Injuries to the genitalia are of concern to the military with emphasis placed on the surgical reconstruction and psychological health of these Wounded Warriors. However, despite significant surgical advances in microvascular surgery and autologous free tissue transfer, conventional reconstructions cannot truly replace the complicated structures and functions of the penis including the urethra, erogenous sensation, and erectile corporal bodies. Conventional reconstruction poses several challenges: patients may not have sufficient donor tissue due to other injuries or previous surgery; multiple operations are often needed to restore the neophallus; the final reconstruction only approximates the penis' native form; recreating the urethra is challenging and the new urethra is prone to stricture and fistula formation; the erectile function necessary for sexual intercourse is often lacking; and insufficient protective sensation can lead to penile implant extrusion, infection, subsequent explantation or loss of the reconstruction. The investigators propose this clinical trial to determine functional outcomes and quality of life for Wounded Warriors and civilians who choose to undergo penile allotransplantation. The investigators will combine extensive experience performing total penile reconstruction in a large population affected by congenital, traumatic, and therapeutically extirpated Genitourinary deformities and expertise in reconstructive transplantation using an immunomodulatory protocol to for this study. The investigators anticipate penile transplantation can potentially replace "like with like," restoring the appearance, anatomy, and function of the recipient in a manner far superior to autologous reconstruction. This project will establish the ability to perform penile allotransplantation using an immunomodulatory protocol and will compare outcomes with conventional phalloplasty patient results. Study Design: This is a non-randomized subject self-controlled clinical trial to implement a cell-based immunomodulatory protocol for penile allotransplantation. An intermediate deliverable is achieving allograft survival and functional return with reduced dosing/frequency of maintenance immunosuppression on steroid-free monotherapy (tacrolimus) immunosuppression. The long-term deliverable and goal is to demonstrate superior outcomes when compared to satisfaction and QOL in conventional phalloplasty patients 12-60 months post-transplant.
Specific Aims: 1) To assess the feasibility and function of penile allotransplantation in Wounded Warriors and civilians who have lost their penis due to battle or traumatic injury, using an immunomodulatory protocol to reduce immunosuppression; 2) To assess pre-to-post changes in QOL in patients who undergo penile allotransplantation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
RECRUITINGAllograft Survival
use an immunomodulatory protocol to reduce immunosuppression. Post-operative allograft survival will be assessed by various clinical measures including: physical assessments, imaging assessments (ultrasound, CT angiography, magnetic resonance (MR) Neurography and MRI) immune monitoring (screen patient sera for donor specific antibodies), hematologic and metabolic tests, viral tests, chimerism tests, and skin biopsies
Time frame: Transplantation through end of study period (up to 5 years)
Quality of Life (QOL) as assessed by Brief Symptom Inventory
Brief Symptom Inventory questionnaire evaluates psychological distress and psychiatric disorders. It consists of 53-item self-report inventory in which participants rate the extent to which they have been bothered. 5-point rating scale, 0 indicating not at all bothered to 4 extremely bothered.
Time frame: Transplantation through end of study period ( 5 years)
QOL as assessed by Affect Balance Scale (ABS)
ABS is a 10-item questionnaire that assess positive and negative affect as indicators of life satisfaction and/or well-being. Score range from 0-4. 0 indicating the feeling never affected to 4, where the feeling is affected always.
Time frame: Transplantation through end of study period (up to 5 years)
QOL as assessed by NEO Five-Factor Inventory Scale (NEO-FFI)
NEO-FFI is used to examine personality traits. Questions consists of 60 items. Items are scored from Strongly disagree to Strongly agreed
Time frame: Transplantation through end of study period (up to 5 years)
QOL as assessed by the International Index of Erectile Function (IIEF)
A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction.
Time frame: Transplantation through end of study period (up to 5 years)
Psychosexual Measures assessed by Self-Esteem and Relationship (SEAR) questionnaire
14 item questionnaire where responses are scored from 1-5. Response of 1 indicating almost never/never to 5 indicating almost always/always
Time frame: Transplantation through end of study period ( 5 years)
T0 asses Erection Hardness Score (EHS)
EHS rates the hardness of erection on a scale of one to four, with four being the maximal score.
Time frame: Transplantation through end of study period ( 5 years)
Modified Sexual Life Quality Questionnaire-Quality of Life (mSLQQ- QoL)
Used to validate as a tool for evaluating sexual QoL. mSLQQ is measured from score of 0 to 8. 0 indicates a low score compare to 8, indicating high. A score of 4 indicates, nothing has been changed.
Time frame: Transplantation through end of study period ( 5 years)
Psychological Measures by Satisfaction with Life Scale (SWLS)
SWLS is a measure of life satisfaction. Uses scale to rate from 1-7, Where 1 indicates Strongly disagree to 7 indicating strongly agree.
Time frame: Transplantation through end of study period ( 5 years)
Brief Pain Inventory (Short Form) ) (BPISF)
BPISF assesses the severity of pain and its impact on functioning. It is scored from 0 to 10, 0 indicating no pain, does not interfere to 10 indicating pain as bad as you can imagine, completely interferes.
Time frame: Transplantation through end of study period ( 5 years)
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