Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03823014 |
Other study ID # |
IRB-P00029965 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 1, 2019 |
Est. completion date |
July 1, 2022 |
Study information
Verified date |
July 2022 |
Source |
Boston Children's Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.