The purpose of this research is to determine if using human placental membrane (also called an allograft) helps to improve recovery time for erectile function and bladder control after having robot-assisted radical prostatectomy (RARP) surgery.
Primary Objective(s): * To evaluate the safety and feasibility of MLG-Complete™ allograft placement in patients who undergo robot-assisted radical prostatectomy (RARP) with bilateral nerve sparing. * To determine the effectiveness of using MLG-Complete™ allograft to optimize return to erectile function (potency) in patients who have had robot-assisted radical prostatectomy (RARP) with bilateral nerve sparing by utilizing the Sexual Health Inventory for Men (SHIM) score. * To determine the effectiveness of using MLG-Complete™ allograft to optimize return to continence in patients who have had robot-assisted radical prostatectomy (RARP) with bilateral nerve sparing by utilizing the American Urological Association (AUA) symptom score, assessing daily pad use from direct patient report, and by utilizing the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI Short Form). OUTLINE: Patients undergo RARP with placement of the MLG-Complete allograft on study. After completion of study treatment, patients are followed up at 1, 3, 6, and 12 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
The intervention will be administered on an inpatient basis. Participants receiving MLG-Complete™ will have it placed around the neurovascular bundle. Placement of the graft should not take more than 5 minutes, therefore, there should be minimal impact to overall surgical time.
The MLG-Complete™ allograft will be placed on each neurovascular bundle (NVB) bilaterally as shown on the above picture after excision of the prostate prior to completing the urethrovesical anastomosis.
Number of Adverse Events Using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Safety will be assessed by describing the frequency and nature of adverse events using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 throughout the study
Time frame: Up to 12 months
Number of Adverse Events Using the Clavien-Dindo Classification System
Adverse effects per the Clavien-Dindo Classification system will be assessed descriptively post-graft placement The Clavien-Dindo system is widely used throughout surgery for grading adverse events (i.e. complications) which occur as a result of surgical procedures. It consists of 7 grades. Grade I - Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions; Grade II - Requiring pharmacological treatment with drugs other than such allowed for grade I complications Grade III - Requiring surgical, endoscopic or radiological intervention * IIIa - Intervention not under general anesthesia * IIIb - Intervention under general anesthesia; Grade IV - Life-threatening complication (including central nervous system complications) requiring intensive care/intensive care unit-management * IVa - single organ dysfunction (including dialysis) * IVb - Multi-organ dysfunction and Grade V - Death
Time frame: Up to 12 months
Number of Participants Screened for Enrollment
Feasibility will be assessed by determining the number of patients screened in order to enroll the anticipated number of participants to study intervention.
Time frame: Up to 12 months
Number of Participants to Complete Intervention
Rates of completion will be determined at each visit based on the anticipated number of participants to study intervention that complete each visit.
Time frame: Up to 12 months
Average Time for Participants to Return to Potency - Sexual Health Inventory for Men (SHIM) Questionnaire
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Return to potency will be defined as the time to attain the ability to achieve an erection sufficient for intercourse \>50% of the time or at least 50% rigidity compared to baseline status post robot-assisted radical prostatectomy using the Sexual Health Inventory for Men (SHIM) questionnaire. This questionnaire is used to diagnose erectile dysfunction (ED) and severity as moderate score ranging 8-11, mild to moderate 12-16, 17-21 mild, and 22-25 no ED
Time frame: Up to 12 months
Average Time to Return to Bladder Control/Urinary Continence - ICIQ-UI Short Form
effectiveness will be measured by the average time for return to continence as defined as the time from radical prostatectomy to until the use of \< 1 incontinence pad and by the and by the ICIQ-UI Short Form. This tool is a four-item questionnaire to objectively evaluate urinary incontinence (UI) and its associated impact on quality of life. Scores range from 0-21 with a higher score indicating greater severity.
Time frame: Up to 12 months