Urinary Retention Clinical Trial
Official title:
Evaluating the Use of Peppermint Oil for Postpartum Women With Urinary Retention
Verified date | February 2024 |
Source | TriHealth Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 100 |
Est. completion date | March 30, 2026 |
Est. primary completion date | January 30, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Bethesda North Hospital | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
TriHealth Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 |
10 minutes | |
Secondary | Time to spontaneous urination | Minutes until participant spontaneously voids | 1 hour | |
Secondary | Volume of spontaneous urination | Volume of urine when participant spontaneously voids | 1 hour | |
Secondary | Incidence of urinary catheterization | Whether participant requires urinary catheterization or not | 1 hour | |
Secondary | Patient satisfaction | Patient rated satisfaction | 1 hour |
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