Category: BPH/LUTS: Electrosurgery, Lasers & Other Technology

MP6-1 - MediTate® second generation temporary implantable nitinol device (i-TIND) as a minimally invasive treatment for LUTS management: results of one arm, multicenter prospective study

Fri, Sep 21
10:00 AM - 12:00 PM

Introduction & Objective :

Temporary Implantable Nitinol Device (TIND - MediTate®) is a device for the minimally invasive treatment of lower urinary tract symptoms (LUTS) due to benign prostatic obstruction (BPO). 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 BPO.


Methods :

The i-TIND is comprised of three nitinol elongated struts and an anchoring leaflet. 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 17F cystoscope. The device was removed 5 days later in an outpatient setting, with no need of anesthesia. To enroll the patients in the study the 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. Demographics, perioperative, functional results and quality of life (QoL) were evaluated. For the purpose of this study we reported the results of 3, 6 and 12 months follow-up.


Results :

81 patients with LUTS were enrolled in this multi-center study from Oct 2014. Mean patients' age were 63.9 (+8.9) and BMI was 26.6 (+3.6). Mean prostate volume, median IPSS score, median QoL and mean Qmax were 35.3 (+12.5) cc, 22 (11;35), 4 (2;5), and 8.46 (+7.54) ml/sec, respectively. All the implantations and the removals of devices were successfully concluded with no intraoperative complications. Three months, six months and 12 months after implantation mean Qmax was 12.48 (+7.54) ml/sec, 15.22 (+9.82) ml/sec and 14.72 (+8.17) ml/sec respectively. At the same timepoints the median IPSS score was 8 (1;34), 7 (0;29) and 7 (1;31), while the median QoL were 2 (0;5), 2 (0;5) and 1 (0;4), respectively. No patients reported ejaculatory dysfunction during follow-up. Differences in terms of IPSS score, QoL and Qmax when comparing preoperative and 12 months postoperative results were statistically significant (p<0.05); specifically the mean change from baseline to month 12 in IPSS score was -12.36 (9.33) and the mean change of Qmax was +5.62 (7.92) ml/sec (p<0.001 for both variables). The functional results recorded 6 months after surgery were maintained stable at one year. During the follow up no patients required pharmacologic treatment and only one patient needed surgery for BPO.


Conclusions :

Second generation i-TIND implantation is a safe and effective minimally-invasive option for the treatment of BPH related LUTS until one year follow up. 

Francesco Porpiglia

Full Professor of Urology
Department of Urology, AOU San Luigi Gonzaga Orbassano – Turin; University of Turin
Orbassano, Piemonte, Italy

Cristian Fiori

Department of Urology, AOU San Luigi Gonzaga Orbassano – Turin; University of Turin
Orbassano, Piemonte, Italy

Daniele Amparore

Department of Urology, AOU San Luigi Gonzaga Orbassano – Turin; University of Turin
Orbassano, Piemonte, Italy

Andrea Giordano

Department of Urology, AOU San Luigi Gonzaga Orbassano – Turin; University of Turin
Orbassano, Piemonte, Italy

Arya Manit

Department of Urology, Rivers Hospital London, United Kingdom
London, England, United Kingdom

Gregor Kadner

Department of Urology, Spital Thurgau, Frauenfeld, Switzerland
Frauenfeld, Thurgau, Switzerland

Massimo Valerio

Urology, University Hospital of Lausanne, Lausanne, Switzerland
Lausanne, Vaud, Switzerland

Neil Barber

Frimley Park Hospital, Camberley, United Kingdom
Camberley, England, United Kingdom

Nicolaas Lumen

Department of Urology, Gent University, Gent, Belgium
Gent, Namur, Belgium

Brian Ho

Department of Urology, Queen Mary Hospital, Hong Kong
Hong Kong, Not Applicable, Hong Kong

Claude Schulman

Department of Urology, CHIREC Cancer Institute (CCI), Urology Brussels, Belgium
Bruxelles, Brussels Hoofdstedelijk Gewest, Belgium