Peppermint Oil for Urinary Retention

NCT05259800 — Not applicable, Terminated, 17 participants, TriHealth Inc.

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

Evaluating the Use of Peppermint Oil for Postpartum Women With Urinary Retention

RegistryNCT05259800
StatusTerminated - Difficulty enrolling patients
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment17 (Actual)
SponsorTriHealth Inc. (Other)
ConditionsUrinary Retention
InterventionsPeppermint oil vapors, Mineral Oil (Other)
Datesstart 2021-10-05, primary completion 2025-04-01, completion 2025-04-01, first posted 2022-03-02, last updated 2025-08-29
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Urinary Retention All trials of Peppermint oil vapors All trials of Mineral Oil

-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.

Expand all sections  ·  Collapse all

+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.

+Arms and interventions

ArmTypeInterventionsDescription
Peppermint OilExperimentalOther: Peppermint oil vaporsSubjects will be exposed to vapor of peppermint oil
PlaceboPlacebo comparatorOther: Mineral OilSubjects will be exposed to vapor of placebo (mineral oil)
  • Peppermint oil vapors (Other): Subjects will be exposed to vapor of peppermint oil
  • Mineral Oil (Other): Subjects will be exposed to vapor of placebo (mineral oil)

+Outcome measures

Primary outcomes

  • Percent of Patients With Urinary Retention Resolved [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

Secondary outcomes

  • Time to Spontaneous Urination [1 hour]: Minutes until participant spontaneously voids
  • Volume of Spontaneous Urination [1 hour]: Volume of urine when participant spontaneously voids
  • Incidence of Urinary Catheterization [1 hour]: Whether participant requires urinary catheterization or not
  • Patient Satisfaction [1 hour]: Patient rated satisfaction

+Eligibility

Sex: Female, ages: 18 Years to any, accepts healthy volunteers

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:

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)

+Posted results

Participant flow

MilestonePeppermint OilPlacebo
Started107
Completed107
Not completed00

Outcome results

  • Percent of Patients With Urinary Retention Resolved (Primary), Count of participants, Participants: Peppermint Oil 3; Placebo 1
  • Time to Spontaneous Urination (Secondary)
  • Volume of Spontaneous Urination (Secondary)
  • Incidence of Urinary Catheterization (Secondary)
  • Patient Satisfaction (Secondary)

Adverse events

Time frame: from enrollment until end of follow-up, up to 2 days

ArmDeathsSerious adverse eventsOther adverse events
Peppermint Oil0/10 (0.0%)0/10 (0.0%)0/10 (0.0%)
Placebo0/7 (0.0%)0/7 (0.0%)0/7 (0.0%)

+Locations (1)

FacilityCityCountryStatus
Bethesda North HospitalCincinnati, OhioUnited States

+Study documents