Feasibility and Effect of Wrapping Nerves With a Multi-Layer Perinatal Tissue Allograft During Prostatectomy

Inclusion criteria

• Male subjects with age ≥ 45
• Primary diagnosis of prostate cancer selected for surgical intervention (radical prostatectomy)
• Primary diagnosis of organ confined (i.e. localized) untreated prostate cancer
• Planned elective radical prostatectomy with bilateral nerve sparing technique
• Negative urinalysis within 30 days prior to date of surgery
• Patient has no erectile dysfunction (SHIM score ≥ 19) at the time of consultation
• Willing to comply with instruction of the investigator
• Willing to comply with follow-up surveys
• Ability to provide written consent
• Negative urinary tract infection at the time of consultation
• Interest in penetrative sexual intercourse

Exclusion criteria

• High-risk cancer planned for neoadjuvant therapy, full or partial excision of neurovascular bundles
• Unable to comply with learning and documenting penile rehabilitation, including oral 5-phosphodiesterase inhibitor use, vacuum pump therapy use, and/or injectable medications
• History of >14 days treatment with immunosuppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period
• Prior hormonal therapy such as Lupron or oral anti-androgens
• Poor urinary control at baseline requiring the use of pads for leakage
• Previous history of pelvic radiation
• Previous history of simple prostatectomy or transurethral prostate surgery
• Patients with obesity defined as body mass index (BMI) > 40 kg/m^2
• History of open pelvic surgery ≤ 5 prior to registration (except for hernia repair)
• Scheduled to undergo chemotherapy, radiation, hormone therapy, or open surgery during the study period
• Any neurologic disorder or psychiatric disorder that might confound postsurgical assessments
• Has any condition(s) which seriously compromises the subject's ability to participate in this study, sign consent, or has a known history of poor adherence with medical treatment
• In the opinion of the principal investigator (PI), has a history of drug or alcohol abuse ≤ 12 months prior to registration
• Allergic to aminoglycoside antibiotics (such as gentamicin and/or streptomycin)
• Received administration of an investigational drug within 30 days prior to registration, and/or has planned administration of another investigational product or procedure during participation in this study