Urinary RetentionPURENCT03319498
Postpartum Urinary Retention With Essential Oils (PURE)
A study testing Peppermint Oil Vapor and Mineral Oil Vapor in people with Urinary Retention, run by Mount Carmel Health System at 1 site in United States.
Trial summary
The purpose of this study is to examine the effectiveness of peppermint oil to promote voiding and reduce urinary catheterization among postpartum women. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Retention
- What is being tested?
- Peppermint Oil Vapor and Mineral Oil Vapor
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 16 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postpartum Urinary Retention With Essential Oils (PURE): A Randomized Control Trial of Essential Oil Vapor to Reduce Urinary Catheterization in Postpartum Women
The purpose of this study is to examine the effectiveness of peppermint oil to promote voiding and reduce urinary catheterization among postpartum women.
- Conditions
- Urinary Retention
- Being tested
- Peppermint Oil Vapor, Mineral Oil Vapor
- Medical subject headings
- Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peppermint Oil VaporOther
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.
Mineral Oil VaporOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Peppermint Oil Vapor | Active comparator | 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. Receives: Other: Peppermint Oil Vapor |
| Mineral Oil Vapor | Placebo comparator | 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. Receives: Other: Mineral Oil Vapor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of Postpartum Urinary Retention
Spontaneous bladder voiding of at least 150 milliliters
Measured: within 10 minutes after administering study intervention
Secondary outcomes (3)
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.
Measured: Within 6 hours of postpartum urinary retention
Volume of urine voided
Volume of urine voided within 10 minutes after study intervention administration, expressed in milliliters
Measured: Within 6 hours of postpartum urinary retention
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."
Measured: Within one hour of study intervention administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start1 Jan 2018
- Primary completion16 Feb 2026
- Study completion16 Feb 2026
Why it stopped: Low enrollment, lack of clinical staff support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary RetentionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Carmel Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robin Driver, Mount Carmel Health System
- Investigators
- Robin L Driver, BS, Principal investigator, Mount Carmel Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03319498
- Sponsor's protocol ID
- 170316-1
- Acronym
- PURE
- Status last verified
- Mar 2026
- First submitted
- 18 Oct 2017
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postpartum Urinary Retention With Essential Oils (PURE): A Randomized Control Trial of Essential Oil Vapor to Reduce Urinary Catheterization in Postpartum Women
- ClinicalTrials.gov ID
- NCT03319498
- Acronym / sponsor ID
- PURE / 170316-1
- Conditions
- Urinary Retention
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment, lack of clinical staff support
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Mount Carmel Health SystemUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 16 Feb 2026 (actual)
- Study completion
- 16 Feb 2026 (actual)
- First posted
- 24 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the effectiveness of peppermint oil to promote voiding and reduce urinary catheterization among postpartum women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Peppermint Oil Vapor | Active comparator | Other: Peppermint Oil VaporExposure 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. |
| Mineral Oil Vapor | Placebo comparator | Other: Mineral Oil VaporExposure 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peppermint Oil Vapor2ml 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. | Other | Peppermint Oil Vapor |
| Mineral Oil Vapor2ml 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. | Other | Mineral Oil Vapor |
Primary outcome
Resolution of Postpartum Urinary Retention
Time frame: within 10 minutes after administering study intervention
Spontaneous bladder voiding of at least 150 milliliters
3 secondary outcomes
Time to resolution of urinary retention
Time frame: Within 6 hours of postpartum urinary retention
Volume of urine voided
Time frame: Within 6 hours of postpartum urinary retention
Patient Satisfaction Level
Time frame: Within one hour of study intervention administration
Results and safety
The study was stopped early (reason given: Low enrollment, lack of clinical staff support). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robin L Driver, BS principal investigator
Mount Carmel Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peppermint Oil Vapor and Mineral Oil Vapor in people with Urinary Retention, run by Mount Carmel Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low enrollment, lack of clinical staff support). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of Postpartum Urinary Retention (time frame: within 10 minutes after administering study intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.