Trial Outcomes & Findings for Peppermint Oil for Urinary Retention (NCT NCT05259800)

NCT ID: NCT05259800

Last Updated: 2025-08-29

Results Overview

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

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

17 participants

Primary outcome timeframe

10 minutes

Results posted on

2025-08-29

Participant Flow

Participant milestones

Participant milestones
Measure
Peppermint Oil
Subjects will be exposed to vapor of peppermint oil Peppermint oil vapors: Subjects will be exposed to vapor of peppermint oil
Placebo
Subjects will be exposed to vapor of placebo (mineral oil) Mineral Oil: Subjects will be exposed to vapor of placebo (mineral oil)
Overall Study
STARTED
10
7
Overall Study
COMPLETED
10
7
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Peppermint Oil
n=10 Participants
Subjects will be exposed to vapor of peppermint oil
Placebo
n=7 Participants
Subjects will be exposed to vapor of placebo (mineral oil)
Total
n=17 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=10 Participants
0 Participants
n=7 Participants
0 Participants
n=17 Participants
Age, Categorical
Between 18 and 65 years
10 Participants
n=10 Participants
7 Participants
n=7 Participants
17 Participants
n=17 Participants
Age, Categorical
>=65 years
0 Participants
n=10 Participants
0 Participants
n=7 Participants
0 Participants
n=17 Participants
Sex: Female, Male
Female
10 Participants
n=10 Participants
7 Participants
n=7 Participants
17 Participants
n=17 Participants
Sex: Female, Male
Male
0 Participants
n=10 Participants
0 Participants
n=7 Participants
0 Participants
n=17 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure
Peppermint Oil
n=10 Participants
Subjects will be exposed to vapor of peppermint oil
Placebo
n=7 Participants
Subjects will be exposed to vapor of placebo (mineral oil)
Percent of Patients With Urinary Retention Resolved
3 Participants
1 Participants

SECONDARY outcome

Timeframe: 1 hour

Minutes until participant spontaneously voids

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 hour

Volume of urine when participant spontaneously voids

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 hour

Whether participant requires urinary catheterization or not

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 hour

Patient rated satisfaction

Outcome measures

Outcome data not reported

Adverse Events

Peppermint Oil

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nurse Researcher

TriHealth

Phone: 513-569-6191

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place