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Twelve-month results of nonsurgical radiofrequency energy micro-remodeling for stress incontinence.

Sotomayor M, Bernal GF

Department of Urology, Salvador Zubirán National Nutrition Institute, Mexico City, Mexico. pedelstein@novasysmedical.com

This pilot clinical trial was performed to evaluate the safety and impact on quality of life and incontinence episode frequency of nonsurgical radiofrequency energy (RF) tissue micro-remodeling in women with stress urinary incontinence (SUI). The palpation-guided treatment produces focal denaturation of submucosal collagen, resulting in reduced luminal wall compliance without luminal narrowing. Forty-one women suffering from SUI associated with urethral hypermobility were enrolled into four treatment groups which differed in total number and lower urinary tract location of micro-remodeling sites. No serious and only limited minor adverse events were associated with the treatment. Incidence of quality of life score improvement at 12 months ranged from 75 to 78%, and statistically significant incontinence episode frequency reduction was demonstrated by three of four treatment groups. RF micro-remodeling demonstrated 12-month safety, quality of life improvement, and incontinence episode frequency reduction. No one treatment group demonstrated clear superiority in efficacy outcomes.

Published 5 May 2005 in Int Urogynecol J Pelvic Floor Dysfunct, 16(3): 192-6; discussion 196.
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