Postpartum Urinary Retention With Essential Oils (PURE)

NCT03319498 | Terminated

• 1 other identifier: 170316-1
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the effectiveness of peppermint oil to promote voiding and reduce urinary catheterization among postpartum women.

Conditions

Urinary Retention

Outcome Measures

Primary Outcomes (1)

• Resolution of Postpartum Urinary Retention

  Spontaneous bladder voiding of at least 150 milliliters

  within 10 minutes after administering study intervention

Secondary Outcomes (3)

• Time to resolution of urinary retention

  Within 6 hours of postpartum urinary retention

• Volume of urine voided

  Within 6 hours of postpartum urinary retention

• Patient Satisfaction Level

  Within one hour of study intervention administration

Study Arms (2)

Peppermint Oil Vapor

ACTIVE COMPARATOR

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.

Other: Peppermint Oil Vapor

Mineral Oil Vapor

PLACEBO COMPARATOR

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.

Other: Mineral Oil Vapor

Interventions

Peppermint Oil Vapor OTHER

2ml of the oil will be placed in the urine collection "hat" that fits into the bowl of the toilet. Participants will then sit on the toilet in normal fashion, exposing their perineum to the vapor of the oil. The perineum will NOT come into contact with the oil directly - only the vapor from the oil will contact the perineum.

Peppermint Oil Vapor

Mineral Oil Vapor OTHER

2ml of the mineral oil will be placed in the urine collection "hat" that fits into the bowl of the toilet. Participants will then sit on the toilet in normal fashion, exposing their perineum to the vapor of the oil. The perineum will NOT come into contact with the oil directly - only the vapor from the oil will contact the perineum.

Mineral Oil Vapor

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Study participants are postpartum women with urinary retention.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• postpartum patients at Mount Carmel East, Mount Carmel West, and Mount Carmel St. Ann's Hospital
• years or older
• able to read and understand English
• unable to spontaneously void within 6 hours after vaginal delivery or within 6 hours after straight catheter or within 6 hours after catheter removal for cesarean delivery.

You may not qualify if:

• patients who have an allergy to peppermint oil
• patients who have asthma
• patients who report sensitivity to smells
• patients who have a clinical condition which precludes walking/use of standard toilet

Sponsors & Collaborators

• Mount Carmel Health System: lead

Study Sites (1)

Mount Carmel Health System

Columbus, Ohio, 43232, United States

Location

MeSH Terms

Conditions

Urinary Retention

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Robin L Driver, BS

  Mount Carmel Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: October 18, 2017
• First Posted: October 24, 2017
• Study Start: January 1, 2018
• Primary Completion: February 16, 2026
• Study Completion: February 16, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

US (1)