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

Abstract

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.