Prostatic urethral lift for subjects in urinary retention (PULSAR): 12‐Month results of a prospective controlled trial compared with real‐world outcomes
Objective To 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 methods PULSAR was a 12‐month prospective study of PUL in AUR patients (n = 51)...
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Published in | BJUI compass Vol. 5; no. 1; pp. 60 - 69 |
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Main Authors | , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
United States
John Wiley & Sons, Inc
01.01.2024
John Wiley and Sons Inc Wiley |
Subjects | |
Online Access | Get full text |
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Summary: | Objective
To 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 methods
PULSAR 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.
Results
Seventy‐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.
Conclusions
Lower 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. |
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Bibliography: | Funding information NeoTract, Inc./Teleflex sponsored this study and were involved in data collection and analysis, manuscript preparation and review. ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 content type line 23 Funding information NeoTract, Inc./Teleflex sponsored this study and were involved in data collection and analysis, manuscript preparation and review. |
ISSN: | 2688-4526 2688-4526 |
DOI: | 10.1002/bco2.280 |