This is a pilot proof of concept single-arm study using PuraStat following Aquablation procedure to assess reduction of hematuria to allow for same day discharge. The primary objective is to assess how PuraStat affects post-operative hematuria following Aquablation. The secondary objective is to assess the number of patients discharged on the same day based on the hematuria criteria (Grade 0 and Grade I).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
25
Sterile gel composed of synthetic peptide and sterile water; provided as a prefilled syringe. The will be applied to the inside of the prostate to help stop bleeding following Aquablation.
NYU Langone Health
New York, New York, United States
Percentage of Patients Discharged the Same Day as Aquablation
Time frame: Day 1 (Operative Visit)
Mean Post-Operation Hematuria Grade
The mean hematuria grade noticed 1-3 hours post procedure.
Time frame: Day 1 (Up to Hour 3 Post-Op)
Percentage of Patients who Experience Dysuria during Follow-Up
Time frame: Up to Week 4 Post-Operation
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