Risk Factors for Treatment Failure with the ATOMS Incontinence Device: Who Will Succeed, Who Will Fail? Results of a Multicenter Study

OBJECTIVE - To identify risk factors for treatment failure of men with the Adjustable Transobturator Male System (ATOMS) for treating stress urinary incontinence (SUI).

METHODS - Sixty-two patients with SUI after prostate surgery were provided with an ATOMS.

The self-defined criteria for treatment failure (implant removal [A], no improvement or ≥3 pads/24h [B] and no improvement or ≥150ml urine loss/24h [C]) were compared to anamnestic, clinical and time specific parameters: age, Charlson comorbidity index (CCI), urine culture (UC), previous ineffective implants, body mass index (BMI), radiotherapy (RT), renal function (serum creatinine), smoker status, urethral strictures (US), SUI severity, surgery time, time to and season at implantation and port system application.

RESULTS - After a median follow-up of 17. 7 months 9 ATOMS (15%) were removed due to infection (8) or dysfunction (1); 23% and 16% had treatment failure of criteria B and C. Dry-rate/overall success-rate was 61%/87%. Age alone was no risk factor but the CCI and a positive UC were univariate significant predictors of the criteria A, B and C. Besides, previous devices and renal failure were significantly associated with implant removal (A) and SUI severity with criterion C. In multivariate analysis, previous devices (p=0. 0163), positive UC (p=0. 0190) and SUI severity (p=0. 0123) were the strongest predictors of A, B and C, respectively.

CONCLUSIONS - A poor CCI, preoperative positive UC, severe SUI and previous implants lead to more treatment failure and removal. Age, BMI, RT, US, current smoking, time specific parameters, seasonality and port system application did not influence the outcome.

Urology. 2016 Jan 07 [Epub ahead of print]

Alexander Friedl, Sandra Mühlstädt, Maximilian Rom, Danijel Kivaranovic, Nasreldin Mohammed, Paolo Fornara, Clemens Brössner

Department of Urology, Hospital Göttlicher Heiland, Vienna.  Klinik and Poliklinik of Urology and Kidney Transplantation, University Hospital, Martin-Luther-University, Halle-Wittenberg, Halle/Saale. , Department of Urology, Medical University Vienna, Vienna. , Center for Medical Statistics, Informatics, and Intelligent Systems, Medical University Vienna, Vienna. , Klinik and Poliklinik of Urology and Kidney Transplantation, University Hospital, Martin-Luther-University, Halle-Wittenberg, Halle/Saale. , Klinik and Poliklinik of Urology and Kidney Transplantation, University Hospital, Martin-Luther-University, Halle-Wittenberg, Halle/Saale. , Department of Urology, Hospital Göttlicher Heiland, Vienna.

PubMed