<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/NCT03823014</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-P00029965</org_study_id>
    <nct_id>NCT03823014</nct_id>
  </id_info>
  <brief_title>Use of an External Erectile Device in Transgender Man Following Phalloplasty</brief_title>
  <acronym>ProstHEsis</acronym>
  <official_title>Use of an External Erectile Device in Transgender Man Following Phalloplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Children's Hospital</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>
      The purpose of this study is to test whether an external erectile prosthesis (The Elator™) is&#xD;
      a feasible alternative to internal erectile prostheses for transgender men who have undergone&#xD;
      a phalloplasty with glansplasty and wish to use their neophallus for sexual penetration. The&#xD;
      Elator™ was initially developed for men experiencing erectile dysfunction after prostate&#xD;
      cancer. The device consists of two silicone rings connected by a pair of plastic coated rigid&#xD;
      metal rods. One ring goes at the base of the penis. The other ring is connected to the rods.&#xD;
      This ring is placed behind the glans, and then the rods are connected to the base ring to&#xD;
      stretch and provide rigidity to the phallus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There are approximately 1.4 million transgender adults in the United States. Approximately&#xD;
      half are transgender men, individuals who have a male gender identity but were assigned&#xD;
      female at birth. A national survey of transgender adults found more than half of transgender&#xD;
      men have had, or may want, gender affirmation surgery in the form of phalloplasty - the&#xD;
      surgical creation of a penis and scrotum. The neophallus created in this manner can be used&#xD;
      for standing urination but not for penetrative sex, due to the lack of erectile structures.&#xD;
&#xD;
      Research suggests that one factor limiting interest in phalloplasty is the lack of reliable,&#xD;
      durable, and desirable erectile devices. Internal prostheses are the primary method used to&#xD;
      attain penile rigidity after phalloplasty. However, these devices carry a significant risk of&#xD;
      mechanical failure and other adverse events. The high failure and complication rates&#xD;
      associated with internal erectile prostheses demonstrate a need for alternative options for&#xD;
      transgender men after phalloplasty. One such option consists of an external erectile&#xD;
      prosthesis or support. The Elator™ consists of two silicone rings connected by a pair of&#xD;
      plastic coated rigid metal rods. Use of such an external device may be preferable for men who&#xD;
      do not wish to undergo additional surgery after phalloplasty, and/or those who have had&#xD;
      problems with internal prostheses.&#xD;
&#xD;
      Word of mouth suggests that a number of transgender men have experimented with these devices&#xD;
      after phalloplasty, but to date no study has tested the safety and function of external&#xD;
      erectile prostheses in this population. Currently, the FDA exempts most external penile&#xD;
      rigidity devices from pre-market notification and review. As such, safety and efficacy&#xD;
      testing is not required prior to public marketing. However, before medical professionals can&#xD;
      feel comfortable recommending these devices to their patients, such testing is clearly&#xD;
      indicated.&#xD;
&#xD;
      The proposed pilot study will test whether an external erectile prosthesis (The Elator™) is a&#xD;
      feasible alternative to internal erectile prostheses for transgender men after phalloplasty.&#xD;
      This study will recruit twenty men who have had a phalloplasty greater than one year prior to&#xD;
      the study date, have protective sensation to the tip of their phallus, have a current sexual&#xD;
      partner with whom they would like to explore sexual penetration using the neophallus, and who&#xD;
      do not currently have an internal erectile prosthesis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2019</start_date>
  <completion_date type="Actual">July 1, 2022</completion_date>
  <primary_completion_date type="Actual">July 1, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Pilot study to determine feasibility of device use for supportive care of transgender patients with erectile concerns post phalloplasty. Device is currently available in market.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Quality of Sexual Experience Scale</measure>
    <time_frame>Baseline and at study completion (~1.5 months)</time_frame>
    <description>Brief measure of quality of most recent sexual experience</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Relationship Satisfaction Subscale</measure>
    <time_frame>Baseline and at study completion (~1.5 months)</time_frame>
    <description>Measure of overall relationship satisfaction with romantic partner</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS)</measure>
    <time_frame>The intervention period of 4 weeks, assessed at study completion</time_frame>
    <description>Validated measure of satisfaction with erectile dysfunction treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Qualitative Device Feedback</measure>
    <time_frame>The intervention period of 4 weeks, assessed at study completion</time_frame>
    <description>Interview with men and their partners about the experience of using the device (optional)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Transsexualism</condition>
  <condition>Surgery</condition>
  <condition>Sex Behavior</condition>
  <condition>Erectile Dysfunction</condition>
  <arm_group>
    <arm_group_label>External Erectile Prosthesis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study participants will be recruited as couples (transgender man + sexual partner.) Couples will use an external erectile prosthesis (Elator) over the course of 1 month and keep track of their experiences. 20 men and their partners will be enrolled.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Elator</intervention_name>
    <description>Measurement for device, use of device</description>
    <arm_group_label>External Erectile Prosthesis</arm_group_label>
    <other_name>Erector</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary study subject must have had a phalloplasty with glansplasty a minimum of 1&#xD;
             year before enrollment and must have protective sensation to the tip of the phallus&#xD;
&#xD;
          -  Primary study subject must be in a relationship in which they are having, or would&#xD;
             like to have, penetrative sex with their partner. Partner must also be interested in&#xD;
             having penetrative sex with primary subject.&#xD;
&#xD;
          -  Both primary study subject and partner must have (individual) e-mail addresses and&#xD;
             access to the Internet to complete surveys&#xD;
&#xD;
          -  Primary study subject must be willing to be contacted by postal mail, in order to&#xD;
             receive the device&#xD;
&#xD;
          -  Both subjects must be willing to receive e-mails&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Either subject or partner does not speak English&#xD;
&#xD;
          -  Primary subject has an internal erectile prosthesis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Transgender men and their sexual partners (no gender/sex requirement)</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Participation in this study is from participants home.</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>July 20, 2022</last_update_submitted>
  <last_update_submitted_qc>July 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Children's Hospital</investigator_affiliation>
    <investigator_full_name>Elizabeth Boskey</investigator_full_name>
    <investigator_title>Researcher</investigator_title>
  </responsible_party>
  <keyword>transgender</keyword>
  <keyword>transmasculine</keyword>
  <keyword>ftm</keyword>
  <keyword>phalloplasty</keyword>
  <keyword>penile prosthesis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Erectile Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03823014
org study id: IRB-P00029965
nct id: NCT03823014
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to test whether an external erectile prosthesis (The Elator™) is
      a feasible alternative to internal erectile prostheses for transgender men who have undergone
      a phalloplasty with glansplasty and wish to use their neophallus for sexual penetration. The
      Elator™ was initially developed for men experiencing erectile dysfunction after prostate
      cancer. The device consists of two silicone rings connected by a pair of plastic coated rigid
      metal rods. One ring goes at the base of the penis. The other ring is connected to the rods.
      This ring is placed behind the glans, and then the rods are connected to the base ring to
      stretch and provide rigidity to the phallus.
There are approximately 1.4 million transgender adults in the United States. Approximately
      half are transgender men, individuals who have a male gender identity but were assigned
      female at birth. A national survey of transgender adults found more than half of transgender
      men have had, or may want, gender affirmation surgery in the form of phalloplasty - the
      surgical creation of a penis and scrotum. The neophallus created in this manner can be used
      for standing urination but not for penetrative sex, due to the lack of erectile structures.

