This prospective, randomized, controlled clinical trial was performed to demonstrate the 12 months safety and efficacy of transurethral radiofrequency energy (RF) collagen micro‐remodeling in women with stress urinary incontinence (SUI).

Women with SUI, bladder outlet hypermobility, and leak point pressure (LPP) ≥60 cmH₂O were randomized to RF micro‐remodeling or “sham treatment.” Adverse events (AEs) were recorded. Incidence of ≥10 point incontinence quality of life (I‐QOL) score improvement, a magnitude of improvement with a demonstrated responsiveness to patient satisfaction with treatment and 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.

110 women underwent RF micro‐remodeling and 63 underwent virtually identical “sham treatment” (with the exception of RF delivery). The 12 months RF micro‐remodeling safety profile was statistically no different than that of sham treatment (a brief bladder catheterization). Seventy‐four percent of women with moderate to severe baseline SUI experienced ≥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).

Non‐surgical, 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 quality of life 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. Neurourol. Urodynam. © 2006 Wiley‐Liss, Inc.