October 26, 2022 – Teleflex announced new data published in the peer-reviewed Journal of Endourology demonstrate the minimally invasive Prostatic Urethral Lift (PUL) procedure using the UroLift® System yields consistent safety, effectiveness and patient experience outcomes for benign prostatic hyperplasia (BPH) with and without obstructive median lobes.
The comparative analysis, “Prostatic Urethral Lift for Obstructive Median Lobes: Consistent Results Across Controlled Trial and Real-World Settings,” is the first to assess the UroLift® System in both clinical settings and compare safety, symptom, and patient experience outcomes to transurethral resection of the prostate (TURP) and sham treatments in controlled settings.
Controlled clinical trial results of the UroLift® System for obstructive median lobes reveal that men who underwent PUL experienced better symptom improvement within the first three months of treatment compared to those treated with sham and TURP in other controlled studies, and did not endure high grade serious adverse events. Ejaculatory function scores for men treated with the UroLift® System were also significantly better than TURP at all timepoints.
PUL for obstructive median lobes in a real-world setting confirms controlled clinical trial results following treatment with the UroLift® System. Symptom and uroflow outcomes were largely consistent for obstructive median lobe patients treated in controlled and real-world settings; however, patients treated in a real-world setting experienced fewer post-operative catheterizations without elevated adverse events. Furthermore, real-world safety, symptom and patient experience outcomes were equivalent between men with lateral and median lobe obstruction.
The comparative analysis included patients across 3 controlled clinical studies, including the 5 year L.I.F.T. Trial and MedLift, an FDA-approved IDE extension of L.I.F.T., and 1 real world retrospective study. Specifically, outcomes of obstructive median lobe patients treated with the UroLift® System in controlled (the MedLift study, n=45) and real-world settings (i.e., the real-world retrospective study of the UroLift® System, n=180) were evaluated against comparator groups (subjects without obstructive median lobe treated with TURP [n=35] and sham [n=66] in randomized controlled trials) to assess consistency in safety, symptom response and patient experience. The L.I.F.T. study has proven UroLift® System durability out to 5 years with a surgical retreatment rate of 13.6% over 5 years or about 2-3% per year.
Key findings of the comparative analysis include:
- UroLift ® System vs sham: Subjects in the MedLift study experienced 170% greater symptom improvement at three months post-procedure to sham subjects in the L.I.F.T. study.
- UroLift ® System vs TURP: Subjects in the MedLift study had significantly greater improvement (i.e., IPSS point change from baseline) at one and three months, and similar improvement at six and 12 months to TURP subjects in the BPH6 trial. Significantly more MedLift subjects were satisfied sooner after treatment (one and three months), while a similar rate of patient satisfaction was observed between MedLift and TURP subjects at six and 12 months post-treatment. Ejaculatory function and bother scores were significantly better for MedLift subjects at all time points.
- Controlled vs real-world outcomes: Symptom improvement was equivalent among MedLift study subjects and the filtered real-world obstructive median lobe group at three, six, and 12 months post-treatment.