• John P Lenihan, Pedro Palacios, and Mariano Sotomayor.
• Tacoma Women's Specialists, Tacoma, Washington 98405, USA. jlenihan@comcast.net
• J Minim Invasive Gynecol. 2005 Sep 1;12(5):415-9.

Study ObjectiveTo demonstrate the feasibility, safety, and patient comfort associated with nonsurgical radiofrequency-energy (RF) tissue micro-remodeling in women with stress urinary incontinence (SUI) given oral and local anesthesia.DesignProspective, open-label pilot clinical trial (Canadian Task Force classification II-2).SettingDepartment of urology in a major academic teaching hospital in Mexico City, Mexico.PatientsSixteen women with SUI and hypermobility (based on history and physical examination) with no history of previous definitive incontinence therapy.InterventionsNonsurgical, transurethral, outpatient RF tissue micro-remodeling with women given oral plus local anesthesia.Measurements And Main ResultsThe women had a mean age of 49.7 years (range 30-76 years) and a mean duration of incontinence of 7.6 years (range 1-30 years). The nonsurgical RF micro-remodeling treatment, which was previously demonstrated to be of significant benefit when administered under intravenous (IV) sedation in an outpatient surgicenter 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 required for treatment completion. The first six patients received an oral sedative and oral analgesic as well as a local periurethral anesthetic block with 10 mL of 2% lidocaine. The final 10 patients (63%) received only one oral sedative or analgesic and a total of 10mL 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 one 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 zero ("no pain") to 10 ("terrible pain"). Mean score was 1.8, and 38% of subjects selected "zero."ConclusionThis pilot trial demonstrated the feasibility, safety, and patient comfort associated with performing a novel new successful technique of nonsurgical RF of the urethra for treatment of SUI, which was previously studied under IV sedation in an outpatient surgery center, on women in an office-based setting using oral plus local anesthesia.

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