Real-World Outcomes Demonstrate Prostatic Urethral Lift (PUL) is Safe and Effective in Non-Retention and Retention Patients
BAUS ePoster online library. Rochester M. 11/10/20; 304234; P8-8
Mr. Mark Rochester
Mr. Mark Rochester
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Abstract
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Real-World Outcomes Demonstrate Prostatic Urethral Lift (PUL) is Safe and Effective in Non-Retention and Retention Patients

Rochester M1, Eure G2, Gange S3, Barber N4
1Norfolk and Norwich University Hospital, United Kingdom, 2Urology of Virginia, USA, 3Summit Urology Group, Salt Lake City, USA, 4Frimley Park Hospital, United Kingdomr

Introduction and Objective: Real world studies reflective of heterogenous populations should serve as benchmarks for new technologies, including those within the minimally invasive field for BPH. In order to determine how the UroLift System performs in the real-world setting compared to controlled settings, analyses were performed on the large, actively enrolling Real World Retrospective (RWR) study in comparison to the LIFT pivotal and PULSAR urinary retention Prostatic Urethral Lift (PUL) trials.

Methods:
The Real-World Retrospective (RWR) study gathered data from 2491 subjects who had undergone PUL after market clearance across 22 USA, UK, and Australian sites. RWR subjects were then filtered into non-retention (RWR Group A, n=2117) and retention (RWR Group B, n=374) groups. Controlled studies used for comparison were LIFT - the 5-year randomized controlled trial for PUL in non-retention subjects (n=140), and PULSAR - a controlled study following retention subjects post-PUL for 12 months (n=52). Absolute IPSS scores were compared at 1, 3, 6, and 12 months post-procedure between all studies using a one-way ANOVA. Adverse events and catheterization rates were compared between RWR subjects and the LIFT or PULSAR study.

Results:
We observe similar absolute IPSS scores among all groups at each timepoint following PUL (Figure 1), demonstrating consistent symptom outcome after treatment between real-world and controlled studies. Analyses also revealed equivalent safety profiles between real-world groups and their respective controlled studies. Adverse events in both RWR Groups (A: non-retention; B: retention) were not elevated compared to LIFT or PULSAR and were mild-moderate and transient. 84% of RWR Group A subjects were catheter-free post-procedure when catheterization was not the standard of care, which is slightly better than the 68% catheter-free rate of the LIFT trial. Catheter-independence of RWR Group B subjects was consistent with PULSAR results at 1 month and at longest available follow up (87% RWR Group B vs. 81% PULSAR).

Conclusions:
When compared to controlled trials, PUL results from the real-world study demonstrate consistent symptom response, safety, and patient experience, revealing positive and novel findings for minimally invasive therapy in the BPH space.
Real-World Outcomes Demonstrate Prostatic Urethral Lift (PUL) is Safe and Effective in Non-Retention and Retention Patients

Rochester M1, Eure G2, Gange S3, Barber N4
1Norfolk and Norwich University Hospital, United Kingdom, 2Urology of Virginia, USA, 3Summit Urology Group, Salt Lake City, USA, 4Frimley Park Hospital, United Kingdomr

Introduction and Objective: Real world studies reflective of heterogenous populations should serve as benchmarks for new technologies, including those within the minimally invasive field for BPH. In order to determine how the UroLift System performs in the real-world setting compared to controlled settings, analyses were performed on the large, actively enrolling Real World Retrospective (RWR) study in comparison to the LIFT pivotal and PULSAR urinary retention Prostatic Urethral Lift (PUL) trials.

Methods:
The Real-World Retrospective (RWR) study gathered data from 2491 subjects who had undergone PUL after market clearance across 22 USA, UK, and Australian sites. RWR subjects were then filtered into non-retention (RWR Group A, n=2117) and retention (RWR Group B, n=374) groups. Controlled studies used for comparison were LIFT - the 5-year randomized controlled trial for PUL in non-retention subjects (n=140), and PULSAR - a controlled study following retention subjects post-PUL for 12 months (n=52). Absolute IPSS scores were compared at 1, 3, 6, and 12 months post-procedure between all studies using a one-way ANOVA. Adverse events and catheterization rates were compared between RWR subjects and the LIFT or PULSAR study.

Results:
We observe similar absolute IPSS scores among all groups at each timepoint following PUL (Figure 1), demonstrating consistent symptom outcome after treatment between real-world and controlled studies. Analyses also revealed equivalent safety profiles between real-world groups and their respective controlled studies. Adverse events in both RWR Groups (A: non-retention; B: retention) were not elevated compared to LIFT or PULSAR and were mild-moderate and transient. 84% of RWR Group A subjects were catheter-free post-procedure when catheterization was not the standard of care, which is slightly better than the 68% catheter-free rate of the LIFT trial. Catheter-independence of RWR Group B subjects was consistent with PULSAR results at 1 month and at longest available follow up (87% RWR Group B vs. 81% PULSAR).

Conclusions:
When compared to controlled trials, PUL results from the real-world study demonstrate consistent symptom response, safety, and patient experience, revealing positive and novel findings for minimally invasive therapy in the BPH space.
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