Effectiveness of Adjustable Transobturator Male System (ATOMS) to Treat Male Stress Incontinence: A Systematic Review and Meta-Analysis

Abstract

Introduction Adjustable transobturator male system (ATOMS) is a surgical device developed to treat male stress urinary incontinence (SUI) after prostate surgery. The objective was to assess the effectiveness of the ATOMS device to treat male SUI as described in the literature.

Methods Two independent reviewers identified studies eligible for a systematic review and meta-analysis of various sources written in English, German and Spanish, using the databases PubMed, EMBASE and Web of Science. We excluded studies on female incontinence. We employed the DerSimonian and Laird method for defining heterogeneity, calculating the grouped standard mean deviation (SMD). The primary objective of this review is the assessment of clinical efficacy based on the achievement of dryness after device adjustment, defined as use of no pad or one safety pad per day (PPD). The secondary objective was focused on analysing improvement of incontinence with the device. Magnitude of effect was calculated by analysing decrease in pad count (PPD) and/or in 24-h pad test. Number and severity of complications according to Clavien–Dindo classification were also reviewed.

Results The pooled data of 1393 patients from 20 studies (13 retrospective and 7 prospective) showed that treatment with ATOMS resulted in a mean 67% dryness rate and 90% improvement after adjustment. Mean total number of system fillings per patient was 2.4. Mean pad count and 24-h pad test decrease were − 4.14 PPD and − 443 cc, respectively. There is significant heterogeneity of the sample analysed, mainly based on variable baseline severity of incontinence, proportion of patients treated with irradiation and different generation devices. Proportion of irradiated patients affected dryness rate (p = 0.0014), together with baseline severity of incontinence (p = 0.0035) and different generation device used (p < 0.0001). Standardized mean follow-up was 20.9 months, with complications occurring in 16.4% (major complications 3.0%) and explantations in 5.75%. No randomized study has been developed so far to compare ATOMS to other devices for treating male SUI.

Conclusion Despite the evidence being exclusively based on descriptive studies and limited follow-up, ATOMS has proven to be a safe alternative to treat different degrees of male SUI after prostate surgery. Better results are evidenced for patients with less than 6 PPD before implantation, non-irradiated patients and use of third-generation device with silicone-covered pre-attached scrotal port.