Use of an External Erectile Device in Transgender Man Following Phalloplasty
Condition: Transsexualism; Surgery; Sex Behavior; Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Elator
Intervention type(s): Device
Intervention description(s): Measurement for device, use of device
Other intervention name(s): Erector
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.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: transgender; transmasculine; ftm; phalloplasty; penile prosthesis