This is a prospective, randomized, single-blind, study comparing both the Viveve Treatment (RF plus cryogen) and cryogen alone treatment versus sham treatment in patients with mild to moderate stress urinary incontinence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
38
Radiofrequency and Cryogen-Cooling
Cryogen-Cooling
Sham
Milestone Research
London, Ontario, Canada
Bluewater Clinical Research Group
Sarnia, Ontario, Canada
Devonshire Clinical Research
Woodstock, Ontario, Canada
1-hour Pad Weight Test
Brief description of test: * Subject puts on one standardized, pre-weighed pad without voiding. * Subject drinks 500 mL of sodium-free liquid in \< 15 min while sitting or resting. • 15 - 45 Minutes: * Subject walks for 30 minutes, including climbing one flight of stairs (up and down). • 45 - 60 Minutes: * Subject performs the following activities Standing up from sitting (10 times) Coughing vigorously (10 times) (Subject should be standing) Running on the spot (1 min) Bending to pick up an object from the floor (5 times) • The weight of the pad is measured to determine the amount of leakage.
Time frame: Change in 1 hour Pad Weight Test Values at 5 Months from Baseline
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