Presentation Authors: Daniel Rukstalis*, Winston Salem, NC, Douglas Grier, Edmonds, WA, Sean Stroup, San Diego, CA, Ronald Tutrone, Towson, MD, Euclid deSouza, Omaha, NE, Sheldon Freedman, Las Vegas, CA, Richard David, Sherman Oaks, CA, Jed Kamientsky, New York, NY, Gregg Eure, Virginia Beach, VA
Introduction: The evidence showing that the Prostatic Urethral Lift (PUL) delivers excellent results with low morbidity has been based on studies of men with lateral lobe enlargement only (LL). The MedLift trial was undertaken as an FDA extension of the L.I.F.T. randomized study to determine the safety and effectiveness of PUL for obstructive middle lobe (OML). The results were combined with those from the L.I.F.T. study to understand the effect of PUL across all types of prostate enlargement as would be seen in the clinical setting.
Methods: Inclusion criteria for OML patients were the same as those from the L.I.F.T. study except for requiring OML: age â‰¥ 50, International Prostate Symptom Score (IPSS) â‰¥ 13, peak flow rate (Qmax) â‰¤ 12 ml/s and prostate volume 30-80cc. Symptom relief, quality of life (QoL), BPH Impact Index, Qmax, sexual function, and adverse events were evaluated through 12 months for OML patients. An analysis of the combined L.I.F.T. LL only with MedLift OML cohorts was conducted on symptom response and sexual function.
Results: When combining OML with LL patients, the combined cohort responded with â‰¥ 11 point IPSS, â‰¥ 2.3 point QoL, and â‰¥ 70% Qmax improvement at 1, 3, 6 and 12 months. Further, >70% of combined cohort subjects experienced IPSS improvement â‰¥ 8 points through 12 months. In sexually active men, 45% of men (35/78) improved the minimal clinically important difference (MCID) in erectile function as measured by IIEF-EF at 3 months and 40% (31/77) achieved the threshold at 12 months (Table 1) MSHQ- EjD function and bother for the combination cohort were significantly improved by at least 30% from baseline at all timepoints (p-values ranged between 0.01 and < .0001).
Conclusions: Patients with all types of prostate enlargement, including OML, experience excellent symptom improvement with low morbidity and preservation of sexual function. When combining the OML data with lateral lobe only patients, results indicate that many men may experience substantial, important improvement both in symptoms as well as erectile function after PUL. These results provide more representative outcomes when looking at the broader BPH population and may inspire discussion with patients when considering different treatment options.
Source of Funding: Neotract/Teleflex Inc.