What side effects are associated with this type of intervention?

Common treatments for Gender Dysphoria include hormone therapy, surgery, and psychological support. Hormone therapy can lead to side effects such as mood swings, weight gain, and cardiovascular issues. Surgical treatments, such as phalloplasty, can result in complications like infection, bleeding, and issues with wound healing. Specifically, nerve repair techniques using Polyethylene Glycol in surgeries aim to improve sensation but may still face challenges like incomplete nerve regeneration and potential for neuropathic pain. Psychological support is generally safe but may involve emotional distress during the transition process.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Gender Dysphoria that directly involve the use of Polyethylene Glycol for nerve repair. However, treatments for Gender Dysphoria typically include hormone replacement therapies such as testosterone and estrogen, which are FDA-approved for other indications but used off-label for gender transition. Surgical interventions, including phalloplasty and vaginoplasty, are also common but do not have specific FDA approval for the treatment of Gender Dysphoria. The use of PEG in phalloplasty to improve nerve regeneration and sensation is an emerging area of research and is not yet an FDA-approved treatment.

What other types of research exist?

Promising novel alternatives to Polyethylene Glycol for nerve repair in gender dysphoria patients include: 1) Nerve growth factor (NGF) therapies, which promote nerve regeneration and functional recovery. 2) Stem cell-based therapies, particularly those using mesenchymal stem cells (MSCs) or Schwann cells, which have shown potential in enhancing nerve repair. 3) Advanced biomaterials like graphene and nanofibers that support nerve growth and improve electrical conductivity. 4) Electrical stimulation devices that enhance nerve regeneration and functional recovery post-surgery.

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Nerve Repair with Polyethylene Glycol for Gender Dysphoria

Phase 2 & 3

Waitlist Available

Led By Wesley Thayer, MD

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests whether using a special substance during surgery can improve sensation in the new penis for patients. The substance helps nerves heal quickly, aiming to enhance the quality of life by providing better sensory outcomes.

Who is the study for?

This trial is for adults over 18 with gender dysphoria who are undergoing phalloplasty using tissue from their forearm. They must be willing to follow treatment and study evaluations for up to 15 months post-surgery. It's not for those allergic to PEG, with high hematocrit levels, or a history of blood clots, vein inflammation, recent stroke or heart attack.

What is being tested?

The trial tests if applying polyethylene glycol (PEG) during phalloplasty can improve sensation in the newly constructed neophallus. The goal is to see if PEG helps nerves heal better after surgery, potentially enhancing quality of life.

What are the potential side effects?

Specific side effects aren't listed here but may include reactions at the site where PEG is applied. Since participants have conditions excluding them based on allergies to PEG and certain cardiovascular risks, these factors could indicate potential areas of concern.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Medical Research Council Classification (MRCC)

Secondary study objectives

Sexual Functioning and Sensation Questionnaire

Vanderbilt Mini-PROM for Gender-Affirming Surgery(VMP-G)

Side effects data

From 2017 Phase 4 trial • 276 Patients • NCT03060512

Flatulence

Nausea

Abdominal pain

Urinary tract infection

Abdominal pain upper

Diarrhoea

Vertigo

Gastroenteritis

Laceration

Vomiting

Abdominal distension

Back pain

100%

80%

60%

40%

20%

Study treatment Arm

PEG 3350

Movantik

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ExperimentalExperimental Treatment1 Intervention

For the experimental group, after obtaining hemostasis, prior to neurorrhaphy, the operative field will be irrigated with calcium-free Plasmalyte A® (Baxter: Deerfield, IL) throughout the neurorrhaphy. At this point, the nerves will be repaired using standard suture neurorrhaphy techniques. Subsequently, approximately 1 or 2 drops of 5mg/ml (0.5%) methylene blue in sterile water solution are applied to the trimmed nerve endings. Then, approximately 2 ccs of a 190 mM solution of 50% PEG 3.35 kD in sterile water will be irrigated onto the neurorrhaphy site and the surgeon will wait one minute prior to continuing. Following this, the repaired nerve will be irrigated with calcium-containing Lactated Ringers (Hospira; Lake Forest, IL).

Group II: Control (No Intervention)Active Control1 Intervention

For the control groups, epineural repair will be undertaken in the standard end-to-end fashion using interrupted nylon suture after irrigation of the wound with normal saline as deemed necessary by the operating surgeon.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Polyethylene Glycol 3350

2023

Completed Phase 4

~510

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Gender Dysphoria include hormone therapy and surgical interventions. Hormone therapy involves administering estrogen or testosterone to induce physical changes that align with the patient's gender identity, thereby reducing dysphoria. Surgical interventions, such as phalloplasty or vaginoplasty, reconstruct genitalia to match the patient's gender identity. These treatments are crucial as they significantly alleviate psychological distress and improve overall quality of life. Polyethylene Glycol (PEG) is being studied for its potential to enhance nerve function in surgical procedures like phalloplasty by fusing severed axonal membranes, which could improve sensation and postoperative outcomes, addressing a critical aspect of surgical success and patient satisfaction.

Alterations in glial fibrillary acidic protein (GFAP) mRNA levels in the hamster facial motor nucleus: effects of axotomy and testosterone.Axotomy-induced changes in ribosomal RNA levels in female hamster facial motoneurons: differential effects of gender and androgen exposure.Restoration of motor function after operative reconstruction of the acutely transected spinal cord in the canine model.