Editorial comment

摘要

Editorial Comment: The key words in the title of this article are "critical" and "systematic." Only patients with nonneurogenic and stress urinary incontinence undergoing primary bulbar implant of a single cuff and a 61 to 77 cm water pressure regulating balloon AMS 800? device by a surgical approach combining perineal and abdominal incisions were included. The authors report that "as a whole, the level of evidence supporting the use of [artificial urinary sphincter] for non-neurogenic [stress urinary incontinence] was low. Most of the reports were subject to methodological bias and failed to report the results accurately." Dry or improved rates were computed as 79%, apparently including all patients with 1 pad or less, and the range was from 61% to 100%. Dry rates varied from 4.3% to 85.7%. The authors state that the lack of a uniform definition of cure and the reliable use of more objective tools such as standardized pad testing prevent the true estimation of cure rate. The mean rate of erosion and infection was 8.5%, varying from 3.3% to 27.8%. In those series where urethral atrophy was "adequately reported" the mean percentage occurrence was 7.9%, varying from 1.9% to 28.6%. Mechanical failure rates varied between 2% and 13.8%, and the mean reintervention rate was 26%, varying from 14.8% to 44.8%. The review included 12 reports, comprising 623 patients with a minimum followup of 2 years. The results will be viewed as half full by some, half empty by others. For a more complete assessment of this device, and of others, the authors propose prospective studies; improved patient selection with stratification of symptoms and etiologies; contemporary definitions of "success" and appropriate methodology for measurement; utilization of only validated tools for symptoms, subjective cure, satisfaction and quality of life; prespecified definitions for early and late complications; followup beyond 5 years but in no case less than 1 year, and handling of absent data due to dropouts (utilization of intention to treat principles).