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Clinical Results

Clinical results from over 145 peer-reviewed publications demonstrate that treatment with the UroLift™ System offers rapid and significant improvements in symptoms, urinary flow and quality of life sustained through five years.1,2

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Recovery

Rapid symptom relief and recovery1,3

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Lowest Catheter Rate

Compared to leading BPH procedures2-7

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Safe

Lowest rate of complications at one year*20

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Durable

Low surgical retreatment rate2

Consistent, Durable Outcomes

Five-year data across UroLift™ System studies demonstrate that outcomes are rapid, durable and reproducible.1,2,10

Symptom Response Is Largely Consistent Among Controlled Subjects and Real-World Retrospective Cohorts

Durability graph
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Sustained IPSS Improvement

Improvement in LUTS, as seen through average reduction in IPSS, has been largly consistent across various studies, showing rapid relief within two weeks and sustained effect through five years.1,2 Symptom relief is better than reported for medications.1,11

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Quality of Life Improvement

Significant increase in quality of life scores with 51% improvement observed at 1 year and was sustained at 50% in a 5 year study, p<0.0001.2

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Flow Rate Improvement

In addition to improving LUTS, the UroLift™ System treatment has demonstrated significant improvement in peak urinary flow rate (Qmax) of 3.5 mL/sec (44%) that was sustained to five years, p<0.0001.2

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Low Retreatment Rate

The rate of surgical intervention for failure to cure with the UroLift™ System was low for a BPH procedure, with approximately 13.6% over the five year study.1,2

Durability and Patient Experience Outcomes Across Major BPH Treatments

Chart comparing the UroLift System with Rezum, TURP, and Aquablation

FDA Guidance on Clinical Investigation of Devices for BPH

“Because loss to follow-up jeopardizes the conclusions that can be made about the long-term safety and effectiveness of a device, we recommend you limit the overall rate of loss to follow-up to less than 20% over the course of the study.” 17,§

§ Rezum and Aquablation are FDA-cleared devices

Extensive Clinical Evidence Support the UroLift™ System

For 10+ years, supported by over 145 peer-reviewed and 22 sponsored publications, the UroLift™ System has been proven to provide generally consistent outcomes between randomized clinical trials and the real world, in a large variety of prostate types, including those with obstructive median lobe and large prostates up to 100cc.18,19

Timeline of the UroLift system history
Patient listening to a doctor
“The UroLift™ System is the most well-studied minimally invasive surgical therapy for BPH. In a combined analysis from five controlled studies, we found that the majority of men who had received the procedure demonstrated measurable improvement in their BPH symptoms, flow rate, and quality of life. Subjects preserved their sexual function while some patients even experienced improvement in IIEF and MSHQ-EjD scores.”
Claus Roehrborn, MD+

References

  • 1. Roehrborn, J Urology 2013

  • 2. Roehrborn, Can J Urol 2017

  • 3. Shore, Can J Urol 2014

  • 4. Bachmann, Eur Urol 2013

  • 5. McVary, J Urol 2016

  • 6. Mollengarden, Prostate Cancer Prostatic Dis 2018

  • 7. Das, Can J Urol 2019

  • 8. AUA BPH Guidelines 2003, 2020

  • 9. McVary, Urology 2019

  • 10 Eure, J Endourol 2019

  • 11 AUA BPH Guidelines 2003

  • 12 McVary, J Urol 2021

  • 13. McVary, J Urol 2015

  • 14. Gilling, Can J Urol 2022

  • 15. Gilling, J Urol 2018

  • 16. Bachmann, Eur Urol 2016

  • 17. FDA BPH Guidance

  • 18. Eure, J Endourol 2019

  • 19. Rukstalis, Prostate Cancer Prostatic Dis 2018

  • 20. Kaplan, Prostate Cancer Prostatic Dis 2023

  • *Procedural complications were defined as complications requiring a return procedure in the outpatient setting ≥1d post-procedure.

  • + Dr. Claus Roehrborn is a paid consultant of Teleflex

MAC12000-02 Rev A