Peppermint Oil for the Treatment of Interstitial Cystitis / Bladder Pain Syndrome
Purpose
The purpose of this study is to assess the use of peppermint oil as a treatment for Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS).
Condition
- Interstitial Cystitis
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Sex
- Female
- Accepts 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
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- 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.
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
- 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.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Peppermint Oil |
Participants in the intervention (peppermint oil) arm will receive soft gels of enteric-coated peppermint oil (0.2mL=200mg). The enteric coated peppermint oil soft gel utilized in this study is Peptogest Peppermint Oil from Schwabe North America (Nature's Way Brand). |
|
|
Placebo Comparator Coconut Oil |
Participants in the placebo (coconut oil) arm will receive soft gels of enteric coated coconut oil. The enteric coated coconut oil soft gel utilized in this study is Coconut Oil from Schwabe North America (Nature's Way Brand). |
|
Recruiting Locations
Springs Medical Center
Louisville, Kentucky 40205
Louisville, Kentucky 40205
Contact:
Sean Francis, MD
Sean Francis, MD
More Details
- Status
- Recruiting
- Sponsor
- University of Louisville
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.