Parallel Outcomes of the Prostatic Urethral Lift from Two Distinct Multicenter Real-World Studies

Sievert K1, Schonthaler M2, Eure G3, Gange S4, Chin P5, Walter P6, Grier D7

Research Type

Clinical

Abstract Category

Male Lower Urinary Tract Symptoms (LUTS) / Voiding Dysfunction

Abstract 414
Male Voiding Dysfunction and LUTS 2
Scientific Podium Short Oral Session 26
Friday 20th November 2020
16:37 - 16:45
Pavilion 9
Benign Prostatic Hyperplasia (BPH) Bladder Outlet Obstruction Male Quality of Life (QoL) Voiding Dysfunction
1. Klinikum Lippe, 2. University of Freiburg, 3. University of Virginia, 4. Granger Medical Clinic, 5. South Coast Urology, 6. NY Urology Associates, 7. Sound Urology
Presenter
K

Karl-Dietrich Sievert

Links

Abstract

Hypothesis / aims of study
Numerous clinical studies have demonstrated successful outcomes of the Prostatic Urethral Lift (PUL) for the treatment of lower urinary tract symptoms, however investigation without rigid exclusion criteria is essential to assess how the technology is performing in a real-world setting. Here we compare results from two published real-world studies of PUL: the German Multicenter Retrospective Study and the large Real-World Retrospective study.
Study design, materials and methods
The German multi-center (GM) retrospective study investigated outcomes of 86 subjects from five departments that had undergone PUL between Oct 2012 – June 2014. The Real-World Retrospective (RWR) study gathered data from 1413 subjects across 14 USA and Australian sites who had undergone PUL after market clearance. No exclusion criteria were established for baseline symptom scores, prostate size, retention history, or BPH medical therapy, as subjects needed only an IPSS before and after PUL to be enrolled. Subject baseline demographics as well as IPSS, QoL and Qmax were compared between both studies at 1, 6, 12, and 24 months after PUL.
Results
At baseline, GM subjects were younger (66 vs 70yr) and had slightly higher IPSS (20.8 vs 19) and lower Qmax (11.2 vs. 13) scores compared to RWR subjects. Past publication of these studies demonstrated similar IPSS response compared with the L.I.F.T. randomized controlled trial. Here we report parallel symptom response, QoL and uroflowmetry scores at all timepoints following PUL between the two populations (Table 1). Data was also available for 14 GM and 165 RWR subjects with a history or urinary retention, defined by as having an indwelling catheter prior to PUL. Similar rates of catheter independence were achieved by retention patients in both studies with 86% of GM and 87% of RWR subjects successfully weaned from their catheters by the last available follow-up. Common adverse events experienced by subjects in both studies included hematuria, dysuria and pelvic pain, which were mild to moderate and transient in nature.
Interpretation of results
Results from this comparative analysis utilizing two large PUL retrospective studies reveal similar effectiveness and safety outcomes for non-urinary retention and retention patients. Compared to subjects in the LIFT study, GM subjects were younger and RWR subjects were less symptomatic. In the real world, it may be that men who are earlier in their disease process seek an interventional solution.
Concluding message
These consistent results reveal that patients outside of the controlled setting of a clinical trial can be treated safely and effectively with PUL and provide information from which to make clinical evidence-based recommendations.
Figure 1
References
  1. Sievert et al (2018)
  2. Eure et al (2019)
Disclosures
Funding Neotract/Teleflex funded RWR retrospective study Clinical Trial No Subjects Human Ethics not Req'd Approved product in normal clinical setting Helsinki Yes Informed Consent No