BioDFence® G3 For Full Nerve-Sparing Robotic-Assisted Radical Prostatectomy

Prostate Cancer Clinical Trial

Official title: Treatment Protocol With BioDFence® G3 For Full Nerve-Sparing Robotic-Assisted Radical Prostatectomy: A Prospective Open Label Single-Center Study

Status Withdrawn

Clinical Trial Summary

The purpose of this study is to assess functional outcomes post operatively after the use of BioDFence® G3 during robotic radical prostatectomy.

Clinical Trial Description

The purpose of this study is to build on our experience of amniotic membrane use in Robotic Assisted Radical Prostatectomy for prostate cancer, we aim to evaluate clinical outcomes related to the use of BioDFence® G3; a tri-layered amniotic membrane. BioDFence® G3 is regulated by the FDA as a 361 HCT/P for use from head to toe as a tissue barrier for soft tissue repair and as a wound covering.

For the purpose of this study BioDFence® G3 will be placed on the neurovascular bundles by the surgeon during the robotic assisted radical prostatectomy procedure that the participant has elected as their primary treatment for prostate cancer. The potential benefits that will be assessed are an earlier return of potency after surgery as evidenced by The Sexual Health Inventory for Men (SHIM) questionnaire score and self-reported sexual function and secondarily looking at continence outcomes measured by The American Urological Association (AUA) questionnaire form and self-reported urinary function. ;

Related Conditions & MeSH terms

• Enuresis
• Erectile Dysfunction
• Erectile Dysfunction Following Radical Prostatectomy
• Incontinence, Urinary
• Prostate Cancer
• Prostatectomy
• Urinary Incontinence

• NCT number: NCT05363644
• Study type: Interventional
• Source: AdventHealth
• Status: Withdrawn
• Phase: Phase 3
• Start date: April 1, 2023
• Completion date: June 30, 2024