Abstract
Objective: We report on a new method of thermal treatment of the endopelvic fascia (EPF) to lift the bladder neck and urethra without the use of implantable materials, such as sutures or mesh, to treat stress urinary incontinence using either a laparoscopic (LP) or transvaginal (TV) approach.Methods: The method of using heat to contract tissue is well documented. Two parallel, independent prospective, comparative, IDE studies were conducted. In both, precisely controlled radiofrequency energy was applied to the EPF causing it to heat and shrink. Patients were followed at 3- and 6-month intervals. Ninety-three patients (76 LP, 17 TV) have been enrolled to date.Results: Systematic measurements determined the shrinkage of the EPF was approximately 25%–50%. Success rates for LP: 78%, 80% at 3 and 6 months, TV: 90%, 90% at 3 and 6 months. Overall operative complication rates were 3% and 0% for the LP and TV, respectively. Postoperative complications were 2% and 0% for LP and TV. All complications resolved within 1 week of diagnosis with conservative management.Conclusions: Preliminary results indicate thermal treatment of the EPF for stress urinary incontinence has a high success rate and low complication rate. Further study is required, including long-term follow-up.
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