Prostatic urethral lift for subjects in urinary retention (PULSAR): 12‐Month results of a prospective controlled trial compared with real‐world outcomes

Abstract

ObjectiveTo examine the safety and efficacy of prostatic urethral lift (PUL) in acute urinary retention (AUR) patients within a controlled (PULSAR) and real‐world setting (Real‐World Retrospective study).Materials and methodsPULSAR was a 12‐month prospective study of PUL in AUR patients (n = 51) performed at six centres in the United Kingdom; enrolled BPH patients aged ≥50 years, with prostate volume of ≤100 cc. AUR was defined as being catheter dependent with at least one prior failed trial without catheter (TWOC) while on an alpha‐blocker. RWR consisted of 3226 consecutive PUL patients across 22 international sites treated between July 2017 and March 2020; 469 of whom were in urinary retention (RWRr), that is, catheter‐dependent at the time of their procedure. Symptom response, uroflow and catheter independence rates were compared between PULSAR and RWRr subjects. A logistical regression model was constructed to evaluate patient baseline and dynamic factors predicting success after the procedure.ResultsSeventy‐three percent of PULSAR subjects were catheter independent and free from surgical reintervention at 12 months post‐PUL. Success was associated with higher voiding efficiency during the perioperative period. Slightly higher catheter‐independent rates (80%) were seen in RWRr patients; variables that influenced success included age <70 years, lower baseline prostate‐specific antigen (PSA), lower baseline post‐void residual (PVR) and shorter pre‐procedural catheter duration. Logistic regression of the combined PULSAR and RWRr retention groups revealed that procedural age <70 years and higher bladder voiding efficiency (BVE) were associated with success.ConclusionsLower baseline PSA and PVR, younger age and shorter pre‐procedure catheter durations drove successful outcomes in AUR patients undergoing PUL. Post‐PUL voiding efficiencies may help ascertain long‐term response to treatment.

Initial outcomes and surgical techniques of prostatic urethral lift for benign prostatic hyperplasia in Japan

“… 12 , 13 , 14 , 15 However, in the preoperative urinary retention group, the catheter‐free rates were reportedly 56% and 69% on postoperative days 3 and 5, respectively, and 71%–83% at 1 month postoperatively. 14 , 16 In our study, the overall catheter‐free rates were 82.0% and 92.0% on postoperative days 1 and 7, respectively, and 98.0% and 100% at 1 and 3 months postoperatively, respectively. The catheter‐free rates in the patients with preoperative nonurinary retention were 84.8% and 95.7% on postoperative days 1 and 7, respectively, and 100% at 1 month postoperatively.…”

“…This study suggests that many patients were older and had more comorbidities because of the insurance coverage of PUL in Japan; however, the initial outcomes revealed that it was safe and effective. Many reports from North America and Europe exist because they were early in introducing PUL, 12 , 13 , 14 , 15 , 16 , 17 , 18 whereas only limited reports are available from Asia, 10 as PUL was introduced a few years ago in this region. Although the number of patients in this study was small, three groups with different surgical techniques were examined.…”

“…Notably, the results of this study are comparable to those of previous studies. 12 , 13 , 14 , 15 , 16 …”