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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05259800
Other study ID # 21-065
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date October 5, 2021
Est. completion date March 30, 2026

Study information

Verified date February 2024
Source TriHealth Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 100
Est. completion date March 30, 2026
Est. primary completion date January 30, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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: 1. Allergy to peppermint 2. Asthma 3. Active herpes lesions 4. Seizure disorder 5. Not able to void in toilet (ex: requiring use of bed pan to void)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Peppermint oil vapors
Subjects will be exposed to vapor of peppermint oil
Mineral Oil
Subjects will be exposed to vapor of placebo (mineral oil)

Locations

Country Name City State
United States Bethesda North Hospital Cincinnati Ohio

Sponsors (1)

Lead Sponsor Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
10 minutes
Secondary Time to spontaneous urination Minutes until participant spontaneously voids 1 hour
Secondary Volume of spontaneous urination Volume of urine when participant spontaneously voids 1 hour
Secondary Incidence of urinary catheterization Whether participant requires urinary catheterization or not 1 hour
Secondary Patient satisfaction Patient rated satisfaction 1 hour
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