Benefits of the prostatic urethral lift for men with lower urinary tract symptoms (LUTS) have been confirmed in a crossover study of the device, recently published in BJU International. “This study is a post hoc analysis of data from the LIFT (Luminal Improvement Following Prostatic Tissue Approximation for the Treatment of LUTS secondary to BPH) study that was published a few months ago,” explains corresponding author Henry Woo. Both studies demonstrated quick and durable improvements in symptoms and flow, as well as preservation of sexual function.
The prostatic urethral lift procedure involves permanent implantation of monofilaments that pin back the lateral prostate lobes to relieve urethral obstruction. The transurethral device used to deliver these implants is manufactured by NeoTract (USA) and marketed as the UroLift® System. The LIFT study is the first randomized controlled trial of the lift procedure versus sham (rigid cystoscopy plus mimicked surgical sounds); 206 men were recruited from 19 centres around the world.
Crossover studies are commonly used to compare the relative effects of pharmaceutical therapies, but surgical interventions and medical devices are harder to assess in this context because patients who have already undergone the intervention cannot then undergo a sham procedure. Instead, Woo and colleagues performed a one-way crossover study, whereby men who initially received the sham were later offered the lift procedure, and each patient acted as their own control.
After the primary end point (reduction in AUA International Prostate Symptom Score [IPSS] of >25% for UroLift® compared with sham) was reached, patients were unblinded and those who had undergone the sham procedure (n = 66) were offered the prostatic urethral lift procedure. 53 men agreed to receive UroLift® implants and were monitored for 12 months afterwards. Mean IPSS improvement was 122% greater after the lift procedure (11.1 points) than sham surgery (5.0 points) at 3 months, and improvements continued to 12 months, along with improvements in quality of life, BPH Impact Index and Qmax.
“We now have a number of studies that have demonstrated efficacy of the UroLift® as a treatment for LUTS, but longer term data is sought and will be the focus of future publications,” says Woo. “This study serves as an example of medical device evaluation taking on the type of rigorous data analysis that has previously only been performed in drug studies.
Cantwell, A. L. et al. Multi-center prospective crossover study of the prostatic urethral lift for the treatment of LUTS secondary to BPH. BJU Int. 10.1111/bju.12540
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Payton, S. Promising future for the prostatic urethral lift. Nat Rev Urol 10, 677 (2013). https://doi.org/10.1038/nrurol.2013.267