Background: This study (MT02) reports >48-month (50-79 months) results of a prospective, single-arm, multicenter study (NCT02145208) of temporary implantable nitinol device (iTind (R)) in men with benign prostatic hyperplasia (BPH)-related lower urinary tract symptoms (LUTS). Methods: Men with symptomatic BPH (International Prostate Symptom Score [IPSS] >= 10, Maximum flow rate [Qmax] <12 mL/s, and prostate volume <75 mL) from 9 centers were enrolled from December 2014 to December 2016. Total 50/81 (62%) patients at 3/9 sites (Italy, Switzerland, and Belgium), pursued the study beyond 36 months following iTind (R) device, per study protocol. Due to COVID-19, follow-up was amended. Each patient was assessed once during 50-79 months postoperatively for IPSS and IPSS-quality of life (IPSS-QoL), change in medication, need for surgical re-treatment and adverse events telephonically. Results: Post 36 month-follow-up, 5 patients were lost to follow-up and 2 patients died unrelated to iTind (R) device placement. Two patients (36-48 months follow-up) required surgical re-treatments (1 transurethral resection of prostate, 1 Thulium laser enucleation of prostate). >48 months results were available for 41 patients wherein iTind (R) device treatment showed significant improvement in symptoms (IPSS: -45.3%, P<0.0001 and IPSS-QoL: -45.1%, P<0.0001) from baseline to 79 months post-procedure; mean +/- SD of 11.26 +/- 7.67 and 2.10 +/- 1.41 points, respectively. No complications were recorded between 36 up to 79 months; no patient required additional medication. Conclusions: iTind (R) device provided significant and durable symptom reduction and improved IPSS-QoL for >48 months post treatment. No late postoperative complications were reported beyond 36 months of follow-up. Surgical re-treatment rate for >36 months was 4%.
Temporary implantable nitinol device for benign prostatic hyperplasia-related lower urinary tract symptoms: over 48-month results
AMPARORE, Daniele;De CILLIS, Sabrina;FIORI, Cristian;PORPIGLIA, Francesco
2023-01-01
Abstract
Background: This study (MT02) reports >48-month (50-79 months) results of a prospective, single-arm, multicenter study (NCT02145208) of temporary implantable nitinol device (iTind (R)) in men with benign prostatic hyperplasia (BPH)-related lower urinary tract symptoms (LUTS). Methods: Men with symptomatic BPH (International Prostate Symptom Score [IPSS] >= 10, Maximum flow rate [Qmax] <12 mL/s, and prostate volume <75 mL) from 9 centers were enrolled from December 2014 to December 2016. Total 50/81 (62%) patients at 3/9 sites (Italy, Switzerland, and Belgium), pursued the study beyond 36 months following iTind (R) device, per study protocol. Due to COVID-19, follow-up was amended. Each patient was assessed once during 50-79 months postoperatively for IPSS and IPSS-quality of life (IPSS-QoL), change in medication, need for surgical re-treatment and adverse events telephonically. Results: Post 36 month-follow-up, 5 patients were lost to follow-up and 2 patients died unrelated to iTind (R) device placement. Two patients (36-48 months follow-up) required surgical re-treatments (1 transurethral resection of prostate, 1 Thulium laser enucleation of prostate). >48 months results were available for 41 patients wherein iTind (R) device treatment showed significant improvement in symptoms (IPSS: -45.3%, P<0.0001 and IPSS-QoL: -45.1%, P<0.0001) from baseline to 79 months post-procedure; mean +/- SD of 11.26 +/- 7.67 and 2.10 +/- 1.41 points, respectively. No complications were recorded between 36 up to 79 months; no patient required additional medication. Conclusions: iTind (R) device provided significant and durable symptom reduction and improved IPSS-QoL for >48 months post treatment. No late postoperative complications were reported beyond 36 months of follow-up. Surgical re-treatment rate for >36 months was 4%.
I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
