Appell and co-workers (2006) performed a prospective, randomized, controlled trial to demonstrate the 12 months safety and effectiveness of transurethral RF collagen micro-remodeling in women with SUI. Women with SUI, bladder outlet hypermobility, and leak point pressure (LPP) greater than or equal to 60 cm H(2)O were randomized to RF micro-remodeling or "sham treatment". Adverse events (AEs) were recorded. Incidence of greater than or equal to 10-point I-QOL score improvement, a magnitude of improvement with a demonstrated responsiveness to patient satisfaction with treatment and to greater than or equal to 25 % reduction in both incontinence episode frequency and stress pad weight, served as a subjective outcome measurement. Change in mean LPP served as an objective outcome measurement. The 12-month RF micro-remodeling safety profile was statistically no different than that of sham treatment (a brief bladder catheterization). Seventy-four % of women with moderate-to-severe baseline SUI experienced greater than or equal to 10-point I-QOL score improvement at 12 months (p = 0.04). Women who underwent RF micro-remodeling demonstrated LPP elevation at 12 months, while sham-treated women demonstrated LPP reduction (p = 0.02). The authors concluded that transurethral RF micro-remodeling is a safe treatment for women with SUI. In women with moderate-to-severe SUI, this novel therapy resulted in statistically significant improvement in QOL of a magnitude associated with patient satisfaction with the treatment. Women who underwent RF micro-remodeling demonstrated a statistically significant elevation in mean LPP at 12 months. While this study found statistically significant improvement in frequency and severity of incontinence episodes, the criterion of greater than or equal to 25 % reduction in both incontinence episode frequency and stress pad weight seems to be a "low bar" to clear. While RF micro-remodeling demonstrated a statistically significant elevation in mean LPP at 12 months; its clinical relevance is unclear. It is also interesting that the authors concluded that "transurethral RF micro-remodeling is a safe treatment for women with SUI" (effectiveness was not addressed). Furthermore, this study appeared to have the same group of subjects as reported by Lenihan (2005) -- 110 women underwent RF micro-remodeling and 63 underwent virtually identical "sham treatment".