The purpose of this research is to determine the effectiveness of using human Umbilical Cord (UC) allograft to help improve return to erectile function and bladder control in patients following robot-assisted radical prostatectomy (RARP).
Participation in this study will involve MLG (Multi-Layered Perinatal Tissue Allograft) allograft, which is implanted during the surgery. This allograft is currently FDA approved and used for several type of surgeries. The Multi-Layered Perinatal Tissue Allograft- (MLG) is processed from tissue according to the American Association of Tissue Banks (AATB) standards, and is regulated as a cell, tissue, or cellular or tissue-based product (HCT/P) under Section 361 of the Public Health Service Act. The grafts are distributed by Samaritan Biologics, LLC; an FDA-registered tissue bank. The MLG allograft will be placed on each neurovascular bundle (NVB) bilaterally. MLG is supplied as sterile sheets having dimensions of 2cm x 2cm and a thickness of approximately 0.8-1.0mm thick. Participants receiving MLG will have it placed around the neurovascular bundle. Placement of the graft should not take over 5 minutes of time to impact overall surgical time length significantly.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
MLG allografts contains more than 450 bioactive proteins including growth factors and cytokines known to modulate inflammation and promote tissue healing. MLG is supplied as sterile sheets having dimensions of 2cm x 2cm and a thickness of approximately 0.8-1.0mm thick. Participants receiving MLG will have it placed around the neurovascular bundle. Placement of the graft should not take over 5 minutes of time to impact overall surgical time length significantly.
Average time for return to potency
Early recovery in potency will be measured as + 4 points of total Sexual Health Inventory for Men (SHIM) score in relation to baseline score. Return to potency will be defined as the ability to achieve an erection sufficient for intercourse more than 50% of the time or at least 50% rigidity post-robot-assisted radical prostatectomy (RARP) (Tool: SHIM, Q2 \> 3)
Time frame: 1 month post-op
Average time for return to potency
Early recovery in potency will be measured as + 4 points of total SHIM score in relation to baseline score. Return to potency will be defined as the ability to achieve an erection sufficient for intercourse more than 50% of the time or at least 50% rigidity post-RARP (Tool: SHIM, Q2 \> 3)
Time frame: 3 month post-op
Average time for return to potency
Early recovery in potency will be measured as + 4 points of total SHIM score in relation to baseline score. Return to potency will be defined as the ability to achieve an erection sufficient for intercourse more than 50% of the time or at least 50% rigidity post-RARP (Tool: SHIM, Q2 \> 3)
Time frame: 6 month post-op
Average time for return to potency
Early recovery in potency will be measured as + 4 points of total SHIM score in relation to baseline score. Return to potency will be defined as the ability to achieve an erection sufficient for intercourse more than 50% of the time or at least 50% rigidity post-RARP (Tool: SHIM, Q2 \> 3)
Time frame: 12 month post-op
Average time for return to continence
Return to continence will be defined as use of \< 1 pad post-RARP
Time frame: 1-2 days post-op
Average time for return to continence
Return to continence will be defined as use of \< 1 pad post-RARP
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Time frame: 1 month post-op
Average time for return to continence
Return to continence will be defined as use of \< 1 pad post-RARP
Time frame: 3 month post-op
Average time for return to continence
Return to continence will be defined as use of \< 1 pad post-RARP
Time frame: 6 month post-op
Average time for return to continence
Return to continence will be defined as use of \< 1 pad post-RARP
Time frame: 12 month post-op
Expanded prostate cancer index composite-26 (EPIC-26) Score
EPIC-26, contains five symptom domains (urinary incontinence, urinary irritative/obstructive, sexual, bowel, hormonal), scored from 0 (worst) to 100 (best)
Time frame: Months 1, 3, 6, and 12
Abdominal VAS (Visual Analog Scale) Pain Score
VAS score 0 -10: 0 indicating no abdominal pain to 10 as worst pain
Time frame: Post-op Days 1 and 2
Value analysis for a historical subset of patients who underwent same surgery as sexual health inventory for men (SHIM)-matched controls
Twenty-five patients who underwent bilateral nerve sparing in the past matched by preoperative SHIM to see how they did in comparison to study cohort will be measured as + 4 points of total SHIM score in relation to baseline score. Return to potency will be defined as the ability to achieve an erection sufficient for intercourse more than 50% of the time or at least 50% rigidity post-RARP (Tool: SHIM, Q2 \> 3)
Time frame: Month 1 post-op
Costs of prescription
Oral Phosphodiesterase type 5 (PDE-5i), Intracavernosal injection, Alprostadil urethral suppository or future surgery (Inflatable penile prosthesis) to be recorded in the historical group of 25 patients. Overall expense will be measured by reviewing history. A market value of medication and treatment will be accounted. Post coverage out of pocket expense will not be reviewed separately.
Time frame: Month 12 post-op
Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) scores
Overall patient satisfaction Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) - composed of 29 items - the survey contains 19 core questions about critical aspects of patients' hospital experiences (communication with nurses and doctors, the responsiveness of hospital staff, the cleanliness and quietness of the hospital environment, communication about medicines, discharge information, overall rating of hospital, and would they recommend the hospital) - HCAHPS score is accounted as The "top-box" score indicates how often patients selected the most positive response category when asked about their hospital experience. The higher a hospital's "top-box" score, the higher it ranks.
Time frame: Day 1 post-op