The Spanner is being evaluated for use to manage voiding dysfunction and lower urinary tract symptoms in subjects to achieve bladder drainage in men unfit for other treatments.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
107
Atlantic Urology
Daytona Beach, Florida, United States
Advanced Urology Specialists
Oxford, Florida, United States
Urology Specialists of West Florida
Palm Harbor, Florida, United States
Pinellas Urology Inc
South Pasadena, Florida, United States
Number of Participants Who Achieved Post-void Residual (PVR) of ≤150 ml Over 90 Days
To determine the percentage of subjects who achieved adequate bladder drainage over 90 days, defined as a PVR of ≤150 ml.
Time frame: 90 days
Number of Participants Who Achieved Post-void Residual (PVR) of ≤150 ml Over 30 Days
To determine the percentage of subjects who achieved adequate bladder drainage over 30 days, defined as a PVR of ≤150 ml.
Time frame: 30 days
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Greater Boston Urology
Hingham, Massachusetts, United States
Brooklyn Urology Research Group
Brooklyn, New York, United States