Urethral lift is superior to medical therapy in efficacy, patient experience

The prostatic urethral lift (PUL, UroLift) was found to be superior to medical therapy with tamsulosin (Flomax) in the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH), it was reported at the 2024 American Urological Association Annual Meeting in San Antonio, Texas.¹

Claus G. Roehrborn, MD

Findings from the IMPACT randomized controlled trial (NCT04987892) were presented by Claus G. Roehrborn, MD, the E.E. Fogelson and Greer Garson Fogelson Distinguished Chair in Urology and S.T. Harris Family Chair in Medical Science, in Honor of John D. McConnell, MD, at the UT Southwestern Medical Center in Dallas, Texas. In his presentation slides, Roehrborn noted that IMPACT “is the largest head-to-head open-label [randomized controlled trial] comparing efficacy, safety, and patient experience after a [minimally invasive surgical] intervention for LUTS/BPH and medical therapy.”

A total of 88 patients who underwent PUL placement and 112 patients receiving medication were available for the preliminary analysis, Roehrborn reported. The primary end point was change in BPH symptoms at 3 months as measured by International Prostate Symptom Score (IPSS). Secondary end points included quality of life, satisfaction with treatment, treatment goal achievement, and adverse events (AEs).

Patients were eligible for the study if they were 45 years of age or older, had a diagnosis of BPH, experienced symptoms of BPH as indicated by an IPSS of 30 or lower, no urinary flow rate threshold, willingness to wash out of current BPH medication(s), an appropriate candidate for both BPH therapies used in the study, ability to understand and consent to participate in the study, and willingness and ability to participate in follow-up evaluations.

Patients receiving PUL experienced improvements of 8.6 and (39.1%) and 10 (46.8%) in IPSS total score, whereas patients receiving tamsulosin saw improvements of 3.4 (16.9%) and 3.1 (14.2%) in IPSS total score. Maximum flow rate (Qmax) increased by 3.8 mL/s (15.0 mL/s to 18.8 mL/s) in patients receiving PUL and by 0.9 mL/s (15.2 mL/s to 16.1 mL/s) in patients receiving tamsulosin.

Regarding quality of life, scores improved by 2.0 (39.3%) and 2.2 (47.9%) in the PUL group and 0.6 (10.2%) and 0.5 (7.8%) for the tamsulosin group at 1 and 3 months. Patients receiving PUL saw improvements of 2.9 (41%) and 4.5 (63%) in BPH Impact Index vs 1.8 (26%) and 1.8 (25%) for patients receiving tamsulosin at 1 and 3 months.

The investigators administered the Patient Perception of Study Medication (PPSM) questionnaire, which includes 7 questions assessing patient satisfaction with treatment used in the CombAT trial. The total scores ranged from 7 to 49; higher scores are associated with worse experience, and a greater decrease is associated with greater improvement. Roehrborn reported that PPSM scores were more positive following PUL, with an improved perception of 11% at 3 months compared with worsened perception of 4% for tamsulosin.

The King’s Health Questionnaire was also administered to patients, which measures physical and social improvement, relationship improvement, and emotional improvement. “PUL subjects reported greater physical/social, relationship, and emotional improvements compared to tamsulosin,” the investigators reported.

Also administered for the study was the Self-Assessment Goal Achievement questionnaire. For the question “Overall, to what extent have you achieved your goals?” using a scale in which 0 represented “did not achieve my goals at all” and 4 represented “exceeded my goals,” overall goal achievement was 1.8 at 1 month for the PUL group vs 1.2 for the tamsulosin group, and 2 at 3 months for the PUL group vs 1.1 for the tamsulosin group.

Early data from the study indicated that 55.6% of patients in the PUL group encountered at least 1 AE compared with 17.8% of patients in the tamsulosin group. “Of adjudicated…PUL AEs for which duration is available, most resolved within 2 weeks,” wrote the investigators. Longer durations of AEs were observed in the tamsulosin group.

REFERENCE

1. Roehrborn CG. Paradigm-shifting, practice-changing clinical trials in urology: preliminary RCT Analysis of Minimally Invasive Surgery vs. Medication in the Initial Treatment of BPH-Associated LUTS. Presented at 2024 American Urological Association Annual Meeting. May 3-6, 2024, San Antonio, Texas