title: 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.
authors.affiliation: Department of Urology, Salvador Zubirán National Nutrition Institute, Mexico City, Mexico. pedelstein@novasysmedical.com
authors.forename: Mariano
authors.initials: M
authors.lastname: Sotomayor
authors.forename: Guillermo Feria
authors.initials: GF
authors.lastname: Bernal
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003094:Collagen; D005260:Female; D006801:Humans; D008875:Middle Aged; D017060:Patient Satisfaction; D011788:Quality of Life; D000078702:Radiofrequency Therapy; D013696:Temperature; D016896:Treatment Outcome; D014550:Urinary Incontinence, Stress / Q000628:therapy*
chemical_list: D003094:Collagen