Sotomayor and Bernal (2003) studied the safety and quality of life impact of transurethral RF energy tissue micro-remodeling of the proximal urethra and bladder outlet in patients with SUI. Forty-one patients with SUI were sequentially enrolled into 4 treatment groups and then underwent rapid outpatient treatment under conscious sedation using an investigational RF energy delivery device. At 6 months, 75 to 80 % of patients in all 4 groups have demonstrated an improvement in quality of life. Two groups demonstrated statistical significance in both mean quality of life improvement and incontinence frequency reduction at 6 months. However, it is unclear if treatment resulted in clinically significant improvements in these parameters. Furthermore, long-term effectiveness of this approach is still unavailable.