Hypothesis / aims of study
Artificial urinary sphincter (AUS) activation is usually deferred until at least 6 weeks following insertion. The rationale for this is to allow time for post-operative pain and swelling to settle. However, the benefit of delayed activation is not supported by evidence. Furthermore, there is no literature to indicate harm that might result from earlier activation. This pilot study evaluates our early experience prospectively investigating the safety and acceptability of early activation before 30 days.
Study design, materials and methods
A prospective database was established on consecutive patients undergoing AUS implantation (AMS-800 Boston Scientific) from June 2019-Feb 2021 by a single reconstructive urologist. Activation was performed by the same surgeon. Early activation was defined as less than 30 days from the date of implantation. Patients were scheduled to be seen 2 weekly from the date of implantation and assessed for early activation at each timepoint. Descriptive statistics were used to evaluate demographic and treatment-related characteristics. Continuous variables were compared using the Mann-Whitney U test.
Results
Twelve patients were included in the study cohort with a median (range) follow-up of 12 (1.12-18) months. The median (range) age was 74 years (62-81) and Charlson score was 5 (4-9). (Table 1) Indications for AUS were stress urinary incontinence following robot-assisted radical prostatectomy (RALP) alone (n= 6, 50%), RALP and external beam radiotherapy (n=5, 42%), and Holmium laser enucleation of prostate (n=1, 8%). All 12 patients were able to their AUS activated and used successfully before 30 days, with a median interval of 15 (range 13-28) days. (Figure 1) There were no adverse events of early activation at the 6-week and ongoing follow-up period. Median (range) pre-operative continence pad numbers were 4 (2-6) and 0 (0-1) at 6-weeks postoperatively. Median (range) pad weight per day was 650 (190-1100g) pre-operatively and 5.5 (5-8g) post-operatively. (Table 1)
Interpretation of results
To our knowledge, this is the first description of early activation of the AMS-800 AUS device. Our preliminary experience indicates early activation is safe and acceptable for patients given all consecutive patients underwent uneventful early AUS device. The progressive reduction in time to activation in successive cases reflects our growing confidence in early activation. All 12 patients achieved postoperative continence at the time of the last follow-up.