NCT01832168
Completed
Not Applicable
A Prospective Randomized Clinical Trial Using Amniotic Membrane in Robotic Assisted Laparoscopic Prostatectomy (RALP)- Effect on Nerve Protection.
ConditionsPudendal Nerve
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pudendal Nerve
- Sponsor
- MiMedx Group, Inc.
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- The proportion of patients achieving return to baseline Sexual Health Inventory for Men (SHIM) score in the AmnioFix group versus the Control group.
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The purpose of this study is to determine whether the AmnioFix dehydrated human amniotic membrane is effective in protecting nerves in men receiving robotic assisted laparoscopic prostatectomies.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Clinically localized prostate cancer with Gleason score 6 or 7
- •SHIM Score greater than or equal to 16 in the absence of medication
- •Feasibility to perform unilateral or bilateral nerve sparing RALP
Exclusion Criteria
- •Clinically locally advanced cancer and/or with Gleason score 8 or
- •Difficulty performing nerve sparing RALP.
- •Prior surgery at the site.
- •Site exhibits clinical signs and symptoms of infection.
- •SHIM score at screening \<
- •Current use of anticoagulant medication including Coumadin, Plavix, etc.
- •Has had "salvage prostatectomy" - patients who failed prior therapies including external radiation therapy, cryotherapy, etc.
- •Has prior radiation therapy treatment at the site.
- •Prior hormonal therapy such as Lupron or oral anti-androgens.
- •Non-mobile, i.e. not ambulatory or bed ridden.
Outcomes
Primary Outcomes
The proportion of patients achieving return to baseline Sexual Health Inventory for Men (SHIM) score in the AmnioFix group versus the Control group.
Time Frame: 4 weeks
Secondary Outcomes
- Time to return of erectile function.(Up to 6 months)
- Pain scores.(10 days, 4 weeks, 3 months, and 6 months)
Study Sites (1)
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