Histologic results of a new treatment for stress urinary incontinence without implantable materials

Abstract

Objective: Collagen in tissue such as endopelvic fascia shrinks when heated. A new method to treat stress urinary incontinence using collagen shrinkage to lift the urethra and bladder neck without the use of implantable materials has shown promising efficacy. This study reports histologic findings from animal and IDE clinical trials after thermal treatment.Methods: Tests on animal that the fascia were conducted using a probe to deliver radiofrequency energy. Animal samples were histologically evaluated to determine strength at 0, 7, 21, and 42 days posttreatment. Also, tissue samples from two patients who had thermal urethroplasty were analyzed 6 months posttreatment.Results: Animal tests showed fascia shrinks upon thermal treatment and does not restretch during the healing time of 42 days. Tissue strength followed previously published healing curves for electrocautery treatments. Systematic treatment methodology showed tissue shrinkage ranged from 25% to 50%. Histologic samples at 6-month patient follow-up showed normal tissue had regenerated. No adhesions were observed.Conclusions: Shrinkage of endopelvic fascia using radiofrequency energy results in normal collagen formation and healing very similar to published data. This treatment holds promise for the successful treatment of stress urinary incontinence without implantable materials.