The PUL procedure consists of placement of prostatic tines/suture implants along the anterolateral aspect of the prostatic urethra at the 2 and 10 o’clock positions. These tines serve as a “tie-back” on the lateral lobes of the prostate, hence widening the prostatic urethra. The implant/tines consists of a lateral nitinol capsular tab and a medial stainless steel urethral end piece joined together via a segment of non-absorbable polyethylene terephthalate (PET) suture.345 The L.I.F.T. study compared PUL to sham in 206 patients. It excluded patients with a prostate volume <30 cc, >80 cc, or those who had an obstructive median lobe. The primary outcome was IPSS improvement. The mean change from baseline IPSS at 3-month follow-up (MD: -5.2 points; 95% CI: -7.44 to -2.96) and improvement in IPSS quality of life (MD: -1.2 points; 95% CI: -1.67 to -0.73) favored PUL. The mean change in Qmax at 3 months was higher for those who underwent PUL compared to sham (4.28 mL/s versus 1.98 mL/s, respectively; P=0.005). Of the participants randomized to PUL, five-year follow-up data demonstrated slight decreases in percentage change from baseline for IPSS and quality of life scores; however, both remained significantly improved from baseline.254 A TriNetX database analysis study by Feiertag et al. showed that after a PUL procedure for BPH there was a cumulative re-procedure rate of 5.1% at 1 year, 8.2% at 2 years, 11.3% at 3 years, and 16.1% at 4 years. For the 16.1% at 4 years, PUL retreatment rate compared unfavorably to a 7.5% 4-year retreatment rate for patients who were treated with a TURP and a 7.8% 4-year retreatment rate for those treated with a PVP. Of note, it should also be mentioned that the most frequent re-procedure after a PUL was a second PUL at the one year mark, however by the fourth year, TURP was the predominant choice for re-procedure.346 Another real-world retrospective cohort study by Page et al. reported real-world outcomes from all PUL procedures conducted across National Health Service (NHS) hospitals in England with comprehensive follow-up. This PUL retrospective study cites PUL retreatment rates at 1 and 2 years that were 5.2% (95% CI: 4.2 to 6.1) and 11.9% (95% CI: 10.1 to 13.6), respectively, in contrast to the L.I.F.T. study cited above showing a 7.5% PUL retreatment rate at 2-year follow-up.347 A semi-observational study by Sheba et al. compared PUL to TURP in men with 30-100 cc prostates. In this RCT of 200 patients, it was reported that only 47.6% of patients had any improvement in IPSS after PUL (38.1% mild improvement and 9.5% good improvement; P=0.032) versus TURP patients who had a 100% improvement in IPSS after TURP (60% mild improvement and 40% good improvement; P<0.001). IPSS was found to worsen in the PUL group at 2 years by 5%, and the mean IPSS increased from 12 points at 1 year to 19 points at 2 years, with most of the worsening in IPSS occurring in PUL patients with initial poor improvement. At 3-year follow-up, the mean IPSS in the TURP group was 8 points while in the PUL group it was 23 points with significant concomitant deterioration also noted in the mean PUL Qmax rate which dropped to 9 mL/s. The reoperation rate in the third year was 0% in the TURP group and 20% in the PUL group. At 4-year follow-up, the reoperation rate was 5% in the TURP group and 40% in the PUL group (p<0.05).348 Recent evidence has supported the FDA to grant approval for PUL for prostates up to 100 cc and those with an obstructing median lobe; however, the Panel recommends this should only be considered in appropriate patients and by clinicians with sufficient procedural experience/expertise.349-351