title: Transurethral radiofrequency energy collagen micro-remodeling for the treatment of female stress urinary incontinence.
abstract: OBJECTIVE
  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).
  
  
  METHODS
  Women with SUI, bladder outlet hypermobility, and leak point pressure (LPP) > or =60 cmH(2)O were randomized to RF micro-remodeling or "sham treatment." Adverse events (AEs) were recorded. Incidence of > or =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 > or =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.
  
  
  RESULTS
  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 > or =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).
  
  
  CONCLUSIONS
  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.
authors: Department of Urology, Baylor College of Medicine, Houston, Texas, USA.
authors: Rodney A
authors: RA
authors: Appell
authors: Saad
authors: S
authors: Juma
authors: W Glen
authors: WG
authors: Wells
authors: John P
authors: JP
authors: Lenihan
authors: Ira W
authors: IW
authors: Klimberg
authors: Angelo
authors: A
authors: Kanellos
authors: Sandra F
authors: SF
authors: Reilley