Postpartum Urinary Retention With Essential Oils (PURE)

Urinary Retention Clinical Trial

— 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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03319498
• Other study ID #: 170316-1
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 1, 2023

Study information

• Verified date: August 2023
• Source: Mount Carmel Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 390
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Urinary Retention

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Mount Carmel Health System	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Mount Carmel Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution of Postpartum Urinary Retention	Spontaneous bladder voiding of at least 150 milliliters	within 10 minutes after administering study intervention
Secondary	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
Secondary	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
Secondary	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