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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorUniversity of Louisville

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Women ages 18-65 years old

Diagnosed with IC/BPS for at least one month prior to study enrollment

Disqualifiers

Culture proven urinary tract infection within 1 month of randomization

Gross hematuria

Currently pregnant or breastfeeding

Unable to speak and read English

Trial design

Design model

Parallel

Treatments tested in this trial

  • Peppermint oil

    Drug

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

  • Coconut Oil

    Drug

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Peppermint OilExperimental treatment 1 intervention
Group B: Coconut OilPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

O'Leary/Sant questionnaire scores

Participant responses to the O'Leary/Sant questionnaire assessing IC/BPS symptoms will be compared at baseline and after starting treatment with peppermint oil.

Time frame
8 weeks
2

Pelvic Pain and Urgency/Frequency questionnaire scores

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.

Time frame
8 weeks

Secondary outcomes

1

Urine pH

Changes in urine pH on urine dipstick from clinically indicated lab collections at the time of office visits during the study period

Time frame
8 weeks
2

Incidence of urinary tract infections (UTIs)

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

Time frame
8 weeks
3

Additional IC/BPS Treatments received

Number and type of additional IC/BPS each participant undergoes

Time frame
8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Louisville

Lead sponsor

Integrative Therapeutics, Inc.

Collaborator