<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03272204</url>
  </required_header>
  <id_info>
    <org_study_id>STU00205206</org_study_id>
    <nct_id>NCT03272204</nct_id>
  </id_info>
  <brief_title>Pubic Hair and the Urinary and Vaginal Microbiome</brief_title>
  <official_title>Effects of Pubic Hair Grooming on Urinary and Vaginal Microbiome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Margaret Mueller</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northwestern University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research study seeks to find if there is a connection between the presence of pubic hair&#xD;
      and the type of bacteria that live in the vagina and bladder.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Urinary tract infections (UTIs) are the most common bacterial infections. In 2007, in the&#xD;
      United States alone, there were an estimated 10.5 million office visits for UTI symptoms&#xD;
      (constituting 0.9% of all ambulatory visits) and 2-3 million emergency department visits.&#xD;
      UTIs are significantly more common in women and are a leading cause of urogynecology&#xD;
      referrals. In women, the vagina plays a key role in the pathogenesis of UTIs. The initial&#xD;
      step in the pathogenesis of UTI is colonization of the vaginal opening and peri-urethra with&#xD;
      uropathogens from the intestinal microbiota, followed by ascension of uropathogens via the&#xD;
      urethra to the bladder and sometimes the kidneys to cause infection. Thus, understanding&#xD;
      factors that affect the microbiota of the vagina is key to understanding the pathogenesis of&#xD;
      UTI. Likewise, since Wolfe et al published the first evidence of a urinary microbiome in&#xD;
      2012, there has been growing interest in whether the content of this microbiome could&#xD;
      correlate with symptoms of the lower urinary tract. The urinary microbiome has been shown to&#xD;
      correlate with symptoms of urgency incontinence but to date, there is no data on whether the&#xD;
      composition of the urinary microbiome is associated with any change in risk for UTIs. If the&#xD;
      urinary microbiome could play a role in the acquisition of clinical infection, then the&#xD;
      factors that affect the microbiome of the bladder would be important in preventing UTIs. One&#xD;
      plausible and modifiable factor that may change the vaginal and urinary microbiome is the&#xD;
      presence of pubic hair. Hair in other parts of the body (nose, ears, eyebrows) traps and&#xD;
      stops the passage of pathogens into our mucous membranes. Additionally, the sebum produced by&#xD;
      hair follicles is bacteriostatic. However, some form of pubic hair grooming is performed by&#xD;
      the majority of pre-menopausal women (83%) and 62% of women between age 18-40 report having&#xD;
      removed ALL of their pubic hair at one point in life. This is predominantly done by using&#xD;
      non-electric razors (61%) but other women use lasers, waxing and depilatory creams.&#xD;
      Fifty-nine percent of women who perform pubic hair removal report their primary reason is to&#xD;
      improve hygiene. However, there is no data that this practice changes hygiene, with the&#xD;
      exception of preventing pubic hair lice. On the contrary, pubic hair removal has been&#xD;
      associated with skin injury leading to inoculation of bacteria and viruses. In a recent&#xD;
      cross-sectional study of pubic hair and sexually transmitted infections, researchers found&#xD;
      that frequent pubic hair grooming was correlated with a higher risk for sexually transmitted&#xD;
      infections (STIs). This preliminary work raises the question of whether the presence of pubic&#xD;
      hair affects the vaginal or urinary microbiome, thereby changing a woman's risk of infection&#xD;
      in either organ. Furthermore, specific pelvic floor disorders (PFDs) including painful&#xD;
      bladder syndrome and urgency urinary incontinence have been associated with specific&#xD;
      microbiome profiles. Therefore, by falsely attempting to maintain pelvic health through&#xD;
      grooming practices, women might inadvertently be exposing themselves to PFDs mediated by&#xD;
      changes in their urinary or vaginal microbiomes. The aim of this study is to address this&#xD;
      question through a pilot study of urinary and vaginal microbiomes in women with and without&#xD;
      pubic hair AND in the same woman with and without pubic hair.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">June 14, 2019</completion_date>
  <primary_completion_date type="Actual">June 14, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of Urinary and Vaginal Microbiomes</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Describe and compare the urinary and vaginal microbiome in the same woman with natural pubic hair and with fully removed pubic hair</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Questionnaire Comparison</measure>
    <time_frame>up to 3 months</time_frame>
    <description>To compare questionnaire results for standardized patient surveys in the same woman with and without pubic hair</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Reported Infections</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Comparing self-reported vaginal infections and urinary tract infections between women who have natural pubic hair and women who fully remove their pubic hair</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subtracting Microbiome Results</measure>
