Radio Frequency Bladder Neck Suspension for the Treatment of GSUI Using Two Surgical Approaches

Drs. N. Kohli, B. Walton and the SURX Study Group

Harvard Medical School

Cambridge, Massachusetts

Objective:   To report the safety and efficacy of laparoscopic and transvaginal radio frequency (RF) treatment of the endopelvic fascia to support the bladder neck and treat stress urinary incontinence.

Methods: 214 patients with Type I and II genuine SUI were enrolled in this prospective, IDE study in 16 U.S. study sites. All patients were evaluated preoperatively with physical exam, subjective QOL questionnaire, and urodynamic testing. Ninety-four (44%) patients underwent a laparoscopic approach while 120 (56%) patients underwent a transvaginal approach.  Precisely controlled RF energy was directly applied to the EPF with an instrument (SURX, Inc., Pleasanton, CA) causing it to heat and shrink.  Intraoperative and postoperative complications were recorded.   Patients were assessed objectively with urodynamic testing and subjectively with incontinence questionnaires at 1, 3, 6, and 12 months postoperatively

Results: All procedures were performed under 1 hour on an outpatient basis.  There were no major device related intraoperative or postoperative complications.  3 patients (1.4%) demonstrated postoperative urinary tract infection. Cure rates at 1, 3, 6, and 12 months postoperatively were 86.8 %, 84.5%, 82.6%, and 81.2%, respectively, for the laparoscopic approach and 90.6%, 74.3%, and 72.8%, respectively, for the transvaginal approach.
Conclusion: The RF bladder neck suspension by either laparoscopic or transvaginal method appears to be a safe and effective minimally invasive approach to the surgical treatment of stress urinary incontinence.