iTind showed continued efficacy and safety in patients with lower urinary tract symptoms (LUTS) related to benign prostatic obstruction (BPO), according to long-term data from the MT02 study presented during the 2022 AUA Annual Meeting.1
The results, which came at a follow-up time of 50 to 79 months, demonstrated that the temporary implantable nitinol device sustained previously reported MT02 study outcomes, with iTind continuing to show a marked reduction in symptoms and improvement in quality of life and functional parameters.
“Overall IPSS and IPSS-QoL scores improved significantly for all groups vs baseline (P <.0001),” Daniele Amparore, Division of Urology, Department of Oncology, University of Turin School of Medicine, Italy, said when reporting the findings at the AUA meeting.
“Only 4% of treatment failures occurred after 3-years’ follow-up,” added Amparore.
iTind offers patients an alternative to pharmaceutical management and surgery for alleviating LUTS related to BPO. It is an in-office procedure in which urologists place the device in a folded configuration in the prostatic urethra. During the next 5 to 7 days, the device expands before urologists completely remove it.
Overall, the MT02 study enrolled 81 patients with BPO-related LUTS at 9 global locations. At initial study baseline, these patients had IPSS of 10 or higher, Qmax (peak urinary flow) less than 12 ml/sec, and a prostate volume less than 75 ml. To avoid confounders, there was a mandatory wash-out period of 6 months for 5-ARIs and 1 month for alpha-blockers.
Three (Italy, Switzerland, and Belgium) of the 9 original sites agreed to continue the study beyond 36 months. Subsequently, there were 50 patients followed-up at these sites. For their analysis, the investigators divided the patients into 3 groups based on patients’ follow-up time: 50-59 months, 60-71 months, and 72-79 months.
Overall, data were available for 42 patients with 50 to 79 months of follow-up. Of the 42 patients, 24 had a follow-up time of 50 to 59 months, 13 had a follow-up time of 60 to 71 months, and 5 had a follow-up time of 72 to 79 months. There were 4 patients lost to follow-up, 2 patients who died of causes unrelated to iTind, and 2 patients with treatment failures (1 received TURP, and the other ThuLEP). Additional medication was not required for any patients in the study.
The change in average IPSS from baseline to follow-up was -8.88±8.96, -10.31±5.07, and -9.60±6.69, for the 50-59 months, 60-to-71 months, and 72-to-79 months groups, respectively. These numeric changes translated to percent changes of -41.0%, -54.6%, and -50.3%, respectively (P <.0001 for all).
The change in average IPSS-QoL score was -2.04±1.81, -1.85±1.52, and -1.80±0.84, respectively. These numeric changes translated to percent changes of -46.8% (P <.0001), 43.8% (P <.0001), and -51.3% (P = .0015), respectively.
Regarding safety, there were no patients who had late post-operative complications.
“The results of the study are excellent. The authors appropriately selected patients—those with small non-complicated prostates. So, the question now is, how will iTind work in more complicated larger prostates? I think that remains to be seen. And a lot of times when we appropriately select patients, we can get excellent results. But then when we go out in real clinical practice and start broadening the indications, we don't get the same results. So, I'm really excited to see how iTind does in clinical practice across the globe. But the initial results presented here are quite promising,” Amy Krambeck, MD, a professor of Urology, Department of Urology, Northwestern University, Feinberg School of Medicine, said in an interview with Urology Times.
1. Amparore D, De Cillis S, Fiori C, et al. Long term follow-up of an international multicenter prospective study in application of temporary implantable nitinol device (iTind) in men with lower urinary tract symptoms for BPH. Presented during 2022 AUA Annual Meeting; New Orleans, LA. Abstract LBA01-06.