Evidence indicating Prostatic Urethral Lift (PUL) delivers significant improvement in symptomatic BPH with low morbidity is based on subjects with lateral lobe (LL) enlargement only. MedLift was an FDA IDE extension of the L.I.F.T. randomized study designed to examine safety and efficacy of PUL for treatment of obstructive middle lobes (OML). Inclusion criteria for this non-randomized cohort were identical to the L.I.F.T. randomized study, except for requiring an OML: ≥ 50 years of age, IPSS ≥ 13, and Qmax ≤ 12 ml/s. Primary endpoint analysis quantified improvement in IPSS over baseline and rate of post-procedure serious complications. Quantification of symptom relief, quality of life, flow rate, and sexual function occurred through 12 months. Outcomes were compared to historical L.I.F.T LL results and were combined to demonstrate the full effectiveness of PUL. Of the 71 screened subjects, 45 were enrolled. At 1, 3, 6, and 12 months, mean IPSS improved from baseline at least 13.5 points (p < 0.0001). Quality of life and BPHII were similarly improved (>60% and >70%, respectively at 3, 6, and 12 months, p < 0.0001). Mean Qmax improvement ranged from 90 to 129% (p < 0.0001). At 1 month, 86% (CI 73–94%) reported ≥70 on the Quality of Recovery scale, 80% (CI 66–89%) reported being “much” or “very much better,” and 89% (CI 76–95%) would recommend the procedure. Compared to LL subjects, OML subjects’ symptoms improved at least as much at every time point (OML range 13.5–15.9, LL range 9.9–11.1, p ≤ 0.01). On combining OML with LL data, >70% (range CI 63–81%) of subjects demonstrated ≥ 8 point improvement in IPSS through 12 months. Analysis of the combined dataset indicates ≥ 40% (CI 30–51%) of sexually active men improved the minimal clinically important difference in erectile function through 12 months. Prostates, including those with middle lobe obstruction, can be treated with the PUL procedure safely and effectively.

Introduction: This study expands results from recent prostatic urethral lift (PUL) clinical trials by examining outcomes within a large unconstrained multicenter data set. Methods: Retrospective chart review and analysis of 1413 consecutive patients who received PUL in North America and Australia was performed. International Prostate Symptom Score (IPSS), quality of life (QoL), and maximum urinary flow rate (Qmax) were evaluated at 1, 3, 6, 12, and 24 months post-procedure for all nonurinary retention subjects (Group A) and retention subjects (Group B). Within Group A outcomes were further analyzed using paired t -tests and 95% mean confidence intervals under the following parameters: IPSS baseline ≥13, age, prostate size, site of service, prostate cancer treatment, and diabetic status. Adverse events, surgical interventions, and catheterization rates were summarized in detail. Results: Compared with the randomized controlled prosatic urethral lift (L.I.F.T.) study, subjects in this retrospective study were older and less symptomatic. After PUL, mean IPSS for Group A improved significantly from baseline by at least 8.1 points throughout follow-up. No significant differences were observed between Group A and B follow-up symptom scores. Within Group A, subjects with an IPSS baseline ≥13 behaved similarly to L.I.F.T. subjects. Age, prostate volume, site of service, prior cancer treatment, and diabetic status did not significantly affect PUL outcomes. When completed in a clinic office, PUL resulted in less side effects and catheter placement compared to other sites of service. Previous prostate cancer treatment did not elevate adverse events of high concern such as incontinence and infection. Conclusion: PUL performs well in a real-world setting in terms of symptom relief, morbidity, and patient experience for all studied patient cohorts.

This registry demonstrates the high effectiveness of all 3 approaches. The single incision sling appeared to have objective and subjective efficacy similar to that of the retropubic sling and it can be performed under local anesthesia in an office environment.

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