Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Behaviors and Mental Disorders

Symptoms and General Pathology

Prostatic Neoplasms

Erectile Dysfunction

Urinary Incontinence

Enuresis

Nocturnal Enuresis

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Male Urogenital Diseases

Sexual Dysfunction, Physiological

Sexual Dysfunctions, Psychological

Mental Disorders

Psychotic Disorders

Urination Disorders

Urologic Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Lower Urinary Tract Symptoms

Urological Manifestations

Behavioral Symptoms

Elimination Disorders

Placement of a sheet of BioDFence G3 to the neurovascular bundle.

Placement of a sheet of BioDFence® G3 will be applied to the neurovascular bundle on participants undergoing an elective Full Nerve Sparing Radical Prostatectomy for primary treatment of prostate cancer.

BioDFence G3

Vipul R Patel, MD

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

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.

All of the patients will be recruited from patients seen in the principal investigator's (PI's) hospital and practice. The offer to participate will be extended to all eligible subjects for the importance of a representative sample.

No women, children or prisoners will be enrolled in this study.

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

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

De-identified information may be utilized in teachings and/or publication as it related to this research.

Outcome measured by the Sexual Health Inventory for Men (SHIM) score and patient reported potency erectile function score.

Outcome measured by the American Urological Association (AUA ) score and patient reported number of urinary sanitation pads used daily.

Integra LifeSciences Corporation

AdventHealth

Dr. Vipul R. Patel

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
BioDFence® G3 For Full Nerve-Sparing Robotic-Assisted Radical Prostatectomy	NCT05363644	Prostate Cancer Prostatectomy Erectile Dysfun... Incontinence, U...	BioDFence G3	40 Years - 70 Years	AdventHealth
BioDFence® G3 For Full Nerve-Sparing Robotic-Assisted Radical Prostatectomy	NCT05363644	Prostate Cancer Prostatectomy Erectile Dysfun... Incontinence, U...	BioDFence G3	40 Years - 70 Years	AdventHealth

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