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

Phase 1

Recruiting

• Conditions: Interstitial Cystitis
• Interventions: Drug: Peppermint oil; Drug: Coconut Oil

• Registration Number: NCT04845217
• Lead Sponsor: University of Louisville

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.

Study Timeline

• Study First Submitted: 2021-03-29
• Study First Submitted QC: 2021-04-12
• Study First Posted: 2021-04-14
• Study Start: 2021-09-15
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-19
• Last Update Posted: 2022-08-22
• Primary Completion: 2023-06
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peppermint Oil	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).
Coconut Oil	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).

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Springs Medical Center; 🇺🇸 Louisville, Kentucky, United States