Postpartum Urinary Retention With Essential Oils (PURE)

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

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

Conditions
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Urinary Retention

Intervention / Treatment
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* Other: Peppermint Oil Vapor
* Other: Mineral Oil Vapor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Peppermint Oil Vapor<br>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<br>* 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.<br>|
| Placebo Comparator: Mineral Oil Vapor<br>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<br>* 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.<br>|

What is the study measuring?
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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 |