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

Primary Purpose

Urinary Retention

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peppermint Oil Vapor
Mineral Oil Vapor
Sponsored by
Mount Carmel Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Retention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Mount Carmel Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Peppermint Oil Vapor

Mineral Oil Vapor

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Resolution of Postpartum Urinary Retention
Spontaneous bladder voiding of at least 150 milliliters

Secondary Outcome Measures

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.
Volume of urine voided
Volume of urine voided within 10 minutes after study intervention administration, expressed in milliliters
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."

Full Information

First Posted
October 18, 2017
Last Updated
August 16, 2023
Sponsor
Mount Carmel Health System
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1. Study Identification

Unique Protocol Identification Number
NCT03319498
Brief Title
Postpartum Urinary Retention With Essential Oils (PURE)
Acronym
PURE
Official Title
Postpartum Urinary Retention With Essential Oils (PURE): A Randomized Control Trial of Essential Oil Vapor to Reduce Urinary Catheterization in Postpartum Women
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mount Carmel Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Retention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
390 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Peppermint Oil Vapor
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Mineral Oil Vapor
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Peppermint Oil Vapor
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Mineral Oil Vapor
Intervention Description
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.
Primary Outcome Measure Information:
Title
Resolution of Postpartum Urinary Retention
Description
Spontaneous bladder voiding of at least 150 milliliters
Time Frame
within 10 minutes after administering study intervention
Secondary Outcome Measure Information:
Title
Time to resolution of urinary retention
Description
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.
Time Frame
Within 6 hours of postpartum urinary retention
Title
Volume of urine voided
Description
Volume of urine voided within 10 minutes after study intervention administration, expressed in milliliters
Time Frame
Within 6 hours of postpartum urinary retention
Title
Patient Satisfaction Level
Description
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."
Time Frame
Within one hour of study intervention administration

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Study participants are postpartum women with urinary retention.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robin L Driver, BS
Organizational Affiliation
Mount Carmel Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Carmel Health System
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43232
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Postpartum Urinary Retention With Essential Oils (PURE)

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