Peppermint Oil for the Treatment of Interstitial Cystitis / Bladder Pain Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Peppermint oil, Coconut Oil.
- Who it may be relevant to
- Registry conditions: Interstitial Cystitis. Basic parameters: 18 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy of Peppermint Oil in a Randomized, Single-Blind, Placebo Controlled Trial in Women With 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).
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
Primary outcome measures
- O'Leary/Sant questionnaire scores [Time frame: 8 weeks]
- Pelvic Pain and Urgency/Frequency questionnaire scores [Time frame: 8 weeks]
Secondary outcome measures (3)
- Urine pH [Time frame: 8 weeks]
- Incidence of urinary tract infections (UTIs) [Time frame: 8 weeks]
- Additional IC/BPS Treatments received [Time frame: 8 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Springs Medical Center — Louisville
Identifiers
NCT: NCT04845217 · 21.0286