Introduction: Prostatic Urethral Lift real-world experience is consistent with controlled trial results in both non-retention and retention subjects
Methods: The Real-World Retrospective (RWR) study gathered data from 2491 subjects across 22 international sites who had undergone PUL after market clearance. RWR data was then filtered into non-retention (RWR Group A, n=2117) and retention (RWR Group B, n=374) groups. Controlled studies used for comparison were L.I.F.T. - a randomized controlled trial for PUL following non-retention subjects over 5 years (n=140), and P.U.L.S.A.R. - a controlled study following retention subjects post-PUL for 12 months (n=52). Absolute IPSS scores across all studies were compared at 1, 3, 6, and 12 months post-PUL using one-way ANOVA. Adverse events and catheterization rates of RWR subjects were calculated and compared to L.I.F.T. and P.U.L.S.A.R. studies.
Results: We report similar absolute IPSS scores among all groups at all timepoints following PUL (Figure 1), with no differences in symptom outcome after treatment between real-world and controlled studies. Analyses also revealed equivalent safety profiles when comparing real-world groups with their respective controlled studies. Adverse events in both RWR Groups (A: non-retention; B: retention) were mild-moderate, transient, and not elevated compared to L.I.F.T. or P.U.L.S.A.R. 84% of RWR Group A subjects were catheter-free post-PUL (excluding those placed for standard of care), which is slightly better than the 68% catheter-free rate of the L.I.F.T. trial. Catheter-independence of RWR Group B subjects was consistent with P.U.L.S.A.R. results at 1 month (p=0.2) and at longest available follow up (p=0.3).
Conclusions: Analysis of PUL real world study results vs. controlled trials demonstrate consistent symptom response, safety, and patient experience, revealing positive and novel findings for minimally invasive therapy in the BPH space. Source of