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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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, Bladder scan showing bladder containing 400mL or more urine
18 years old or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 minutes
Awards & highlights
Study Summary
This trial will study whether exposure to peppermint oil can help relieve urinary retention for postpartum women.
Who is the study for?
This trial is for English-speaking women over 18 who've recently given birth at Bethesda North Mom Baby Unit and are having trouble urinating on their own. They must be able to use the toilet normally, without a bedpan. Women with peppermint allergies, asthma, active herpes lesions, or seizure disorders cannot participate.Check my eligibility
What is being tested?
The study is testing if inhaling peppermint oil vapors helps postpartum women urinate more easily compared to inhaling mineral oil (placebo). Participants will be randomly assigned to one of these two treatments and monitored for how well they can pee without help and their satisfaction levels.See study design
What are the potential side effects?
Peppermint oil may cause minor side effects like a cooling sensation or tingling in the area where it's applied. In rare cases, it could lead to allergic reactions. Mineral oil is generally considered safe but might cause mild irritation when inhaled.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am unable to urinate on my own and have symptoms or tests confirming this.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent of patients with urinary retention resolved
Secondary outcome measures
Incidence of urinary catheterization
Patient satisfaction
Time to spontaneous urination
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Peppermint OilExperimental Treatment1 Intervention
Subjects will be exposed to vapor of peppermint oil
Group II: PlaceboPlacebo Group1 Intervention
Subjects will be exposed to vapor of placebo (mineral oil)
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Who is running the clinical trial?
TriHealth Inc.Lead Sponsor
98 Previous Clinical Trials
53,641 Total Patients Enrolled
3 Trials studying Urinary Retention
507 Patients Enrolled for Urinary Retention
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Recently gave birthYou are allergic to peppermint.I am unable to urinate on my own and have symptoms or tests confirming this.I cannot use the toilet and need a bed pan.I am 18 years old or older.I have a seizure disorder.I have asthma.I currently have active herpes sores.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Peppermint Oil
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What outcomes is the trial seeking to ascertain?
"The primary indicator of success to be observed over a 10-minute period is the resolution of urinary retention. Secondary metrics include spontaneous urination volume, time until such voiding occurs, and the need for catheterization."
Answered by AI
Is this research project seeking out new members?
"The clinical trial database of clinicaltrials.gov confirms that, as of August 31st 2022, the study is not presently seeking participants. The research originally appeared on October 5th 2021 and no longer recruits new candidates; nonetheless there are still 31 separate trials waiting for enrolment at this time."
Answered by AI
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