iTind device shows durable safety and efficacy in patients with BPH-related LUTS

Patients who received treatment with the iTind device for lower urinary tract symptoms (LUTS) related to benign prostatic hyperplasia (BPH) showed a significant and durable reduction in symptoms and improved quality of life (QoL) for more than 48 months following treatment, according to findings from the MT02 study (NCT02145208) published in Minerva Urology Nephrology.¹

In total, 41 patients were followed for 50 to 79 months following treatment with an average follow-up time of 60.2 months.

“This evidence of clinical durability is important to physicians considering surgical options for BPH symptom treatment. We now have published study data showing iTind device treatment is a reliable minimally invasive surgical option with minimal safety concerns for extended time periods,” said co-lead author, Daniele Amparore, MD, in a news release on the findings.² Amparore is a researcher at San Luigi Gonzaga University Hospital in Orbassano, Italy.

The prospective, single-arm, multicenter study enrolled a total of 81 patients from December 2014 to December 2016. Inclusion criteria consisted of an International Prostate Symptom Score (IPSS) of 10 or greater, a maximum flow rate of less than 12, and a prostate volume of less than 75 mL. At 36 months, data were available for 50 patients who pursued continued participation.

Among those, 5 patients were lost to follow-up, 2 patients died unrelated to device placement, and 2 patients required surgical retreatments at 48-month follow-up. Thus, 41 patients were followed for 50 to 79 months following treatment with an average follow-up time of 60.2 months. Patients included in this group spanned across 3 of 9 international sites (Italy, Switzerland, and Belgium) included in the study.

Data among patients with follow-up of greater than 48 months showed a durable improvement in patient symptoms, with an IPSS reduction of 45.2% from baseline to 79 months following treatment (P < .0001). The average IPSS score was 11.26 (standard deviation = 7.67) among all patients. Similarly, data showed an IPSS-QoL reduction of 45.1% among all patients over the same time period (P < .0001), with an average score of 2.10 among all those included in the study (standard deviation = 1.41).

There were no post-operative complications reported from 36 to 79 months, and no patients required additional medication. Only 4% of patients required surgical retreatment after 36 months. In total, 11.1% of patients from the original study cohort required surgical retreatment from baseline to 79 months.

The authors concluded, “The long-term follow-up data reported in this study has provided evidence that the iTind device implant demonstrates clinical durability and may be considered a reliable surgical modality for the relief of BPH-related LUTS, even in the setting of ‘bridge treatment.’”

References

1. Amparore D, De Cillis S, Schulman C, Kadner G, Fiori C, Porpiglia F. Temporary implantable nitinol device for benign prostatic hyperplasia-related lower urinary tract symptoms: over 48-month results. Minerva Urol Nephrol. Published online June 23, 2023. doi:10.23736/S2724-6051.23.05322-3

2. Study proves iTind treatment for enlarged prostate lasts more than four years. News release. Olympus Corporation. July 12, 2023. Accessed July 19, 2023. https://www.olympus-europa.com/company/en/news/press-releases/2023-07-12t12-00-00/study-proves-itind-treatment-for-enlarged-prostate-lasts-more-than-four-years.html