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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether inhaling peppermint oil vapor can help new mothers urinate more easily after childbirth, potentially reducing catheter use. Participants will inhale either peppermint oil vapor or mineral oil vapor for comparison. The trial targets postpartum women unable to urinate independently within 6 hours after childbirth or catheter removal. Women with a peppermint oil allergy, asthma, or sensitivity to smells should not participate. As an unphased trial, it offers participants the opportunity to contribute to innovative postpartum care solutions.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that peppermint oil is generally safe for use. However, it may irritate the eyes and skin. Inhaling large amounts might also irritate the lungs and stomach. Pulegone, one ingredient, can affect the bladder at high doses, but this is unlikely with the amounts used in most treatments. Overall, peppermint oil is non-flammable and considered safe when used correctly. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about peppermint oil vapor for urinary retention because it offers a novel, non-invasive approach compared to traditional solutions like catheterization or medications. This treatment uses the vapor from peppermint oil, which is believed to stimulate the nerves in the perineum, potentially triggering urination without direct contact with the skin. Unlike current options that can be uncomfortable or carry side effects, peppermint oil vapor might provide a simpler, gentler alternative.

What evidence suggests that peppermint oil vapor might be an effective treatment for urinary retention?

This trial will compare the effects of peppermint oil vapor with mineral oil vapor for urinary retention. Research suggests that peppermint oil, which participants in this trial may receive, might assist new mothers who struggle to urinate after childbirth. Some studies indicate it could facilitate independent urination. However, these studies have not provided strong proof to fully recommend its use in medical settings. The potential benefits likely stem from peppermint oil's ability to reduce inflammation, relax muscles, and protect cells. While promising, further research is needed to confirm its effectiveness. ^{3 5 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.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/00/NCT05259800/Prot_SAP_000.pdf

Evaluating the use of peppermint oil for postpartum women ...

This descriptive study provides preliminary data that peppermint oil could potentially be an effective intervention for urinary retention, but ...

2.

jognn.org

jognn.org/article/S0884-2175(24)00204-1/fulltext

Postpartum Urinary Retention With Essential Oils

Peppermint oil increased spontaneous voiding; however, findings were not statistically significant to support its use in clinical practice. Limitations include ...

3.

pdfs.semanticscholar.org

pdfs.semanticscholar.org/f38f/82a5003eff635a5fbeb926dd33f0e8dbbc60.pdf

Prevention of Postpartum Urinary Retention with ...

Peppermint oil is estimated to be one of the modalities in preventing health problems through antioxidant, anti-inflammatory, and antispasmodic ...

4.

researchgate.net

researchgate.net/publication/376225222_Prevention_of_Postpartum_Urinary_Retention_with_Peppermint_Oil_Vapor

(PDF) Prevention of Postpartum Urinary Retention with ...

Peppermint oil is estimated to be one of the modalities in preventing health problems through antioxidant, anti-inflammatory, and antispasmodic effects. Further ...

5.

withpower.com

withpower.com/trial/phase-urinary-retention-9-2021-73e04

Peppermint Oil for Urinary Retention · Info for Participants

Trial Overview The study is testing if inhaling peppermint oil vapors helps postpartum women urinate more easily compared to inhaling mineral oil (placebo).

6.

fishersci.com

fishersci.com/store/msds?partNumber=S25458&productDescription=PEPPERMINT+OIL+25GM&vendorId=VN00115888&countryCode=US&language=en

Safety Data Sheet

Additional information (precautions):. Avoid inhaling gases, fumes, dust, mist, vapor, and aerosols. Avoid contact with skin, eyes, and clothing ...

7.

semanticscholar.org

semanticscholar.org/paper/0202d4b135aaea5bd4ddae101c9489d48b51dc10

[PDF] Prevention of Postpartum Urinary Retention with ...

This study showed that peppermint oil on PPUR prevention has no significant effect and may require further investigation, and support of screening ...

8.

praannaturals.com

praannaturals.com/downloads/msds/SDS_Organic_Essential_Oil_Peppermint_OEOPEPPERMINTIN546.pdf

Organic Peppermint Essential Oil

Health Hazards: May cause eye and skin irritation. May cause respiratory and digestive tract irritation. Flammability Hazards: Non-flammable.