PD18-10 the itind temporarily implanted nitinol device for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia: a multicenter, randomized, controlled trial
Abstract
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 to 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 post-operatively using the IPSS, peak urinary flow rate (PFR), residual urine, quality of life (QoL), and the International Index of Erectile Function (IIEF). Unblinding occurred at 3 months.
RESULTS
A total of 175 men (mean age 61.1±6.5) participated (118 iTind vs 57 sham). 78.6% of patients in the iTind arm showed a reduction of ≥3 points in IPSS, versus 60% of patients in the control arm at 3 months. At 12 months, the iTind group reported a 9.25 decrease in IPSS (p<0.0001), a 3.52ml/s increase in PFR (p<0.0001) and a 1.9-point reduction in QoL (p<0.0001). 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.
CONCLUSIONS
Treatment with the second-generation iTind provided rapid and sustained improvement in lower urinary tract symptoms…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 175 participants or records.
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