Postpartum Urinary Retention With Essential Oils (PURE) (PURE)

Postpartum Urinary Retention With Essential Oils (PURE): A Randomized Control Trial of Essential Oil Vapor to Reduce Urinary Catheterization in Postpartum Women

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Urinary Retention
• Intervention / Treatment: Other: Peppermint Oil Vapor; Other: Mineral Oil Vapor

• Study Type: Interventional
• Enrollment (Estimated): 390
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Robin L Driver, BS; Phone Number: 614.620-6590; Email: rdriver@mchs.com
• Study Contact Backup: Name: Theresa Colbert, MSN; Phone Number: 614.309-9325; Email: tcolbert@mchs.com

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43232
      • Mount Carmel Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• postpartum patients at Mount Carmel East, Mount Carmel West, and Mount Carmel St. Ann's Hospital
• 18 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Peppermint Oil Vapor; 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; 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.
Placebo Comparator: Mineral Oil Vapor; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resolution of Postpartum Urinary Retention	Spontaneous bladder voiding of at least 150 milliliters	within 10 minutes after administering study intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to resolution of urinary retention	Time to resolution of postpartum urinary retention, defined as time from either 6 hours after vaginal delivery or within 6 hours after straight catheter in recovery or 6 hours after catheter removal for cesarean delivery to resolution of postpartum urinary retention.	Within 6 hours of postpartum urinary retention
Volume of urine voided	Volume of urine voided within 10 minutes after study intervention administration, expressed in milliliters	Within 6 hours of postpartum urinary retention
Patient Satisfaction Level	defined as patient rating of "agree" or "disagree" or "don't know" to the question, "I would recommend this treatment to other patients who cannot empty their bladder after delivering a baby."	Within one hour of study intervention administration

Collaborators and Investigators

• Sponsor: Mount Carmel Health System
• Investigators: Principal Investigator: Robin L Driver, BS, Mount Carmel Health System

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: October 18, 2017
• First Submitted That Met QC Criteria: October 23, 2017
• First Posted (Actual): October 24, 2017

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: August 16, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Retention; Physiological Effects of Drugs; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Emollients; Peppermint oil; Mineral Oil
• Other Study ID Numbers: 170316-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No