Nonsurgical transurethral radiofrequency treatment of stress urinary incontinence in women.

A transurethral radiofrequency collagen denaturation system was recently approved by the US FDA for nonsurgical, outpatient treatment of women with stress urinary incontinence associated with urethral hypermobility. Controlled radiofrequency energy applied through a transurethral probe heats submucosal tissue to produce collagen denaturation, resulting in reduced tissue compliance without necrosis, thus distinguishing this procedure from transvaginal radiofrequency tissue ablation. Treatment can be administered in 30 min under local anesthesia, without incisions, use of cystoscopy or other visualization of the treatment site. Safety and efficacy have been demonstrated in several studies, including a 12-month, multicenter, sham-procedure-controlled clinical trial in 173 women with mild-to-moderate stress urinary incontinence. In patients receiving active treatment, two of the four groups experienced significant quality-of-life changes (p = 0.004; p = 0.02), and all women exhibited significant increases in Valsalva leak point pressure (p = 0.02 vs sham group).

RCT Entities:   Population Interventions Outcomes