      Research suggests that one factor limiting interest in phalloplasty is the lack of reliable,
      durable, and desirable erectile devices. Internal prostheses are the primary method used to
      attain penile rigidity after phalloplasty. However, these devices carry a significant risk of
      mechanical failure and other adverse events. The high failure and complication rates
      associated with internal erectile prostheses demonstrate a need for alternative options for
      transgender men after phalloplasty. One such option consists of an external erectile
      prosthesis or support. The Elator™ consists of two silicone rings connected by a pair of
      plastic coated rigid metal rods. Use of such an external device may be preferable for men who
      do not wish to undergo additional surgery after phalloplasty, and/or those who have had
      problems with internal prostheses.

      Word of mouth suggests that a number of transgender men have experimented with these devices
      after phalloplasty, but to date no study has tested the safety and function of external
      erectile prostheses in this population. Currently, the FDA exempts most external penile
      rigidity devices from pre-market notification and review. As such, safety and efficacy
      testing is not required prior to public marketing. However, before medical professionals can
      feel comfortable recommending these devices to their patients, such testing is clearly
      indicated.

      The proposed pilot study will test whether an external erectile prosthesis (The Elator™) is a
      feasible alternative to internal erectile prostheses for transgender men after phalloplasty.
      This study will recruit twenty men who have had a phalloplasty greater than one year prior to
      the study date, have protective sensation to the tip of their phallus, have a current sexual
      partner with whom they would like to explore sexual penetration using the neophallus, and who
      do not currently have an internal erectile prosthesis.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Pilot study to determine feasibility of device use for supportive care of transgender patients with erectile concerns post phalloplasty. Device is currently available in market.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in Quality of Sexual Experience Scale
time frame: Baseline and at study completion (~1.5 months)
description: Brief measure of quality of most recent sexual experience
measure: Change in Relationship Satisfaction Subscale
time frame: Baseline and at study completion (~1.5 months)
description: Measure of overall relationship satisfaction with romantic partner
measure: Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS)
time frame: The intervention period of 4 weeks, assessed at study completion
description: Validated measure of satisfaction with erectile dysfunction treatment
measure: Qualitative Device Feedback
time frame: The intervention period of 4 weeks, assessed at study completion
description: Interview with men and their partners about the experience of using the device (optional)
arm group label: External Erectile Prosthesis
arm group type: Experimental
description: Study participants will be recruited as couples (transgender man + sexual partner.) Couples will use an external erectile prosthesis (Elator) over the course of 1 month and keep track of their experiences. 20 men and their partners will be enrolled.
intervention type: Device
intervention name: Elator
description: Measurement for device, use of device
arm group label: External Erectile Prosthesis
other name: Erector
criteria: 
gender: All
gender based: Yes
gender description: Transgender men and their sexual partners (no gender/sex requirement)
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston Children's Hospital
investigator full name: Elizabeth Boskey
investigator title: Researcher
mesh term: Erectile Dysfunction
sharing ipd: No