Presentation Authors: Mark Rochester*, Norwich, United Kingdom, Toby Page, Newcastle, United Kingdom, Neil Barber, Frimley, United Kingdom, Oliver Kayes, Leeds, United Kingdom
Introduction: Acute urinary retention (AUR) patients nonresponsive to alpha blockade have limited treatment options to restore voiding and have been commonly excluded from clinical trials examining efficacy of minimally invasive technology. This study assessed feasibility of the Prostatic Urethra Lift (PUL) in patients with AUR secondary to benign prostate obstruction.
Methods: AUR male subjects (â‰¥ 50 years of age) diagnosed with symptomatic BPH and at least one failed trial without catheter (TWOC) while on alpha blocker were enrolled in the study. Subjects with retention volumes >1500mL were excluded. Void trials were performed 3 days post-procedure, and symptom response (IPSS), quality of life (QoL), BPH Impact Index (BPHII), peak flow rate (Qmax) and post void residual (PVR) were assessed at 6-week follow-up. Percent of successful first TWOC and time to catheter independence was calculated. Incidence of related adverse events and surgical interventions were analyzed and summarized descriptively.
Results: This preliminary analysis included 30 males (mean age of 73 years) who received PUL across 4 sites in the United Kingdom. Mean prostate volume at baseline was 56.9cc and mean duration of the most recent retention episode prior to PUL was 83.4 days. Furthermore, 66.7% of subjects failed two or more TWOCs before the procedure. Although baseline symptom response and uroflowmetry assessments were not available due to retention status, mean IPSS (9.7), QoL (1.3), BPHII (1.8) and Qmax (8.7ml/s) and PVR (112.1ml) were recorded at 6-week follow-up (Table 1). Compared to L.I.F.T 3-month unpaired outcomes, AUR subjects demonstrated similar IPSS, BPHII and PVR, but lower QoL and lower Qmax scores (Table 1, p < 0.05). 63.3% of AUR subjects were able to void without a catheter and 70% were catheter free by 1 month. The majority of adverse events were mild to moderate and resolved by two weeks. One subject experienced a UTI and two subjects experienced hematuria events that were serious but resolved by two weeks. One subject underwent a HoLEP 114 days post-procedure.
Conclusions: PUL offers AUR patients an alternative to long-term catheter management and invasive treatment options. This approach can quickly and safely restore spontaneous micturition in this patient population.
Source of Funding: Neotract/Teleflex Inc.