Peppermint Oil for the Treatment of Interstitial Cystitis / Bladder Pain Syndrome

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of Peppermint Oil in a Randomized, Single-Blind, Placebo Controlled Trial in Women With Interstitial Cystitis/Bladder Pain Syndrome

Conditions
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Interstitial Cystitis

Intervention / Treatment
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* Drug: Peppermint oil
* Drug: Coconut Oil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peppermint Oil<br>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). | Drug: Peppermint oil<br>* Enteric coated peppermint oil taken by mouth three times daily for 8 weeks.<br>* Other names: Peptogest Peppermint Oil;|
| Placebo Comparator: Coconut Oil<br>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). | Drug: Coconut Oil<br>* Enteric coated coconut oil taken by mouth three times daily for 8 weeks<br>* Other names: Coconut Oil Pure Extra Virgin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 8 weeks | 
| 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. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine pH | Changes in urine pH on urine dipstick from clinically indicated lab collections at the time of office visits during the study period | 8 weeks | 
| Incidence of urinary tract infections (UTIs) | Culture proven UTIs during the study period (>100,000 CFU of a single pathogen) | 8 weeks | 
| Additional IC/BPS Treatments received | Number and type of additional IC/BPS each participant undergoes | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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interstitial cystitis, bladder pain syndrome, peppermint