- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05259800
Peppermint Oil for Urinary Retention
Evaluating the Use of Peppermint Oil for Postpartum Women With Urinary Retention
A randomized controlled study will be conducted, with two arms. Postpartum women experiencing urinary retention will be randomized into one of the two following arms:
- Arm 1: Subjects will be exposed to vapor of peppermint oil
- Arm 2: Subjects will be exposed to vapor of placebo (mineral oil) Outcome variables include resolution of urinary retention, time to spontaneous urination, volume of spontaneous urination, frequency of urinary catheterization, and patient satisfaction.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of the study is to determine if the use of peppermint oil among postpartum women experiencing urinary retention will increase spontaneous urination and decrease the need for catheterization. A randomized controlled study will be conducted, with two arms. Subjects will be randomized into one of the two following arms:
- Arm 1: Subjects will be exposed to vapor of peppermint oil
- Arm 2: Subjects will be exposed to vapor of placebo (mineral oil) Outcome variables include resolution of urinary retention, time to spontaneous urination, volume of spontaneous urination, frequency of urinary catheterization, and patient satisfaction.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45242
- Bethesda North Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
1. 18 years old or older 2. English speaking 3. Admitted to Bethesda North Mom Baby Unit 4. Postpartum 5. Experiencing urinary retention - defined as meeting at least one of the following criteria:
- More than 6 hours after delivery or foley catheter removal without being able to spontaneously void
- Symptomatic urinary retention without being able to spontaneously void
- Change in fundal height or position without being able to spontaneously void 6. Bladder scan showing bladder containing 400mL or more urine
Exclusion Criteria:
- Allergy to peppermint
- Asthma
- Active herpes lesions
- Seizure disorder
- Not able to void in toilet (ex: requiring use of bed pan to void)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Peppermint Oil
Subjects will be exposed to vapor of peppermint oil
|
Subjects will be exposed to vapor of peppermint oil
|
|
Placebo Comparator: Placebo
Subjects will be exposed to vapor of placebo (mineral oil)
|
Subjects will be exposed to vapor of placebo (mineral oil)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percent of Patients With Urinary Retention Resolved
Time Frame: 10 minutes
|
Urinary retention defined as:
Resolution of urinary retention will be achieved if patient spontaneously voids within 10 minutes after exposure to oil |
10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to Spontaneous Urination
Time Frame: 1 hour
|
Minutes until participant spontaneously voids
|
1 hour
|
|
Volume of Spontaneous Urination
Time Frame: 1 hour
|
Volume of urine when participant spontaneously voids
|
1 hour
|
|
Incidence of Urinary Catheterization
Time Frame: 1 hour
|
Whether participant requires urinary catheterization or not
|
1 hour
|
|
Patient Satisfaction
Time Frame: 1 hour
|
Patient rated satisfaction
|
1 hour
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-065
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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