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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
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 • NCT030605123%
Flatulence
2%
Nausea
2%
Abdominal pain
1%
Urinary tract infection
1%
Abdominal pain upper
1%
Diarrhoea
1%
Vertigo
1%
Gastroenteritis
1%
Laceration
1%
Vomiting
1%
Abdominal distension
1%
Back pain
100%
80%
60%
40%
20%
0%
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
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.
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.
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
900 Previous Clinical Trials
939,476 Total Patients Enrolled
Wesley Thayer, MDPrincipal InvestigatorVanderbilt University Medical Center
2 Previous Clinical Trials
18 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a blood clot, stroke, or heart attack in the last 6 months.I am diagnosed with gender dysphoria and planning to undergo forearm flap surgery for phalloplasty.I am over 18 years old.I am willing to follow all treatment and study check-up plans.
Research Study Groups:
This trial has the following groups:- Group 1: Control (No Intervention)
- Group 2: Experimental
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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