To evaluate the functional outcomes as they relate to the preservation of urinary continence and sexual function after treatment with the temporarily implanted nitinol device (iTind; Medi-Tate Ltd, Israel); a novel minimally invasive treatment for lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).
Men with symptomatic BPH (IPSS ≥ 10, Qmax < 12 ml/s, and prostate volume (PV) < 120 ml) were invited to participate in this single-arm, prospective multicenter study (MT06). Patients were not washed out of BPH medications before the procedure. The iTind was implanted through a 22F rigid cystoscope under intravenous sedation and was removed 5-7 days later through a 22F Foley catheter under local anesthesia. Post-operative VAS and complications (Clavien Dindo-Grading System) were recorded. Preservation of urinary continence and erectile and ejaculatory function were assessed according to ISI, MSHQ-EjD and SHIM questionnaires. Post-operative IPSS, QoL, Qmax and PVR were also assessed at 1, 3, and 6 months post-operatively.
This interim report includes data out to 6 months on the first 70 patients enrolled in the study. The median age was 62.31 years, and the mean prostate volume was 37.68 ml (15-80 ml). Baseline and follow-up data are reported in Table 1. No intraoperative complications were observed, the average post-operative VAS score was 3.24 ± 2.56. On average patients returned to daily life after 4.3 days following the retrieval procedure. Sexual function and urinary continence were preserved in all subjects according to the ISI, SHIM and MSHQ-EjD questionnaires and significant improvements (p < 0.0001) from baseline levels were recorded in IPSS, QoL and peak flow.
iTind is a well-tolerated, minimally invasive treatment for BPH-related LUTS which preserves sexual function and urinary continence, offers a rapid recovery and return to daily life, and a significant improvement of symptoms and urinary flow at 6-month follow-up.
World journal of urology. 2020 Aug 26 [Epub ahead of print]
Cosimo De Nunzio, Francesco Cantiello, Cristian Fiori, Fabio Crocerossa, Piero Tognoni, Daniele Amparore, Valeria Baldassarri, Javier Reinoso Elbers, Fernando Gomez Sancha, Francesco Porpiglia
Department of Urology, Ospedale Sant'Andrea, La Sapienza University, Rome, Italy. ., Azienda Ospedaliero-Universitaria Mater Domini, Magna Graecia University of Catanzaro, Catanzaro, Italy., San Luigi Gonzaga di Orbassano University Hospital, Orbassano, Italy., IRCCS AOU San Martino, Genova, Italy., Department of Urology, Ospedale Sant'Andrea, La Sapienza University, Rome, Italy., ICUA - Clínica CEMTRO, Madrid, Spain.