Interstitial Cystitis
Conditions
Keywords
interstitial cystitis, bladder pain syndrome, peppermint
Brief summary
The purpose of this study is to assess the use of peppermint oil as a treatment for Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS).
Detailed description
After being informed about the study and potential risks, all participants will complete validated IC/BPS symptom questionnaires for baseline screening. Once participants meet eligibility requirements and give written informed consent they will be randomized in a 1:1 ratio to peppermint oil (200mg TID) or placebo (also TID). Participants will complete validated IC/BPS questionnaires and follow up surveys over 8 weeks.
Interventions
DRUGPeppermint oil
Enteric coated peppermint oil taken by mouth three times daily for 8 weeks.
DRUGCoconut Oil
Enteric coated coconut oil taken by mouth three times daily for 8 weeks
Sponsors
Integrative Therapeutics, Inc.
University of Louisville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
The peppermint-oil and placebo treatments will be kept in a locked and secured area of the office, in a room not used for patient care. The bottles will be de-identified, with labels detailing the specific instructions for how to take the soft gels and the number in each bottle. Each group will be instructed to take one soft gel three times daily. The peppermint oil and placebo medications will be distributed by the research team. The manufacturer label will be covered up/removed and a study label stating the use of a study medication will be used to maintain patient blinding.
Intervention model description
Participants will be randomized in a 1:1 ratio to the intervention or placebo arm. Allocation concealment will be in place to ensure the individual enrolling the subject into the study has no a priori knowledge of group assignment. Block randomization will occur with randomly mixed block sizes of 4, 6, and 8 using the randomization list generator at www.sealedenvelope.com. Randomization information will be kept confidential and only available to study personnel.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Women ages 18-65 years old * Diagnosed with IC/BPS for at least one month prior to study enrollment
Exclusion criteria
* Culture proven urinary tract infection within 1 month of randomization * Gross hematuria * Currently pregnant or breastfeeding * Unable to speak and read English * History of allergic reaction to peppermint, coconut or enteric coating * History of malabsorption syndrome * History of gastroparesis * History of gastric bypass surgery * History of gastrointestinal, genitourinary or pelvic cancer in the last 5 years * History of insulin dependent diabetes * History of active urinary stone disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| O'Leary/Sant questionnaire scores | 8 weeks | 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 | 8 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Urine pH | 8 weeks | 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) | 8 weeks | Culture proven UTIs during the study period (\>100,000 CFU of a single pathogen) |
| Additional IC/BPS Treatments received | 8 weeks | Number and type of additional IC/BPS each participant undergoes |
Countries
United States
Contacts
Primary ContactJenna Warehime, DO
Outcome results
None listed