Best Practices & Benign Disease
Introduction & Objective :
The Prostatic Urethral Lift (PUL) procedure for benign prostatic hyperplasia (BPH) has been proven to deliver rapid, significant, durable symptom relief with low morbidity and no sexual dysfunction. To date, the clinical evidence has been based on studies of men with lateral lobe enlargement only (LL). The objective of this study was to determine the safety and effectiveness of the PUL procedure using a new technique to treat obstructive median lobe (OML).
45 subjects were prospectively enrolled in the MedLift clinical trial (NCT02625545), an extension of the L.I.F.T. randomized study. Inclusion criteria were identical to those in the L.I.F.T. study (age ≥ 50 years, AUASI ≥ 13, peak flow rate (Qmax) ≤ 12 mL/s and prostate volume ≤ 80cc) except for requiring an OML. During the PUL procedure, small UroLift® implants were placed to retract the lateral lobes. If median lobe obstruction persisted, a modified technique using the same design UroLift® system was used to deploy implants into the median lobe to create an unobstructed anterior channel. LUTS, quality of life (QOL), Qmax and sexual function were compared to L.I.F.T. study results at 12 months.
Symptom response for OML subjects was significant and better than for LL subjects in the L.I.F.T. study (Table 1). AUASI improvement for OML subjects was at least 13.4 points at 1, 3, 6 and 12 months and significantly better than baseline at every time point (p60% and >70%, respectively at 3, 6 and 12 months). Qmax improved 90-130% throughout follow up. At 1 month, 65% subjects reported ≥ 80 on the Quality of Recovery scale, 80% reported being “much” or “very much better,” and 89% would recommend the procedure. There were no reports of de novo sustained erectile or ejaculatory dysfunction. Erectile function as measured by IIEF-5 remained stable and ejaculatory function (MSHQ-EjD score) was significantly improved throughout follow up (p< 0.001).
Patients in this study experienced excellent symptom improvement, recovery and preservation of sexual function. Obstructive median lobes can be safely and effectively treated with PUL and is supported by a new FDA median lobe indication.