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TerminatedNCT05259800Updated Aug 29, 2025Results posted

Peppermint Oil for Urinary Retention

An interventional study of Peppermint oil vapors and Mineral Oil in Urinary Retention, sponsored by TriHealth Inc.. Terminated at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-29.

Sponsored by TriHealth Inc. · Not applicable, Interventional, and Treatment

Why this study was terminated
Difficulty enrolling patients

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Oct 2021, registered Feb 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
17
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.
Read the 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.
02

Conditions studied

  • Urinary Retention

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Keywords

  • peppermint oil
  • postpartum
03

In context

Urinary Retention

235 studies on the registry are indexed under Urinary Retention; 39 are open to participants now.

This study's enrollment of 17 is below the median of 95 across 185 interventional studies indexed under Urinary Retention.

Browse Urinary Retention studies →

Lead sponsor

TriHealth Inc. is the lead sponsor of 99 studies on the registry; 9 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    Peppermint Oil

    Subjects will be exposed to vapor of peppermint oil

    Other: Peppermint oil vapors

  • Placebo comparator
    Placebo

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

    Other: Mineral Oil

Interventions

  • OtherPeppermint oil vapors

    Subjects will be exposed to vapor of peppermint oil

  • OtherMineral Oil

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

06

What researchers measure

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

    Time frame: 10 minutes

Secondary outcomes

  1. Time to Spontaneous Urination

    Minutes until participant spontaneously voids

    Time frame: 1 hour

  2. Volume of Spontaneous Urination

    Volume of urine when participant spontaneously voids

    Time frame: 1 hour

  3. Incidence of Urinary Catheterization

    Whether participant requires urinary catheterization or not

    Time frame: 1 hour

  4. Patient Satisfaction

    Patient rated satisfaction

    Time frame: 1 hour

07

Results

Posted Aug 29, 2025

Participant flow

Participant flow — Overall Study
MilestonePeppermint OilPlacebo
Started107
Completed107
Not completed00

Outcome measures

PrimaryPercent 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

Time frame:
10 minutes
Reported as:
Count of participants · Participants
Percent of Patients With Urinary Retention Resolved
ParticipantsPeppermint OilPlacebo
Percent of Patients With Urinary Retention Resolved31
SecondaryTime to Spontaneous Urination

Minutes until participant spontaneously voids

Time frame:
1 hour

Results for this outcome have not been posted.

SecondaryVolume of Spontaneous Urination

Volume of urine when participant spontaneously voids

Time frame:
1 hour

Results for this outcome have not been posted.

SecondaryIncidence of Urinary Catheterization

Whether participant requires urinary catheterization or not

Time frame:
1 hour

Results for this outcome have not been posted.

SecondaryPatient Satisfaction

Patient rated satisfaction

Time frame:
1 hour

Results for this outcome have not been posted.

Adverse events

Collected over from enrollment until end of follow-up, up to 2 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Peppermint Oil0/10 (0%)0/10 (0%)0/10 (0%)
Placebo0/7 (0%)0/7 (0%)0/7 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Peppermint OilPlaceboTotal
<=18 years000
Between 18 and 65 years10717
>=65 years000
Sex: Female, Male
Sex: Female, Male(Participants)Peppermint OilPlaceboTotal
Female10717
Male000
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Peppermint OilPlaceboTotal
Count of participants——0
08

Study locations

1 site
  • Bethesda North Hospital
    Cincinnati, Ohio 45242, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Aug 12, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05259800
Lead sponsor
TriHealth Inc.
Responsible party
Sponsor
First posted
Mar 2, 2022
Start date
Oct 5, 2021
Primary completion
Apr 1, 2025
Completion
Apr 1, 2025
Results posted
Aug 29, 2025
Last update
Aug 29, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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