NCT05259800

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 5, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
5 months until next milestone

Results Posted

Study results publicly available

August 29, 2025

Completed
Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

3.5 years

First QC Date

February 18, 2022

Results QC Date

August 12, 2025

Last Update Submit

August 28, 2025

Conditions

Urinary Retention

Keywords

peppermint oilpostpartum

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Time to Spontaneous Urination

    1 hour

  • Volume of Spontaneous Urination

    1 hour

  • Incidence of Urinary Catheterization

    1 hour

  • Patient Satisfaction

    1 hour

Study Arms (2)

Peppermint Oil

EXPERIMENTAL

Subjects will be exposed to vapor of peppermint oil

Other: Peppermint oil vapors

Placebo

PLACEBO COMPARATOR

Subjects will be exposed to vapor of placebo (mineral oil)

Other: Mineral Oil

Interventions

Peppermint oil vaporsOTHER

Subjects will be exposed to vapor of peppermint oil

Peppermint Oil
Mineral OilOTHER

Subjects will be exposed to vapor of placebo (mineral oil)

Placebo

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPostpartum women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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

You may not qualify if:

  • Allergy to peppermint
  • Asthma
  • Active herpes lesions
  • Seizure disorder
  • Not able to void in toilet (ex: requiring use of bed pan to void)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bethesda North Hospital

Cincinnati, Ohio, 45242, United States

Location

MeSH Terms

Conditions

Urinary Retention

Interventions

Mineral Oil

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

PetrolatumHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Nurse Researcher
Organization
TriHealth
Rachel_Baker2@trihealth.com
513-569-6191

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2022

First Posted

March 2, 2022

Study Start

October 5, 2021

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

August 29, 2025

Results First Posted

August 29, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)