To evaluate the safety and efficacy of the temporarily implanted nitinol device (iTind) versus prostatic urethral lift (PUL) for minimally invasive surgical treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia in a matching-adjusted indirect comparison (MAIC).
Seven clinical trials were identified via a systematic literature review. Individual patient data from iTind trials and aggregated data from PUL trials were used in the MAIC. Safety and efficacy outcomes at 12 months post-treatment were compared between the adjusted iTind population and the pooled PUL population.
iTind patients were significantly less likely than PUL patients to experience treatment-related adverse events within 3 months (25.0% vs. 79.8%; p < 0.001), including dysuria (17.8% vs. 34.7%; p = 0.001), hematuria (12.0% vs. 25.9%; p = 0.002), and pain (9.5% vs. 18.7%; p = 0.023). Rates of treatment-related adverse events from 3 to 12 months were also significantly lower among iTind than PUL patients (2.6% vs. 24.4%; p < 0.001). iTind and PUL efficacy outcomes were statistically equivalent on changes from baseline to 12 months on the International Prostate Symptom Score, quality of life, Qmax, post-void residual volume, and the Sexual Health Inventory for Men (all p > 0.05).
This MAIC found superior safety and reduced risks of early and later treatment-related adverse events with iTind versus PUL. The 12-month efficacy was equivalent on subjective and objective urinary and sexual health metrics. This study finds that the iTind temporary device provides equivalent efficacy with lower adverse event risks versus the PUL permanent implants for patients with benign prostatic hyperplasia with lower urinary tract symptoms.
The Canadian journal of urology. 2023 Oct [Epub]
Kenneth M Kernen, Shalina Omar, Bradley Goodnight, Paul Skodny, Stuart Bruce, Tiffany M Yu
Michigan Institute of Urology, Troy, Michigan, USA., Guidehouse Inc., San Francisco, California, USA., Olympus Corporation of the Americas, Center Valley, Pennsylvania, USA.