Purpose: 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). Methods: 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. Results: 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. Conclusion: 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.
Urinary and sexual function after treatment with temporary implantable nitinol device (iTind) in men with LUTS. 6-month interim results of the MT-06-study / De Nunzio, C.; Cantiello, F.; Fiori, C.; Crocerossa, F.; Tognoni, P.; Amparore, D.; Baldassarri, V.; Elbers, J. R.; Sancha, F. G.; Porpiglia, F.. - In: WORLD JOURNAL OF UROLOGY. - ISSN 0724-4983. - (2020). [10.1007/s00345-020-03418-2]
Urinary and sexual function after treatment with temporary implantable nitinol device (iTind) in men with LUTS. 6-month interim results of the MT-06-study
De Nunzio C.
;Cantiello F.;Baldassarri V.;
2020
Abstract
Purpose: 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). Methods: 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. Results: 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. Conclusion: 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.File | Dimensione | Formato | |
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