The iTind Temporarily Implanted Nitinol Device for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Multicenter, Randomized, Controlled Trial - 24/07/21
, Dean Elterman 2, ⁎, Neal Shore 3, Marc Gittleman 4, Jay Motola 5, Sheldon Pike 6, Craig Hermann 7, William Terrens 8, Alfred Kohan 9, Ricardo R. Gonzalez 10, Aaron Katz 11, Jeffery Schiff 11, Evan Goldfischer 12, Ivan Grunberger 13, Le Mai Tu 14, Mark N. Alshak 15, Jed Kaminetzky 16Résumé |
Objective |
To report the results of a multicenter, randomized, controlled trial with a temporarily implanted nitinol device (iTind; Medi-Tate Ltd, Hadera, Israel) compared to sham for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia.
Materials and Methods |
Men 50 years or older were randomized 2:1 between iTind and sham procedure arms. A self-expanding, temporary nitinol device was placed for 5-7 days and an 18F Foley catheter was inserted and removed for the iTind and sham group, respectively. Patients were assessed at baseline, 1.5, 3, and 12 months postoperatively using the IPSS, peak urinary flow rate, residual urine, quality of life, and the International Index of Erectile Function. Unblinding occurred at 3 months.
Results |
A total of 175 men (mean age 61.1 ± 6.5) participated (118 iTind vs 57 sham). A total of 78.6% of patients in the iTind arm showed a reduction of ≥3 points in IPSS, vs 60% of patients in the control arm at 3 months. At 12 months, the iTind group reported a 9.25 decrease in IPSS (P< .0001), a 3.52ml/s increase in peak urinary flow rate (P < .0001) and a 1.9-point reduction in quality of life (P < .0001). Adverse events were typically mild and transient, most Clavien-Dindo grade I or II, in 38.1% of patients in the iTind arm and 17.5% in the control arm. No de novo ejaculatory or erectile dysfunction occurred.
Conclusion |
Treatment with the second-generation iTind provided rapid and sustained improvement in lower urinary tract symptoms for the study period while preserving sexual function.
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| Financial Disclosure of Corresponding Author: Bilal Chughtai, MD is a consultant for Medi-Tate Ltd, Olympus, Boston Scientific, and Medeon Bio. |
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| Medi-Tate Ltd. sponsored this study. |
Vol 153
P. 270-276 - juillet 2021 Retour au numéro
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