Initial experience and results with a new adjustable transobturator male system for the treatment of stress urinary incontinence.

Abstract

We report on our initial experience in terms of efficacy and safety with a new, self-anchoring adjustable transobturator male system (A.M.I.® ATOMS System) for the treatment of male stress urinary incontinence after prostate surgery. In this prospective, nonrandomized single center study conducted between March and December 2009, patients with stress urinary incontinence secondary to prostatic surgery were treated with the ATOMS device. Urethroscopy, filling and voiding cystometry were performed preoperatively for all patients. In addition, incontinence symptoms were assessed, and a physical examination, 24-hour pad test and 24-hour pad count were performed before and after surgery. A total of 38 patients were included in the study (36 after radical prostatectomy, 2 after benign prostatic hyperplasia surgery). No intraoperative complications occurred. Mean number of adjustments during followup was 3.97 (range 0 to 9). At a mean followup of 16.9 months (range 13 to 21) the overall success rate was 84.2%. Of the successful cases 60.5% were considered dry (0 to 1 pad and less than 15 ml/24-hour pad test) and 23.7% improved (more than 1 pad per 24 hours but more than 50% decrease in pad use and less than 100 ml per 24-hour pad test). In 15.8% of the patients the treatment was considered to have failed (more than 2 pads daily and greater than 100 ml on 24-hour pad test). The treatment of male stress urinary incontinence with the ATOMS is safe and effective. It is an excellent first or second line treatment for mild to moderate male stress urinary incontinence, even after external irradiation. The option of long-term, minimally invasive adjustment to respond to patient needs is a significant advantage of this new implant.