Minimally invasive surgical therapy (MIST) for benign prostatic hyperplasia (BPH) is designed to provide effective symptom relief with minimal morbidity. Randomized controlled trials have historically served as the gold standard for demonstrating clinical safety and efficacy, yet inconsistent real-world outcomes have reduced the use of early MISTs such as TUNA and TUMT. The Prostatic Urethral Lift (PUL) is a MIST that has been shown to provide safe, rapid, and durable symptom relief with minimal morbidity for BPH patients. Here, we expand upon effectiveness results from the large, actively enrolling Real World Retrospective (RWR) study of PUL, which continues to support results from clinical studies.

2090 patients across 18 USA and Australian sites who underwent PUL following market clearance [FDA clearance Sept 2013; TGA approval Feb 2010] through May 2019 were assessed. Subjects needed a baseline IPSS score within 9 months pre-PUL and at least one IPSS score within 12 months post-PUL to be included the retrospective real-world (RWR) database. Subjects were stratified into non-retention (Group A, n=1792) and retention (Group B, n=298) groups. IPSS, QoL and Qmax were evaluated post-procedurally at 1, 3, 6, 12 & 24-months for Group A and B and absolute symptom scores compared between groups. Within Group A, outcomes were stratified for baseline prostate volume (≥80g, n=67), obstructive median lobe (OML, n=209), and prior radiation for prostate cancer (rCaP, n=62). Symptom outcomes were compared with the L.I.F.T. randomized controlled trial for PUL.

RWR subjects were an average of 70 ± 9 y.o (vs. 67 ± 7 y.o. L.I.F.T., p=<0.01). RWR mean baseline IPSS, QoL and Qmax were different from the L.I.F.T. population at 18.7 ±  7 (vs. 22.2 ± 6, p=<0.0001), 3.9 ±  2 (vs. 4.6 ± 1.1, p=<0.0001), and 12.1 ± 8 ml/s (7.9 ± 2, p=<0.0001). Group A IPSS scores improved significantly from baseline at all timepoints (p=<.0001). Group A and B had comparable IPSS symptom response across all timepoints. Subjects with large prostates experienced symptom improvement post-PUL (Figure 1) without elevated rates of post-operative adverse events. OML subjects experienced significant relief throughout follow-up (47% improvement at 3mo) with no increased rates of hematuria and dysuria compared to non-OML subjects. rCaP therapy subjects improved significantly at 1, 3 and 6 months and PSA remained unchanged throughout follow-up. No significant increases in specific adverse events (i.e. incontinence, UTI, stricture and urosepsis) were observed between CaP and non-CaP subjects.

Baseline demographics for the total RWR population reveal subjects were slightly older and less symptomatic compared with the L.I.F.T. study, however outcomes are consistent across both studies. Evidence continues to support effectiveness of PUL in populations with large prostate volumes, obstructive median lobes, and prior prostate cancer treatment at procedure. None of the populations assessed demonstrated increases in specific adverse events such as incontinence, or hematuria compared to L.I.F.T. or their real-world counterparts.

The largest real-world investigation of PUL, a MIST, continues to confirm clinical study results and demonstrates that PUL may be offered to a broad population of patient cohorts in the real world without affecting safety outcomes.