RAP: Prospective Pilot Trial Evaluating Return to Continence and Potency Following Radical Prostatectomy Using Novel Multi-Layer Perinatal Tissue Allograft

NCT05742334 NA WITHDRAWN

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.

Details

Lead sponsor	Wake Forest University Health Sciences
Phase	NA
Status	WITHDRAWN
Start date	2023-07
Completion	2025-05

Conditions

• Prostate Cancer

Interventions

• Robot-Assisted Radical Prostatectomy with MLG-COMPLETE Allograft Implantation
• MLG-COMPLETE Allograft Implantation

Primary outcomes

• Number of Adverse Events Using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 — Up to 12 months
  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
• Number of Adverse Events Using the Clavien-Dindo Classification System — Up to 12 months
  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
• Number of Participants Screened for Enrollment — Up to 12 months
  Feasibility will be assessed by determining the number of patients screened in order to enroll the anticipated number of participants to study intervention.
• Number of Participants to Complete Intervention — Up to 12 months
  Rates of completion will be determined at each visit based on the anticipated number of participants to study intervention that complete each visit.
• Average Time for Participants to Return to Potency - Sexual Health Inventory for Men (SHIM) Questionnaire — Up to 12 months
  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
• Average Time to Return to Bladder Control/Urinary Continence - ICIQ-UI Short Form — Up to 12 months
  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.