Urinary RetentionNCT05259800
Peppermint Oil for Urinary Retention
A study testing Peppermint oil vapors and Mineral Oil in people with Urinary Retention, run by TriHealth Inc. at 1 site in United States.
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… 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 vapors and Mineral Oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2021to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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
Who cannot join
- Allergy to peppermint
- Asthma
- Active herpes lesions
- Seizure disorder
- Not able to void in toilet (ex: requiring use of bed pan to void)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Use of Peppermint Oil for Postpartum Women With Urinary Retention
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.
- Conditions
- Urinary Retention
- Being tested
- Peppermint oil vapors, Mineral Oil
- Keywords
- peppermint oil, postpartum
- 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 vaporsOther
Subjects will be exposed to vapor of peppermint oil
Mineral OilOther
Subjects will be exposed to vapor of placebo (mineral oil)
| Study group | Role | What they receive |
|---|---|---|
| Peppermint Oil | Experimental | Subjects will be exposed to vapor of peppermint oil Receives: Other: Peppermint oil vapors |
| Placebo | Placebo comparator | Subjects will be exposed to vapor of placebo (mineral oil) Receives: Other: Mineral Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 minutes
Secondary outcomes (4)
Time to Spontaneous Urination
Minutes until participant spontaneously voids
Measured: 1 hour
Volume of Spontaneous Urination
Volume of urine when participant spontaneously voids
Measured: 1 hour
Incidence of Urinary Catheterization
Whether participant requires urinary catheterization or not
Measured: 1 hour
Patient Satisfaction
Patient rated satisfaction
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start5 Oct 2021
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Why it stopped: Difficulty enrolling patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05259800
- Sponsor's protocol ID
- 21-065
- Status last verified
- Aug 2025
- First submitted
- 18 Feb 2022
- Last updated
- 29 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Use of Peppermint Oil for Postpartum Women With Urinary Retention
- ClinicalTrials.gov ID
- NCT05259800
- Acronym / sponsor ID
- 21-065
- Conditions
- Urinary Retention
- Keywords
- peppermint oil, postpartum
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty enrolling patients
- Enrolment
- 17 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 2 Mar 2022 (actual)
- Results
- Posted 29 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peppermint Oil | Experimental | Other: Peppermint oil vaporsSubjects will be exposed to vapor of peppermint oil |
| Placebo | Placebo comparator | Other: Mineral OilSubjects will be exposed to vapor of placebo (mineral oil) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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:
Key exclusion criteria (5 listed)
- Allergy to peppermint
- Asthma
- Active herpes lesions
- Seizure disorder
- Not able to void in toilet (ex: requiring use of bed pan to void)
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 vaporsSubjects will be exposed to vapor of peppermint oil | Other | Peppermint Oil |
| Mineral OilSubjects will be exposed to vapor of placebo (mineral oil) | Other | Placebo |
Primary outcome
Percent of Patients With Urinary Retention Resolved
Time frame: 10 minutes
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
4 secondary outcomes
Time to Spontaneous Urination
Time frame: 1 hour
Volume of Spontaneous Urination
Time frame: 1 hour
Incidence of Urinary Catheterization
Time frame: 1 hour
Patient Satisfaction
Time frame: 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 vapors and Mineral Oil in people with Urinary Retention, run by TriHealth Inc. 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 5 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 29 Aug 2025. 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?
Yes. Results are posted in the registry (first posted 29 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent of Patients With Urinary Retention Resolved (time frame: 10 minutes). 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 29 Aug 2025; AzTrials last refreshed its copy on 27 Oct 2026.