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NCT Number: NCT04845217

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

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

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Key information

Conditions

Interstitial Cystitis Cystitis Cystitis, Interstitial Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Springs Medical Center

Louisville, Kentucky, 40205, United States

Location status: Recruiting

Location contact

Sean Francis, MD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peppermint oil

Drug

Enteric coated peppermint oil taken by mouth three times daily for 8 weeks.

Other names: Peptogest Peppermint Oil

Coconut Oil

Drug

Enteric coated coconut oil taken by mouth three times daily for 8 weeks

Other names: Coconut Oil Pure Extra Virgin

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. 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

  2. Incidence of urinary tract infections (UTIs)

    Time frame: 8 weeks

    Culture proven UTIs during the study period (>100,000 CFU of a single pathogen)

  3. Additional IC/BPS Treatments received

    Time frame: 8 weeks

    Number and type of additional IC/BPS each participant undergoes

Study contacts

Contact information is provided by the study sponsor or research team.

Jenna Warehime, DO

CONTACT

[email protected]

502-588-7660

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Collaborators

  • Integrative Therapeutics, Inc.

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 14, 2021
Registry last updated
Aug 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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