Rachel Klemovitch, Assistant Editor05.09.24
Teleflex has presented new research findings from the 2024 American Urological Association Annual Meeting in San Antonio, TX. The company showcased its findings from trials using the Prostatic Urethral Lift (PUL) with the UroLift System for benign prostatic hyperplasia (BPH).
These results are from the first two randomized head-to-head trials, reinforcing the UroLift System as a leading minimally invasive surgical therapy (MIST) that can provide rapid relief and durable outcomes with preservation of sexual function [**1-5]. Patients found symptom relief and improved quality of life post-treatment.
Vice President of Global Clinical and Scientific Operations at Teleflex, Jacqueline Welch, told the press: “These significant new randomized head-to-head studies and real-world analyses demonstrate the UroLift System provides distinctive patient experience* advantages, positioning it as an early treatment option compared to medications for men whose quality of life is impacted by oppressive BPH symptoms. For over 10 years, Teleflex has advanced BPH research through numerous trials involving the UroLift system and now other contemporary treatments. Our continued investment and focus on direct comparative research helps to facilitate more informed discussions between clinicians and their patients about treatment options.”
Key findings include:
While at the Annual Meeting, Teleflex showcased the new UroLift 2 System with Advanced Tissue Control (ATC). The system recently received FDA clearance and offers, improved control of obstructive tissue, and targeting accuracy through tissue control wings and laser-etched needle markers designed to make tissue manipulation and implant delivery more precise [6].
References:
**No instances of new, sustained erectile or ejaculatory dysfunction in the L.I.F.T. pivotal study
*** While the MAUDE Database is a powerful resource, it is subject to certain limitations. These include the potential for underreporting of adverse events and the variability in the quality and consistency of the information reported. MAUDE data does not represent all known safety information for a reported medical device and should be interpreted in the context of other available information when making device-related or treatment decisions.
1. Roehrborn, et al, AUA 2024. Preliminary RCT Analysis of Minimally Invasive Surgery vs. Medication in the Initial Treatment of BPH-Associated LUTS. AUA Study sponsored by Teleflex Incorporated or its affiliates
2. Roehrborn, et al, AUA 2024. The Early Patient Experience Following Treatment With PUL and WVTT, Two Contemporary MISTs for BPH: Preliminary Results From the CLEAR Study. AUA Study sponsored by Teleflex Incorporated or its affiliates
3. Kaplan, et al, AUA 2024. A US Healthcare Claims Analysis Reveals Post-surgery Medication Use Through 5 Years Is Similar Between PUL, TURP, and GreenLight. AUA Study sponsored by Teleflex Incorporated or its affiliates
4. Kaplan, Prostate Cancer Prostatic Dis 2023
5. Shinghal R, Ashley M, Eure G, AUA 2024. Total Procedural Context is Crucial in Understanding BPH Treatment Device Safety in the FDA’s MAUDE Database. (Manuscript in preparation)
These results are from the first two randomized head-to-head trials, reinforcing the UroLift System as a leading minimally invasive surgical therapy (MIST) that can provide rapid relief and durable outcomes with preservation of sexual function [**1-5]. Patients found symptom relief and improved quality of life post-treatment.
Vice President of Global Clinical and Scientific Operations at Teleflex, Jacqueline Welch, told the press: “These significant new randomized head-to-head studies and real-world analyses demonstrate the UroLift System provides distinctive patient experience* advantages, positioning it as an early treatment option compared to medications for men whose quality of life is impacted by oppressive BPH symptoms. For over 10 years, Teleflex has advanced BPH research through numerous trials involving the UroLift system and now other contemporary treatments. Our continued investment and focus on direct comparative research helps to facilitate more informed discussions between clinicians and their patients about treatment options.”
Key findings include:
- Preliminary data suggest that PUL with the UroLift system offers better symptom relief, quality of life improvements, and patient satisfaction compared with alpha-blockers within three months following the initiation of treatment [1].
- Patients undergoing PUL with the UroLift System experienced more rapid symptom relief and quality of life improvements within the first three months post-treatment [2].
- Post-surgery medication usage analysis found that medication use was similar among the three procedures through five years [3].
- Real-world evidence serves as a litmus test for how minimally invasive and surgical therapies for BPH perform outside the highly managed settings of a clinical trial [4].
- Factoring in procedure volume, the UroLift System has the lowest rates of mild, moderate, and severe postoperative complications on a per case basis from 2019 to 2022 in the MAUDE database [***5].
While at the Annual Meeting, Teleflex showcased the new UroLift 2 System with Advanced Tissue Control (ATC). The system recently received FDA clearance and offers, improved control of obstructive tissue, and targeting accuracy through tissue control wings and laser-etched needle markers designed to make tissue manipulation and implant delivery more precise [6].
References:
**No instances of new, sustained erectile or ejaculatory dysfunction in the L.I.F.T. pivotal study
*** While the MAUDE Database is a powerful resource, it is subject to certain limitations. These include the potential for underreporting of adverse events and the variability in the quality and consistency of the information reported. MAUDE data does not represent all known safety information for a reported medical device and should be interpreted in the context of other available information when making device-related or treatment decisions.
1. Roehrborn, et al, AUA 2024. Preliminary RCT Analysis of Minimally Invasive Surgery vs. Medication in the Initial Treatment of BPH-Associated LUTS. AUA Study sponsored by Teleflex Incorporated or its affiliates
2. Roehrborn, et al, AUA 2024. The Early Patient Experience Following Treatment With PUL and WVTT, Two Contemporary MISTs for BPH: Preliminary Results From the CLEAR Study. AUA Study sponsored by Teleflex Incorporated or its affiliates
3. Kaplan, et al, AUA 2024. A US Healthcare Claims Analysis Reveals Post-surgery Medication Use Through 5 Years Is Similar Between PUL, TURP, and GreenLight. AUA Study sponsored by Teleflex Incorporated or its affiliates
4. Kaplan, Prostate Cancer Prostatic Dis 2023
5. Shinghal R, Ashley M, Eure G, AUA 2024. Total Procedural Context is Crucial in Understanding BPH Treatment Device Safety in the FDA’s MAUDE Database. (Manuscript in preparation)