomatic disease.
Time frame: 6 weeks
Marijuana Urine Drug Test
Evaluate the effect of routine use of vaginal CBD suppositories on a standard over-the-counter marijuana urine drug test
Time frame: 6 weeks
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