About this trial
The purpose of this study is to assess the use of peppermint oil as a treatment for Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Women ages 18-65 years old
Diagnosed with IC/BPS for at least one month prior to study enrollment
Disqualifiers
Culture proven urinary tract infection within 1 month of randomization
Gross hematuria
Currently pregnant or breastfeeding
Unable to speak and read English
Trial design
Parallel
Treatments tested in this trial
Peppermint oil
DrugEnteric coated peppermint oil taken by mouth three times daily for 8 weeks.
Coconut Oil
DrugEnteric coated coconut oil taken by mouth three times daily for 8 weeks
Treatment groups
Trial outcomes
Primary outcomes
O'Leary/Sant questionnaire scores
Participant responses to the O'Leary/Sant questionnaire assessing IC/BPS symptoms will be compared at baseline and after starting treatment with peppermint oil.
Pelvic Pain and Urgency/Frequency questionnaire scores
Participant responses to the Pelvic Pain and Urgency/Frequency questionnaire assessing IC/BPS symptoms will be compared at baseline and after starting treatment with peppermint oil.
Secondary outcomes
Urine pH
Changes in urine pH on urine dipstick from clinically indicated lab collections at the time of office visits during the study period
Incidence of urinary tract infections (UTIs)
Culture proven UTIs during the study period (\>100,000 CFU of a single pathogen)
Additional IC/BPS Treatments received
Number and type of additional IC/BPS each participant undergoes
Sponsors and contacts
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University of Louisville
Lead sponsor
Integrative Therapeutics, Inc.
Collaborator