Essential Oil Vapor for Urinary Retention

(PURE Trial)

Overseen By Robin L Driver, BS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Mount Carmel Health System

Disqualifiers: Peppermint allergy, Asthma, Smell sensitivity, others

Compensation: Varies

Number of Visits: 2

Duration: Within 6 hours postpartum

390 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing if peppermint oil can help new mothers urinate more easily and reduce the need for catheters by relaxing muscles and stimulating the bladder.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

Is essential oil vapor safe for humans?

Some components of essential oils, like pulegone found in peppermint oil, have shown potential harmful effects in animal studies, such as bladder issues in rats. However, menthol, another component of peppermint oil, is widely used in consumer products and is generally considered safe for humans at typical exposure levels. ^{1 2 3 4 5}

How does peppermint oil vapor treatment for urinary retention differ from other treatments?

Peppermint oil vapor is unique because it is administered through inhalation, which is different from traditional oral or topical treatments. This method may offer a novel way to address urinary retention by potentially relaxing the bladder muscles, similar to how other essential oils have been used for different urinary symptoms. ^{1 2 6 7 8}

Who Is on the Research Team?

Robin L Driver, BS

Principal Investigator

Mount Carmel Health System

Are You a Good Fit for This Trial?

This trial is for postpartum women who can't naturally urinate within 6 hours after vaginal or cesarean delivery at Mount Carmel hospitals and understand English. It's not for those sensitive to smells, allergic to peppermint oil, have asthma, or can't walk/use a toilet.

Inclusion Criteria

You can't empty your bladder without help within 6 hours of giving birth.

Criterion: Women who have recently given birth at specific hospitals.

Able to read and understand English

Exclusion Criteria

You are sensitive to strong smells.

You are allergic to peppermint oil.

You have asthma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are exposed to either peppermint oil vapor or mineral oil vapor to promote voiding and reduce urinary catheterization

Within 6 hours postpartum

1 visit (in-person)

Follow-up

Participants are monitored for resolution of postpartum urinary retention and patient satisfaction

Within 6 hours postpartum

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Mineral Oil Vapor
• Peppermint Oil Vapor

Trial Overview The PURE study tests if inhaling peppermint oil vapor helps postpartum women pee to avoid the need for catheterization. It compares this natural approach with breathing in mineral oil vapor as a control.

How Is the Trial Designed?

Group I: Peppermint Oil Vapor Active Control 1 Intervention

Exposure of the perineum to the vapor of the active comparator, 2 ml peppermint oil. The perineum will NOT come into contact with the oil directly.

Group II: Mineral Oil Vapor Placebo Group 1 Intervention

Exposure of the perineum to the vapor of the placebo comparator, 2 ml mineral oil. The perineum will NOT come into contact with the oil directly.

Who Is Running the Clinical Trial?

Mount Carmel Health System

Lead Sponsor

Trials

15

Recruited

10,100+

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Mode of action of pulegone on the urinary bladder of F344 rats. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Randomized controlled trial for Salvia sclarea or Lavandula angustifolia: differential effects on blood pressure in female patients with urinary incontinence undergoing urodynamic examination. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Determination of Menthol in Plasma and Urine by Gas Chromatography/Mass Spectrometry (GC/MS). [2021]

4. England pubmed.ncbi.nlm.nih.gov

Delayed release peppermint oil capsules (Colpermin) for the spastic colon syndrome: a pharmacokinetic study. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Terpene compound drug as medical expulsive therapy for ureterolithiasis: a meta-analysis. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

The Impact of Selected Essential Oils Applied to Non-Woven Viscose on Bacteria That Cause Lower Urinary Tract Infections-Preliminary Studies. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Lavandula angustifolia Mill. Oil and Its Active Constituent Linalyl Acetate Alleviate Pain and Urinary Residual Sense after Colorectal Cancer Surgery: A Randomised Controlled Trial. [2020]

8. Australia pubmed.ncbi.nlm.nih.gov

Vanilla scent reduces frequency of urination in urethane-anesthetized rats. [2021]