Transurethral delivery of radiofrequency energy for tissue micro-remodeling in the treatment of stress urinary incontinence.

This initial human study was performed to determine the safety and quality of life impact of transurethral radiofrequency energy (RFe) tissue micro-remodeling of the proximal urethra and bladder outlet in patients with stress urinary incontinence (SUI). Forty-one patients with SUI were sequentially enrolled into four treatment groups and then underwent rapid outpatient treatment under conscious sedation using an investigational RFe delivery device. The device is passed through the urethra and palpably positioned by the anchoring of a balloon within the bladder outlet. Four small needle electrodes are deployed into the proximal urethra and/or bladder outlet submucosa, and RFe is delivered. No patient has suffered a serious adverse event in 6 months of follow-up. At 6 months, 75%-80% of patients in all four groups have demonstrated an improvement in quality of life. Two groups demonstrated statistical significance in both mean quality of life improvement and incontinence frequency reduction at 6 months.