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TerminatedNCT03319498PUREUpdated Mar 5, 2026

Postpartum Urinary Retention With Essential Oils (PURE)

An interventional study of Peppermint Oil Vapor and Mineral Oil Vapor in Urinary Retention, sponsored by Mount Carmel Health System. Terminated at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-05.

Sponsored by Mount Carmel Health System · Not applicable, Interventional, and Treatment

Why this study was terminated
Low enrollment, lack of clinical staff support
Phase
Not applicable
Study type
Interventional
Enrollment
77
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 98 studies in Urinary Retention with a site in United States — 13 open to participants now, 18 under way, 1 of them phase 3. Urinary Retention · United States.

Enrollment
45th of 81
77 · median 88
Started
2018
with 7 others
No phase
53 of 98
6 open now
Registered
43rd of 98
by date

Among the 98 studies in Urinary Retention with a site in United States, this one is the 45th largest by enrollment of the 81 interventional ones, is one of 8 that started in 2018, is one of 53 with no phase, and was the 43rd registered.

By phase

98 studies; the count open now beside each. This study's row is marked.

No phasethis study53 · 6 open
Observational17 · 2 open
Phase 411 · 1 open
Phase 38 · 1 open
Phase 13 · 1 open
Phase 23 · 1 open
Phase 1/22 · 1 open
Phase 2/31 · 0 open

By the year they started

First in 2001; this study’s year is marked. 8 started in 2018.

Size and results

Median enrollment 88 across the 81 interventional studies, 90 across the 17 observational. Of the 69 that completed or were terminated, 35 (51%) have results posted.

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02

Study summary

The purpose of this study is to examine the effectiveness of peppermint oil to promote voiding and reduce urinary catheterization among postpartum women.

03

Conditions studied

  • Urinary Retention

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04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • postpartum patients at Mount Carmel East, Mount Carmel West, and Mount Carmel St. Ann's Hospital
  • 18 years or older
  • able to read and understand English
  • unable to spontaneously void within 6 hours after vaginal delivery or within 6 hours after straight catheter or within 6 hours after catheter removal for cesarean delivery.

Exclusion criteria

Exclusion Criteria:

  • patients who have an allergy to peppermint oil
  • patients who have asthma
  • patients who report sensitivity to smells
  • patients who have a clinical condition which precludes walking/use of standard toilet
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
77 participants (actual)

Study arms

  • Active comparator
    Peppermint Oil Vapor

    Exposure of the perineum to the vapor of the active comparator, 2 ml peppermint oil. The perineum will NOT come into contact with the oil directly.

    Other: Peppermint Oil Vapor

  • Placebo comparator
    Mineral Oil Vapor

    Exposure of the perineum to the vapor of the placebo comparator, 2 ml mineral oil. The perineum will NOT come into contact with the oil directly.

    Other: Mineral Oil Vapor

Interventions

  • OtherPeppermint Oil Vapor

    2ml of the oil will be placed in the urine collection "hat" that fits into the bowl of the toilet. Participants will then sit on the toilet in normal fashion, exposing their perineum to the vapor of the oil. The perineum will NOT come into contact with the oil directly - only the vapor from the oil will contact the perineum.

  • OtherMineral Oil Vapor

    2ml of the mineral oil will be placed in the urine collection "hat" that fits into the bowl of the toilet. Participants will then sit on the toilet in normal fashion, exposing their perineum to the vapor of the oil. The perineum will NOT come into contact with the oil directly - only the vapor from the oil will contact the perineum.

06

What researchers measure

Primary outcomes

  1. Resolution of Postpartum Urinary Retention

    Spontaneous bladder voiding of at least 150 milliliters

    Time frame: within 10 minutes after administering study intervention

Secondary outcomes

  1. Time to resolution of urinary retention

    Time to resolution of postpartum urinary retention, defined as time from either 6 hours after vaginal delivery or within 6 hours after straight catheter in recovery or 6 hours after catheter removal for cesarean delivery to resolution of postpartum urinary retention.

    Time frame: Within 6 hours of postpartum urinary retention

  2. Volume of urine voided

    Volume of urine voided within 10 minutes after study intervention administration, expressed in milliliters

    Time frame: Within 6 hours of postpartum urinary retention

  3. Patient Satisfaction Level

    defined as patient rating of "agree" or "disagree" or "don't know" to the question, "I would recommend this treatment to other patients who cannot empty their bladder after delivering a baby."

    Time frame: Within one hour of study intervention administration

07

Study locations

1 site
  • Mount Carmel Health System
    Columbus, Ohio 43232, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2018 to primary completion in Feb 2026, 97 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 18, 2017
First posted
Oct 24, 2017
StartActual
Jan 1, 2018
Primary completionActual
Feb 16, 2026
CompletionActual
Feb 16, 2026
Last update
Mar 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03319498
Lead sponsor
Mount Carmel Health System
Responsible party
Robin Driver (Principal Investigator, Mount Carmel Health System) — Principal investigator
First posted
Oct 24, 2017
Start date
Jan 1, 2018
Primary completion
Feb 16, 2026
Completion
Feb 16, 2026
Last update
Mar 5, 2026

Study contacts

Robin L Driver, BS
principal investigator · Mount Carmel Health System

Oversight

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

Not currently enrolling

This study is terminated, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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