    <time_frame>up to 3 months</time_frame>
    <description>To suggest whether the transurethral urinary microbiome can be determined by subtracting the vaginal microbiome from the voided urinary microbiome</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Natural Pubic Hair</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participant with natural hair crosses over to removed pubic hair</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Removed Pubic Hair</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participant with no pubic hair crosses over to natural pubic hair</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>No pubic hair</intervention_name>
    <description>Natural pubic hair to fully removed pubic hair</description>
    <arm_group_label>Natural Pubic Hair</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Pubic Hair</intervention_name>
    <description>Removed pubic hair to natural pubic hair</description>
    <arm_group_label>Removed Pubic Hair</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pre-menopausal women between the ages of 18-50&#xD;
&#xD;
          -  English-speaking&#xD;
&#xD;
          -  Women with either natural growth/distribution of pubic hair or complete removal of&#xD;
             pubic hair through a reversible process.&#xD;
&#xD;
          -  Women who do not feel they have urinary or vaginal health problems and are not seeking&#xD;
             care for these issues&#xD;
&#xD;
          -  Women must be willing and able to complete study documentation and study procedures.&#xD;
&#xD;
        Exclusion Criteria: Women will be excluded for any of the following:&#xD;
&#xD;
          -  Hair has been removed through an irreversible process like laser or electrolysis&#xD;
&#xD;
          -  Patient feels they have bothersome urinary or pelvic floor conditions for which they&#xD;
             are seeking care (for example: vaginal prolapse, frequent urinary incontinence,&#xD;
             chronic pelvic pain, bladder pain)&#xD;
&#xD;
          -  Patient plans on having any type of surgery in the next 2 months (due to likely&#xD;
             antibiotic use)&#xD;
&#xD;
          -  Patient has a history of a transplant and is on immunosuppression&#xD;
&#xD;
          -  Patient has cancer for which she is currently getting chemotherapy or radiation&#xD;
&#xD;
          -  Currently taking or has taken antibiotics in the last 7 days for any reason&#xD;
&#xD;
          -  Patient has symptoms of a urinary tract or vaginal infection or is found on exam or&#xD;
             culture to have a urinary tract infection or vaginal infection&#xD;
&#xD;
          -  Patient is pregnant or breastfeeding&#xD;
&#xD;
          -  Patient has douched in the last 48 hours&#xD;
&#xD;
          -  Patient has had intercourse in the last 48 hours&#xD;
&#xD;
          -  Patient is currently menstruating&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Margaret G Mueller, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>June 3, 2020</last_update_submitted>
  <last_update_submitted_qc>June 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Margaret Mueller</investigator_full_name>
    <investigator_title>Assistant Professor of Obstetrics and Gynecology, Urology</investigator_title>
  </responsible_party>
  <keyword>pubic hair; grooming; urinary tract symptoms; vaginitis</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03272204
org study id: STU00205206
nct id: NCT03272204
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Comparison of Urinary and Vaginal Microbiomes
time frame: up to 3 months
description: Describe and compare the urinary and vaginal microbiome in the same woman with natural pubic hair and with fully removed pubic hair
measure: Questionnaire Comparison
time frame: up to 3 months
description: To compare questionnaire results for standardized patient surveys in the same woman with and without pubic hair
measure: Self-Reported Infections
time frame: up to 3 months
description: Comparing self-reported vaginal infections and urinary tract infections between women who have natural pubic hair and women who fully remove their pubic hair
measure: Subtracting Microbiome Results
time frame: up to 3 months
description: To suggest whether the transurethral urinary microbiome can be determined by subtracting the vaginal microbiome from the voided urinary microbiome
arm group label: Natural Pubic Hair
arm group type: Other
description: Participant with natural hair crosses over to removed pubic hair
arm group label: Removed Pubic Hair
arm group type: Other
description: Participant with no pubic hair crosses over to natural pubic hair
intervention type: Behavioral
intervention name: No pubic hair
description: Natural pubic hair to fully removed pubic hair
arm group label: Natural Pubic Hair
intervention type: Behavioral
intervention name: Pubic Hair
description: Removed pubic hair to natural pubic hair
arm group label: Removed Pubic Hair
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Margaret G Mueller, MD
role: Principal Investigator
affiliation: Northwestern University
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Northwestern University
investigator full name: Margaret Mueller
investigator title: Assistant Professor of Obstetrics and Gynecology, Urology