Abstract
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.
Highlights
The Prostatic Urethral Lift (PUL) procedure is a minimally invasive option for lower urinary tract symptoms (LUTS) in patients with bladder outlet obstruction (BOO)that provides significant and rapid symptom improvement with low morbidity
In accordance with the Declaration of Helsinki and federal regulations, the study was performed with approval from the institutional review boards and all men gave written informed consent (Clinicaltrials.gov: NCT02625545)
Baseline characteristics of the obstructive middle lobes (OML) subjects were similar to the characteristics of the L.I.F.T. active and control arms except the OML cohort like the control arm was younger and more symptomatic per IPSS than the lateral lobe (LL) cohort (Table 1)
Summary
The Prostatic Urethral Lift (PUL) procedure is a minimally invasive option for lower urinary tract symptoms (LUTS) in patients with bladder outlet obstruction (BOO)that provides significant and rapid symptom improvement with low morbidity. 13,474 BPH patients from a U.S medical claims database found that 61.2% of patients were not adherent to their BPH medications within the first 6 months of alpha blocker use and 66.1% discontinued within the first year [2] Surgical approaches such as transurethral resection of the prostate (TURP) and photoselective vaporization of the prostate (PVP) provide excellent symptom relief (14.0–14.9 point International Prostate Symptom Score or IPSS improvements at 1 year) but come with a risk of adverse events such as 0–8% need for blood transfusion, 2–7% rate of urethral stricture, 7–10% risk of erectile dysfunction, and 42–65% rate of ejaculatory dysfunction [1, 3, 4]. The PUL procedure has been shown to be a minimally invasive option that provides rapid, significant relief (IPSS improvement 10.8 points at 1 year) for selected subjects with lateral lobe (LL) obstruction [8,9,10,11,12,13]
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