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Peppermint Oil for Interstitial Cystitis / Bladder Pain Syndrome

This study is investigating if peppermint oil can help women with Interstitial Cystitis / Bladder Pain Syndrome (IC/BPS), a chronic bladder condition causing pain and discomfort. You would take either enteric-coated peppermint oil or enteric-coated coconut oil (as a placebo) by mouth three times a day for 8 weeks. Researchers will measure how well the treatment works by looking at your scores on questionnaires about your symptoms, such as the O'Leary/Sant and Pelvic Pain and Urgency/Frequency questionnaires, after 8 weeks. The study is looking for 100 women between 18 and 65 years old who have been diagnosed with IC/BPS for at least one month. The current recruitment status is unclear.

Study design
This is an interventional study where participants will be randomly assigned to receive either peppermint oil or coconut oil (placebo). The study plans to enroll 100 participants.
What's involved
You would complete screening questionnaires, give written consent, and then take a study medication by mouth three times daily for 8 weeks. You would also complete follow-up surveys and questionnaires over these 8 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your symptoms will be assessed at 8 weeks after starting the study medication.

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NCT04845217

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

Recruiting
PHASE1Ages 18–65InterventionalTreatment
University of Louisville
~100 participants
Updated 2022-08-22 on ClinicalTrials.gov
What's tested:Peppermint oilCoconut Oil

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
O'Leary/Sant questionnaire scores
Measured over 8 weeks
+1 more outcome measured

Conditions

Interstitial Cystitis

Explore related trials

Chronic primary bladder pain syndromeInterstitial Cystitis

Where it's being run

1 sites across 1 states
Kentucky1

Study leadership

  • Sean Francis, MD · PRINCIPAL_INVESTIGATOR · Department Chair

Who to contact

Jenna Warehime, DO
[email protected]
502-588-7660
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Women ages 18-65 years old
Diagnosed with IC/BPS for at least one month prior to study enrollment

Exclusion

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

What this trial measures

  • O'Leary/Sant questionnaire scores8 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 scores8 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.