Abstract: PD27-03
Sources of Funding: none

Introduction

Temporary Implantable Nitinol Device (TIND - MediTate®) is a new device for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). We already published the feasibility and safety of TIND implantation, herein we report the results of a one-arm, multi-center, international prospective study to assess the efficacy of second generation of MediTate i-TIND in subjects with BPH.

Methods

The i-TIND is comprised of three nitinol elongated struts and an anchoring leaflet and it is preloaded by crimping it into the delivery system. In expanded configuration, the struts of the i-TIND exert radial force that causes ischemic necrosis and subsequent incisions of bladder neck and prostatic urethra. i-TIND was implanted under light sedation, using a rigid 22F cystoscope. The device was removed 5 days later in an outpatient setting, with no need of anesthesia. Forty patients with LUTS were enrolled in this multi-center study from Oct 2014. Inclusion criteria were: IPSS score ? 10, peak urinary flow (Qmax) < 12 ml/sec and prostate volume < 75 cc. All patients discontinued medical therapy for BPH before the implantation._x000D_ Demographics, perioperative, functional results and quality of life (QoL) were evaluated. For the purpose of this study we reported the results of 3 and 6 months follow-up._x000D_

Results

Patients' age (mean+ SD) was 65.7 y (9.1) and BMI (mean+ SD) was 26.5 (4.1). Prostate volume (mean+ SD), IPSS score (median, range), QoL (median, range) and Qmax (mean+ SD), were 35.3 (+12.5) cc, 25(13-35), 4 (2-5), and 7.5 (2.87) ml/sec respectively. All the implantations and the removals of device were successfully concluded with no intraoperative complications. Three months after implantation IPSS score, QoL and Qmax were 7 (1-29), 1 (0-5) and 12.4ml/sec (4.9); after six months were 7 (0-29), 2 (0-4) and 14 ml/sec (+6.01) respectively. No patients reported ejaculatory dysfunction during follow-up. Differences in terms of IPSS score, QoL and Qmax when comparing preoperative and 6 months postoperative results were statistically significant (p<0.05); specifically the mean change from baseline to month 6 in IPSS score was -15.33 and the mean change of Qmax was 6.2 ml/sec. During the follow up no patients required pharmacologic treatment or surgery for BPH.

Conclusions

Second generation i-TIND implantation is a safe and effective minimally-invasive option for the treatment of BPH related LUTS at least at short term follow up. Further studies are required to assess durability of these results. _x000D_ _x000D_

Funding

none