The purpose of this study is to conduct a US Pilot study of dMD-002 as a peripheral nerve repair sheet in patients with cavernous nerve injury following radical prostatectomy. The study will determine which endpoints and timepoints will be used for the pivotal study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
30
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Mean IIEF-EF scores
Time frame: 6 months postoperatively
Mean EHS score
Time frame: Screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, and 12 months
Mean SHIM score
Time frame: Screening, 3 weeks, 6 weeks, 3 months, 6 months, 9 months, and 12 months
24-hour pad weight test
Time frame: Screening, 6 weeks, and 3 months
Number of Incontinence Episodes/Day
Time frame: Screening, 6 weeks, and 3 months
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