The purpose of this research study is to evaluate if placing a dehydrated human amnion chorion membrane (dHACM) over the nerves after removal of the prostate during surgery (radical prostatectomy) will allow an earlier recovery of erectile function and urinary control after surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
118
The BioDFence G3 Placental Tissue Membrane is a three-layer tissue allograft consisting of amnion-chorion-amnion. Amniotic membranes will be placed over the neurovascular bundle after extirpative RARP. The membrane will be cut into two longitudinal pieces and placed over each neurovascular bundle separately.
Robot-assisted surgical removal of the prostate, administered standard of care.
University of Miami
Miami, Florida, United States
Change in Erectile Function Recovery as Measured by EPIC26 Sexual Domain Score
Erectile function recovery among participants will be measured by the change in scores within the Sexual Domain of the Expanded Prostate Cancer Index Composite Short Form (EPIC26). The EPIC26 is a 26-item questionnaire used to measure health-related quality of life (HRQOL) among men with prostate cancer. The EPIC26 has five domains: Urinary Incontinence, Urinary Irritative/Obstructive, Bowel, Sexual, and Hormonal. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale with higher scores representing better HRQOL.
Time frame: Baseline, 12 Months Post-RARP
Change in Erectile Function Recovery as Measured by SHIM Score
Erectile function recovery among participants will be measured as the change in Sexual History Inventory for Men (SHIM). The SHIM is a health-related quality of life (HRQOL) questionnaire whose scores measure the severity of erectile dysfunction (ED) in men using points on a scale. The minimum score of 1 to 7 points indicates severe ED; a score of 8 to 11 points indicates moderate ED; a score of 12 to 15 points indicates mild-to-moderate ED; a score of 17 to 21 points indicates mild ED; and the maximum score of 22 to 25 points indicates no significant ED.
Time frame: Baseline, 12 Months Post-RARP
Change in Proportion of Men with Mild ED or Better as Defined by EPIC26 Sexual Domain Score
Proportion of men with mild ED or better as defined by an EPIC26 Sexual Domain score greater than or equal to 60. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale with higher scores representing better sexual function.
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP
Change in Proportion of Participants with mild ED or Better as Defined by SHIM Score
Proportion of participants with mild ED or better as defined by a SHIM score greater than or equal to 17. The SHIM is a health-related quality of life (HRQOL) questionnaire whose scores measure the severity of erectile dysfunction (ED) in men using points on a scale. The minimum score of 1 to 7 points indicates severe ED; a score of 8 to 11 points indicates moderate ED; a score of 12 to 15 points indicates mild-to-moderate ED; a score of 17 to 21 points indicates mild ED; and the maximum score of 22 to 25 points indicates no significant ED.
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Time frame: Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP
Change in Proportion of Participants with Erections Adequate for Penetration ≥ 50% of the time
Proportion of participants with erections adequate for penetration greater than or equal to 50-percent of the time.
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP
Change in Proportion of Participants who Require the Use of More Invasive Erectile Aids
Proportion of participants who require the use of more invasive erectile aids (intra-cavernosal injection, vacuum pump, or penile prosthesis).
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP
Change in Rate of Urinary Control
Rate of urinary control as measured by EPIC26 question 3 that reports the number of participants requiring no pads per day.
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP
Change in Biochemical Failure
Biochemical failure among participants will measured as a prostate-specific antigen (PSA) level \> 0.2 ng/ml on two consecutive samples.
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP
Number of Treatment-Related Adverse Events
The number of treatment-related adverse events among participants will be assessed by treating physician using the Clavien-Dindo grading scale.
Time frame: Up to 12 months post-RARP