- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03272204
Pubic Hair and the Urinary and Vaginal Microbiome
June 3, 2020 updated by: Margaret Mueller
Effects of Pubic Hair Grooming on Urinary and Vaginal Microbiome
This research study seeks to find if there is a connection between the presence of pubic hair and the type of bacteria that live in the vagina and bladder.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Urinary tract infections (UTIs) are the most common bacterial infections.
In 2007, in the United States alone, there were an estimated 10.5 million office visits for UTI symptoms (constituting 0.9% of all ambulatory visits) and 2-3 million emergency department visits.
UTIs are significantly more common in women and are a leading cause of urogynecology referrals.
In women, the vagina plays a key role in the pathogenesis of UTIs.
The initial step in the pathogenesis of UTI is colonization of the vaginal opening and peri-urethra with uropathogens from the intestinal microbiota, followed by ascension of uropathogens via the urethra to the bladder and sometimes the kidneys to cause infection.
Thus, understanding factors that affect the microbiota of the vagina is key to understanding the pathogenesis of UTI.
Likewise, since Wolfe et al published the first evidence of a urinary microbiome in 2012, there has been growing interest in whether the content of this microbiome could correlate with symptoms of the lower urinary tract.
The urinary microbiome has been shown to correlate with symptoms of urgency incontinence but to date, there is no data on whether the composition of the urinary microbiome is associated with any change in risk for UTIs.
If the urinary microbiome could play a role in the acquisition of clinical infection, then the factors that affect the microbiome of the bladder would be important in preventing UTIs.
One plausible and modifiable factor that may change the vaginal and urinary microbiome is the presence of pubic hair.
Hair in other parts of the body (nose, ears, eyebrows) traps and stops the passage of pathogens into our mucous membranes.
Additionally, the sebum produced by hair follicles is bacteriostatic.
However, some form of pubic hair grooming is performed by the majority of pre-menopausal women (83%) and 62% of women between age 18-40 report having removed ALL of their pubic hair at one point in life.
This is predominantly done by using non-electric razors (61%) but other women use lasers, waxing and depilatory creams.
Fifty-nine percent of women who perform pubic hair removal report their primary reason is to improve hygiene.
However, there is no data that this practice changes hygiene, with the exception of preventing pubic hair lice.
On the contrary, pubic hair removal has been associated with skin injury leading to inoculation of bacteria and viruses.
In a recent cross-sectional study of pubic hair and sexually transmitted infections, researchers found that frequent pubic hair grooming was correlated with a higher risk for sexually transmitted infections (STIs).
This preliminary work raises the question of whether the presence of pubic hair affects the vaginal or urinary microbiome, thereby changing a woman's risk of infection in either organ.
Furthermore, specific pelvic floor disorders (PFDs) including painful bladder syndrome and urgency urinary incontinence have been associated with specific microbiome profiles.
Therefore, by falsely attempting to maintain pelvic health through grooming practices, women might inadvertently be exposing themselves to PFDs mediated by changes in their urinary or vaginal microbiomes.
The aim of this study is to address this question through a pilot study of urinary and vaginal microbiomes in women with and without pubic hair AND in the same woman with and without pubic hair.
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Pre-menopausal women between the ages of 18-50
- English-speaking
- Women with either natural growth/distribution of pubic hair or complete removal of pubic hair through a reversible process.
- Women who do not feel they have urinary or vaginal health problems and are not seeking care for these issues
- Women must be willing and able to complete study documentation and study procedures.
Exclusion Criteria: Women will be excluded for any of the following:
- Hair has been removed through an irreversible process like laser or electrolysis
- Patient feels they have bothersome urinary or pelvic floor conditions for which they are seeking care (for example: vaginal prolapse, frequent urinary incontinence, chronic pelvic pain, bladder pain)
- Patient plans on having any type of surgery in the next 2 months (due to likely antibiotic use)
- Patient has a history of a transplant and is on immunosuppression
- Patient has cancer for which she is currently getting chemotherapy or radiation
- Currently taking or has taken antibiotics in the last 7 days for any reason
- Patient has symptoms of a urinary tract or vaginal infection or is found on exam or culture to have a urinary tract infection or vaginal infection
- Patient is pregnant or breastfeeding
- Patient has douched in the last 48 hours
- Patient has had intercourse in the last 48 hours
- Patient is currently menstruating
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Natural Pubic Hair
Participant with natural hair crosses over to removed pubic hair
|
Natural pubic hair to fully removed pubic hair
|
Other: Removed Pubic Hair
Participant with no pubic hair crosses over to natural pubic hair
|
Removed pubic hair to natural pubic hair
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of Urinary and Vaginal Microbiomes
Time Frame: up to 3 months
|
Describe and compare the urinary and vaginal microbiome in the same woman with natural pubic hair and with fully removed pubic hair
|
up to 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Questionnaire Comparison
Time Frame: up to 3 months
|
To compare questionnaire results for standardized patient surveys in the same woman with and without pubic hair
|
up to 3 months
|
Self-Reported Infections
Time Frame: up to 3 months
|
Comparing self-reported vaginal infections and urinary tract infections between women who have natural pubic hair and women who fully remove their pubic hair
|
up to 3 months
|
Subtracting Microbiome Results
Time Frame: up to 3 months
|
To suggest whether the transurethral urinary microbiome can be determined by subtracting the vaginal microbiome from the voided urinary microbiome
|
up to 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Margaret G Mueller, MD, Northwestern University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2017
Primary Completion (Actual)
June 14, 2019
Study Completion (Actual)
June 14, 2019
Study Registration Dates
First Submitted
August 18, 2017
First Submitted That Met QC Criteria
September 1, 2017
First Posted (Actual)
September 5, 2017
Study Record Updates
Last Update Posted (Actual)
June 4, 2020
Last Update Submitted That Met QC Criteria
June 3, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- STU00205206
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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