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

Overview

The purpose of this study is to assess the use of peppermint oil as a treatment for Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS).

Full Title of Study: “Efficacy of Peppermint Oil in a Randomized, Single-Blind, Placebo Controlled Trial in Women With Interstitial Cystitis/Bladder Pain Syndrome”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: June 2023

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

  • Drug: Peppermint oil
    • Enteric coated peppermint oil taken by mouth three times daily for 8 weeks.
  • Drug: Coconut Oil
    • Enteric coated coconut oil taken by mouth three times daily for 8 weeks

Arms, Groups and Cohorts

  • 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).

Clinical Trial Outcome Measures

Primary Measures

  • O’Leary/Sant questionnaire scores
    • Time Frame: 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
    • Time Frame: 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 Measures

  • Urine pH
    • Time Frame: 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)
    • Time Frame: 8 weeks
    • Culture proven UTIs during the study period (>100,000 CFU of a single pathogen)
  • Additional IC/BPS Treatments received
    • Time Frame: 8 weeks
    • Number and type of additional IC/BPS each participant undergoes

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Louisville
  • Collaborator
    • Integrative Therapeutics, Inc.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sean Francis, MD, Professor, MD – University of Louisville
  • Overall Official(s)
    • Sean Francis, MD, Principal Investigator, Department Chair
  • Overall Contact(s)
    • Jenna Warehime, DO, 502-588-7660, pepperminttrial@gmail.com

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