ABOUT THIS TRIAL-
This trial (identified as PURSUIT – Prospective US Radiofrequency SUI Trial) is for premenopausal women who leak urine during certain activities, including exercising, laughing, coughing, sneezing, or other physical activities related to stress urinary incontinence (SUI).
The trial will evaluate 2 minimally invasive, single session study treatments over 12 months. The Viveve Study Treatment combines radiofrequency (RF) energy to heat the tissue layer and a placebo treatment. you have a 1 in 3 chance of receiving the placebo treatment instead of the other treatment. The placebo treatment procedure resembles the active study treatment procedure in every way but does not provide enough energy to elicit a change in the tissue.
This trial is randomized and blinded, meaning assignment to a study treatment is random and you will not know which study treatment you will receive. Regardless of which study treatment you receive, it should take less than an hour to preform.
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