What side effects are associated with this type of intervention?

Common treatments for urinary retention, particularly those involving herbal or aromatic properties like peppermint oil vapor, generally have mild side effects. For example, Pygeum africanum extract, used for BPH-related urinary disorders, has been associated with gastrointestinal side effects in a small number of patients. Overall, these treatments are well-tolerated, with serious adverse effects being rare. Patients should always consult with their healthcare provider to discuss potential side effects and ensure the chosen treatment is appropriate for their specific condition.

What prior FDA approvals exist?

FDA-approved treatments for urinary retention typically include medications that relax the muscles of the urinary tract, such as alpha-1-adrenergic antagonists (e.g., tamsulosin, alfuzosin) and antimuscarinic agents (e.g., tolterodine, solifenacin). These drugs help alleviate symptoms by reducing muscle tension and improving urine flow. While there is no specific mention of FDA-approved treatments using aromatic properties like peppermint oil vapor, the concept of muscle relaxation is a common therapeutic approach in managing urinary retention.

What other types of research exist?

Promising novel alternatives to peppermint oil vapor for urinary retention include: 1) Transurethral vaporization using a 1470 nm laser, which has shown significant improvement in urinary flow and symptom scores in patients with benign prostatic hyperplasia (BPH). 2) Convective water vapor thermal therapy (Rezūm® System), which has demonstrated efficacy in reducing lower urinary tract symptoms associated with BPH. Both treatments are minimally invasive and have shown positive outcomes in clinical studies.

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Peppermint Oil for Urinary Retention

N/A

Waitlist Available

Research Sponsored by TriHealth Inc.

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

Must not have

Not able to void in toilet (ex: requiring use of bed pan to void)

Seizure disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 minutes

Summary

This trial is testing whether the smell of peppermint oil can help new mothers who are having trouble urinating after childbirth. Researchers hope to see if peppermint oil can help these women urinate on their own and reduce the need for catheters. Peppermint oil has been studied for its effects on nausea, vomiting, and anxiety in various populations, including pregnant women and postoperative patients.

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.

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.

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 below

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I am unable to urinate on my own and have symptoms or tests confirming this.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot use the toilet and need a bed pan.

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I have a seizure disorder.

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I have asthma.

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I currently have active herpes sores.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percent of patients with urinary retention resolved

Secondary study objectives

Incidence of urinary catheterization

Patient satisfaction

Time to spontaneous urination

+1 more

Trial 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)

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for urinary retention often focus on relaxing the muscles of the urinary tract to facilitate urination. For example, peppermint oil vapor is being studied for its aromatic properties, which may help relax the urinary tract muscles, thereby easing the passage of urine. Similarly, muscle relaxants and behavioral interventions like pelvic floor exercises aim to reduce muscle tension and improve bladder function. These mechanisms are crucial for urinary retention patients as they help alleviate the discomfort and potential complications associated with the inability to empty the bladder effectively.

Efficacy of Daily Intake of Dried Cranberry 500 mg in Women with Overactive Bladder: A Randomized, Double-Blind, Placebo Controlled Study.Phytotherapy in the treatment of benign prostatic hyperplasia.