Back to resultsPeppermint Oil for Urinary Retention
Primary Purpose
Urinary Retention
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peppermint oil vapors
Mineral Oil
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Retention focused on measuring peppermint oil, postpartum
Eligibility Criteria
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)
Sites / Locations
- Bethesda North Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Peppermint Oil
Placebo
Arm Description
Subjects will be exposed to vapor of peppermint oil
Subjects will be exposed to vapor of placebo (mineral oil)
Outcomes
Primary Outcome Measures
Percent of patients with urinary retention resolved
Urinary retention defined as:
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 More than 6 hours after delivery or foley catheter removal without voiding spontaneously; symptomatic urinary retention without being able to spontaneously void; or change in fundal height or position without being able to spontaneously void
Resolution of urinary retention will be achieved if patient spontaneously voids within 10 minutes after exposure to oil
Secondary Outcome Measures
Time to spontaneous urination
Minutes until participant spontaneously voids
Volume of spontaneous urination
Volume of urine when participant spontaneously voids
Incidence of urinary catheterization
Whether participant requires urinary catheterization or not
Patient satisfaction
Patient rated satisfaction
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05259800
Brief Title
Peppermint Oil for Urinary Retention
Official Title
Evaluating the Use of Peppermint Oil for Postpartum Women With Urinary Retention
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 5, 2021 (Actual)
Primary Completion Date
January 30, 2024 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TriHealth Inc.
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
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Retention
Keywords
peppermint oil, postpartum
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Peppermint Oil
Arm Type
Experimental
Arm Description
Subjects will be exposed to vapor of peppermint oil
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will be exposed to vapor of placebo (mineral oil)
Intervention Type
Other
Intervention Name(s)
Peppermint oil vapors
Intervention Description
Subjects will be exposed to vapor of peppermint oil
Intervention Type
Other
Intervention Name(s)
Mineral Oil
Intervention Description
Subjects will be exposed to vapor of placebo (mineral oil)
Primary Outcome Measure Information:
Title
Percent of patients with urinary retention resolved
Description
Urinary retention defined as:
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 More than 6 hours after delivery or foley catheter removal without voiding spontaneously; symptomatic urinary retention without being able to spontaneously void; or change in fundal height or position without being able to spontaneously void
Resolution of urinary retention will be achieved if patient spontaneously voids within 10 minutes after exposure to oil
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Time to spontaneous urination
Description
Minutes until participant spontaneously voids
Time Frame
1 hour
Title
Volume of spontaneous urination
Description
Volume of urine when participant spontaneously voids
Time Frame
1 hour
Title
Incidence of urinary catheterization
Description
Whether participant requires urinary catheterization or not
Time Frame
1 hour
Title
Patient satisfaction
Description
Patient rated satisfaction
Time Frame
1 hour
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Postpartum women
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Bethesda North Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Peppermint Oil for Urinary Retention
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