Abstract
Objective: To evaluate the safety and efficacy of radio frequency (RF) thermal treatment of the endopelvic fascia (EPF) to support the bladder neck and treat stress urinary incontinence (SUI). Methods: One hundred fourteen patients with Type I and II genuine SUI and positive valsalva leak point pressures were enrolled in this prospective, IDE study in 10 U.S. study sites. Average patient age was 49.3 ± 10.2 years, and symptom duration was 10.4 ± 8.9 years. Transvaginal incisions and reflection of the vaginal epithelial surface were used to visualize the EPF directly. Precisely controlled RF energy was applied directly to the EPF with an instrument causing it to heat and shrink. The incisions were closed using conventional techniques. Patients were assessed objectively with urodynamic testing and subjectively with incontinence questionnaires at 1, 3, 6, and 12 months postoperatively. Results: Operative time was approximately 30 minutes, and all 114 patients were treated as outpatients. There were no operative complications. Postoperatively, one patient had a urinary tract infection. Cure rates were 96/104 (92%) and 32/43 (74%) at 1 and 3 months, respectively. Conclusion: Radio frequency energy treatment to support the bladder neck and restore continence without the use of artificial materials has acceptable efficacy and low associated complications.
Published Version
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