HealthyNCT03272204
Pubic Hair and the Urinary and Vaginal Microbiome
A study testing No pubic hair and Pubic Hair in people with Healthy, run by Margaret Mueller at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- No pubic hair and Pubic Hair
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 14 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
Show all 17Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- No pubic hair, Pubic Hair
- Keywords
- pubic hair; grooming; urinary tract symptoms; vaginitis
- Medical subject headings
- Grooming, Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No pubic hairBehavioural
Natural pubic hair to fully removed pubic hair
Pubic HairBehavioural
Removed pubic hair to natural pubic hair
| Study group | Role | What they receive |
|---|---|---|
| Natural Pubic Hair | Other | Participant with natural hair crosses over to removed pubic hair Receives: Behavioral: No pubic hair |
| Removed Pubic Hair | Other | Participant with no pubic hair crosses over to natural pubic hair Receives: Behavioral: Pubic Hair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Urinary and Vaginal Microbiomes
Describe and compare the urinary and vaginal microbiome in the same woman with natural pubic hair and with fully removed pubic hair
Measured: up to 3 months
Secondary outcomes (3)
Questionnaire Comparison
To compare questionnaire results for standardized patient surveys in the same woman with and without pubic hair
Measured: up to 3 months
Self-Reported Infections
Comparing self-reported vaginal infections and urinary tract infections between women who have natural pubic hair and women who fully remove their pubic hair
Measured: up to 3 months
Subtracting Microbiome Results
To suggest whether the transurethral urinary microbiome can be determined by subtracting the vaginal microbiome from the voided urinary microbiome
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start1 Oct 2017
- Primary completion14 Jun 2019
- Study completion14 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Margaret Mueller
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Margaret Mueller, Northwestern University
- Investigators
- Margaret G Mueller, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03272204
- Sponsor's protocol ID
- STU00205206
- Status last verified
- Jun 2020
- First submitted
- 18 Aug 2017
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Geynisman-Tan J, Kenton K, Tavathia M, Yee A, Gilbert JA, Collins S, Lewicky-Gaupp C, Mueller M. Bare Versus Hair: Do Pubic Hair Grooming Preferences Dictate the Urogenital Microbiome? Female Pelvic Med Reconstr Surg. 2021 Sep 1;27(9):532-537. doi: 10.1097/SPV.0000000000000968.
PubMed 33181518
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pubic Hair Grooming on Urinary and Vaginal Microbiome
- ClinicalTrials.gov ID
- NCT03272204
- Acronym / sponsor ID
- STU00205206
- Conditions
- Healthy
- Keywords
- pubic hair; grooming; urinary tract symptoms; vaginitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Margaret MuellerUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 14 Jun 2019 (actual)
- Study completion
- 14 Jun 2019 (actual)
- First posted
- 5 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Natural Pubic Hair | Other | Behavioral: No pubic hairParticipant with natural hair crosses over to removed pubic hair |
| Removed Pubic Hair | Other | Behavioral: Pubic HairParticipant with no pubic hair crosses over to natural pubic hair |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No pubic hairNatural pubic hair to fully removed pubic hair | Behavioural | Natural Pubic Hair |
| Pubic HairRemoved pubic hair to natural pubic hair | Behavioural | Removed Pubic Hair |
Primary outcome
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
3 secondary outcomes
Questionnaire Comparison
Time frame: up to 3 months
Self-Reported Infections
Time frame: up to 3 months
Subtracting Microbiome Results
Time frame: up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Derived from this study: PubMed 33181518Geynisman-Tan J, Kenton K, Tavathia M, Yee A, Gilbert JA, Collins S, Lewicky-Gaupp C, Mueller M. Bare Versus Hair: Do Pubic Hair Grooming Preferences Dictate the Urogenital Microbiome? Female Pelvic Med Reconstr Surg. 2021 Sep 1;27(9):532-537. doi: 10.1097/SPV.0000000000000968.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret G Mueller, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No pubic hair and Pubic Hair in people with Healthy, run by Margaret Mueller at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Urinary and Vaginal Microbiomes (time frame: up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03272204, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.