Transvaginal Radio Frequency Treatment of the Endopelvic Fascia: A Prospective Evaluation for the Treatment of Genuine Stress Urinary Incontinence

Abstract

We evaluate the safety and efficacy of a new treatment modality for genuine stress urinary incontinence which was a transvaginal radio frequency applicator to deliver radio frequency energy to the endopelvic fascia. The purported mechanism of effect for this therapy is shrinkage of the collagenated tissue which composes the endopelvic fascia that supports the bladder neck and proximal urethra, thus stabilizing the proximal urethra and bladder neck. In prior animal trials and early pilot studies this therapy was shown to cause a reproducible thermal effect manifested by fascial shrinkage. Preliminary human trials indicated a therapeutic benefit of this therapy for women with genuine stress urinary incontinence. To our knowledge this is the first multicenter study of a transvaginal approach for radio frequency of the endopelvic fascia for treatment of genuine stress incontinence. Between June 1999 and June 2000, 120 consecutive women (mean age 49.9 years) at 10 sites underwent transvaginal radio frequency treatment in a prospective trial to evaluate the overall efficacy and safety profile of this therapy. All patients had preoperative urethral hypermobility (average cotton swab change 38 degrees). Detrusor instability was excluded by cystometry. In all procedures precisely controlled radio frequency energy was applied to the endopelvic fascia to heat and shrink the tissue. The patients were evaluated postoperatively at 1 week and at 1, 3, 6 and 12 months using objective and subjective measures. Primary end points consisted of physician assessment of continence, patient reported pad use and the number of patient reported episodes. Safety was determined for acute (immediate postoperative) and chronic time frames. Of the 120 patients 96 completed 1-year evaluation. Average operative time was less than 30 minutes, and all patients were treated as outpatients. Preoperatively 101 patients (84%) averaged 1 or more episodes of urinary incontinence per day. At 3, 6 and 12 months 57%, 66% and 59% of patients, respectively, averaged 1 or no daily episodes of urinary incontinence. At 12-month followup 79 of 109 patients (73%) reported being continent or improved. Preoperatively, 43% of patients reported using 1 or no pads daily. At 3, 6 and 12 months 69%, 70% and 72% of patients, respectively, required 1 or no pads daily. On urodynamic evaluation at 12-month followup 76.0% of the patients did not leak with a Valsalva maneuver. A total of 30 cases were classified as failures and 11 women were lost to followup. There were no intraoperative complications, 3 (4%) minor postoperative complications which resolved, and no device related complications. The transvaginal radio frequency applicator demonstrated good efficacy and excellent safety at 1-year followup. Ongoing analysis of the data has indicated opportunities for improvement of this new surgical technique that could result in higher efficacy rates without compromising safety. Further long-term evaluation is being conducted to assess chronic durability of the procedure.