Urinary Retention
Conditions
Keywords
peppermint oil, postpartum
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.
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.
Interventions
OTHERPeppermint oil vapors
Subjects will be exposed to vapor of peppermint oil
OTHERMineral Oil
Subjects will be exposed to vapor of placebo (mineral oil)
Sponsors
TriHealth Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Peppermint Oil Subjects will be exposed to vapor of peppermint oil | 10 |
| Placebo Subjects will be exposed to vapor of placebo (mineral oil) | 7 |
| Total | 17 |
Baseline characteristics
| Characteristic | Peppermint Oil | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 7 Participants | 17 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 10 Participants | 7 Participants | 17 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 7 |
| other Total, other adverse events | 0 / 10 | 0 / 7 |
| serious Total, serious adverse events | 0 / 10 | 0 / 7 |
Outcome results
Primary
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
Time frame: 10 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Peppermint Oil | Percent of Patients With Urinary Retention Resolved | 3 Participants |
| Placebo | Percent of Patients With Urinary Retention Resolved | 1 Participants |
Secondary
Incidence of Urinary Catheterization
Whether participant requires urinary catheterization or not
Time frame: 1 hour
Secondary
Patient Satisfaction
Patient rated satisfaction
Time frame: 1 hour
Secondary
Time to Spontaneous Urination
Minutes until participant spontaneously voids
Time frame: 1 hour
Secondary
Volume of Spontaneous Urination
Volume of urine when participant spontaneously voids
Time frame: 1 hour