Peppermint Oil for Urinary Retention

Sponsor
TriHealth Inc. (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05259800
Collaborator
(none)
100
1
2
29.8
3.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Peppermint oil vapors
  • Other: Mineral Oil
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluating the Use of Peppermint Oil for Postpartum Women With Urinary Retention
Actual Study Start Date :
Oct 5, 2021
Anticipated Primary Completion Date :
Dec 30, 2023
Anticipated Study Completion Date :
Mar 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Peppermint Oil

Subjects will be exposed to vapor of peppermint oil

Other: Peppermint oil vapors
Subjects will be exposed to vapor of peppermint oil

Placebo Comparator: Placebo

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

Other: Mineral Oil
Subjects will be exposed to vapor of placebo (mineral oil)

Outcome Measures

Primary Outcome Measures

  1. Whether patient had resolution of urinary retention [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 Outcome Measures

  1. Time to spontaneous urination [1 hour]

    Minutes until participant spontaneously voids

  2. Volume of spontaneous urination [1 hour]

    Volume of urine when participant spontaneously voids

  3. Incidence of urinary catheterization [1 hour]

    Whether participant requires urinary catheterization or not

  4. Patient satisfaction [1 hour]

    Patient rated satisfaction

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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:
  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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bethesda North Hospital Cincinnati Ohio United States 45242

Sponsors and Collaborators

  • TriHealth Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
TriHealth Inc.
ClinicalTrials.gov Identifier:
NCT05259800
Other Study ID Numbers:
  • 21-065
First Posted:
Mar 2, 2022
Last Update Posted:
May 5, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by TriHealth Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 5, 2022