Lenihan and colleagues (2005) examined the feasibility, safety, and patient comfort associated with RF tissue micro-remodeling in women with SUI given oral and local anesthesia. A total of 16 women with SUI and hypermobility (based on history and physical examination) with no history of previous definitive incontinence therapy were enrolled in this study. The women had a mean age of 49.7 years (range of 30 to 76 years) and a mean duration of incontinence of 7.6 years (range of 1 to 30 years). The non-surgical RF micro-remodeling treatment, which was previously shown to be of significant benefit when administered under intravenous (IV) sedation in an out-patient surgical center setting, was successfully completed in all 16 women. Either the treating physician or the patient had the option to convert to IV sedation during the procedure if there was too much discomfort; however, this did not occur in any of the 16 patients. Thus, neither the treating physician nor any patient determined that conversion to IV conscious sedation was needed for treatment completion. The first 6 patients received an oral sedative and oral analgesic as well as a local peri-urethral anesthetic block with 10-ml of 2 % lidocaine. The final 10 patients (63 %) received only 1 oral sedative or analgesic and a total of 10-ml lidocaine local anesthetic. Two women who received the maximum oral regimen (both oral sedation and analgesics) experienced nausea and emesis when drinking immediately after treatment, and 1 of these women also experienced urinary retention, which resolved after 24 hours of catheterization. Immediately before discharge, subjects classified their pain on a scale from 0 ("no pain") to 10 ("terrible pain"). Mean score was 1.8, and 38 % of subjects selected "0". The authors concluded that this pilot trial demonstrated the feasibility, safety, and patient comfort associated with performing a novel new successful technique of non-surgical RF of the urethra for the treatment of SUI in an office-based setting using oral plus local anesthesia. It should be noted that this study was not designed to evaluate the effectiveness of RF micro-remodeling in the treatment of SUI.