Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
NCT number |
NCT05897086 |
Other study ID # |
221616 |
Secondary ID |
|
Status |
Enrolling by invitation |
Phase |
Phase 2/Phase 3
|
First received |
|
Last updated |
|
Start date |
August 1, 2021 |
Est. completion date |
December 1, 2026 |
Study information
Verified date |
September 2023 |
Source |
Vanderbilt University Medical Center |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Phalloplasty, a genitourinary surgery for transmasculine patients, reconstructs a neophallus
using tissue transferred from other parts of the body to the groin. However, this technique
fails to provide adequate sensation, causing regret and persistent dysphoria. Peripheral
nerve regeneration is the greatest barrier to sensory recovery, given the slow rate of
regrowth coupled with the negative effects of axonal degeneration. Topical application of
polyethylene glycol (PEG) fuses severed axonal membranes, restoring the nerve's immediate
ability to conduct electrical signals across the repair site. The investigators hypothesize
that utilizing PEG in phalloplasties will significantly improve neophallus sensation and
postoperative quality of life.
Description:
With more than 1.6 million transgender and nonbinary (TGNB) individuals in the United States,
the investigators have witnessed an exponential increase in the number of gender-affirming
surgeries performed in the last 2 decades. Of the affirming surgical spectrum, "bottom"
genitourinary surgeries remain the most challenging. Specifically, phalloplasty is a
masculinizing surgery for neophallus creation using free tissue transfer from other parts of
the body and microvascular techniques for nerve and vessel reattachment. In radial forearm
free flap (RFFF) phalloplasty, nerves from the forearm are harvested with the flap and
sutured to nerves in the groin to provide postoperative sensation in the neophallus. Despite
transmasculine patients ranking sensation as one of their top priorities, standard nerve
coaptations performed in phalloplasty fail to provide consistent sensation with scarce
dedicated research aimed at enhancing neophallus sensory outcomes. Without scientific
advances, phalloplasty will remain far from perfect, negatively affecting patients' sexual
health, causing dissatisfaction, and increasing the risk of surgical regret and persistent
dysphoria.
Peripheral nerve regeneration remains the limiting factor for ideal sensory recovery due to
the slow and inconsistent rates of regeneration, and the negative effects of axonal
degeneration that occurs post-injury. The investigators advocate for using polyethylene
glycol as a "fusogen" to achieve nerve fusion in peripheral nerve coaptations. Polyethylene
glycol (PEG) is a hydrophilic compound that enhances the fusion of the lipid bilayer membrane
of severed axons, restoring the nerve's immediate ability to conduct electrical signals
across the repair site. The investigators have conducted extensive mammalian and preliminary
human studies using our novel PEG-fusion protocol for nerve coaptations. In both ex-vivo and
in-vivo studies in rats with severed sciatic nerves, PEG-assisted nerve coaptation restored
morphological continuity and led to a remarkable early improvement in functional outcomes. In
the first human PEG fusion of injured digital nerves performed by our team, the investigators
saw rapid nerve recovery and early functional outcomes as early as one week. Based on the
investigator's experience with PEG fusion, the investigators will be conducting a randomized
clinical trial to test the efficacy of PEG-assisted nerve coaptation in achieving superior
neophallus sensory function following phalloplasty.