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3-Year results following treatment with the second generation of the temporary implantable nitinol device in men with LUTS secondary to benign prostatic obstruction

Prostate Cancer and Prostatic Diseases volume 24, pages 349–357 (2021)Cite this article

Subjects

Abstract

Background

To report the 3-year results of a prospective, single arm, multicenter, international clinical study with the second generation of the temporary implantable nitinol device (iTIND; Medi-Tate Ltd®, Israel) on men suffering lower urinary tract symptoms (LUTS) secondary to benign prostatic obstruction (BPO).

Methods

Eighty-one men with symptomatic BPO (IPSS ≥ 10, peak urinary flow <12 ml/s, and prostate volume <75 ml) were enrolled in this study between December 2014 and December 2016. Subjects were washed-out 1 month for alpha-blockers and 6 months for 5-ARIs. The implantation was performed under light sedation and the removal 5–7 days later with topical anesthesia. Perioperative results including OR-time, pain (VAS) postoperative complications (Clavien–Dindo-Grading System), functional results (Qmax, IPSS, PVR) and quality of life (QoL) were assessed at 1, 3, 6 months, 1, 2, and 3 years. Sexual and ejaculatory function were evaluated using two yes/no questions.

Results

Thirty-six month functional results were available for 50 patients and demonstrated that iTIND efficacy remained stable through 3 years, with averages IPSS, QOL, Qmax and PVR of 8.55 + 6.38, 1.76 + 1.32, 15.2 + 6.59 ml/s and 9.38 + 17.4 ml, improved from baseline by −58.2, −55.6, +114.7, and −85.4% (all significantly different from their corresponding baseline values, p < 0.0001). Even considering the Intention to Treat analysis (ITT), the 36-month results confirmed significant improvements of the functional outcomes if compared with baselines values (all p < 0.0001). No late post-operative complications were observed between 12 and 36 months. Sexual function was stable through 3 years, with no reports of sexual or ejaculatory dysfunctions. No patients underwent alternative treatments between 24 and 36 months.

Conclusion

Treatment of BPO-related LUTS with iTIND demonstrated a significant and durable reduction in symptoms and improvement of functional parameters and quality of life at 3 years of follow-up. No late post-operative complications, ejaculatory dysfunction or additional treatment failures were observed between 24 and 36 months.

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Fig. 1: Structure of the iTIND device.
Fig. 2: Study enrollment flowchart.
Fig. 3: Functional postoperative outcomes.

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Author notes

  1. These authors contributed equally: Gregor Kadner, Francesco Porpiglia

Authors and Affiliations

  1. Division of Urology, San Luigi Hospital, Orbassano, Italy

    Daniele Amparore, Cristian Fiori, Sabrina De Cillis & Francesco Porpiglia

  2. Division of Urology, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland

    Massimo Valerio

  3. Division of Urology, CHIREC Cancer Institute, University of Brussels, Brussels, Belgium

    Claude Schulman

  4. Division of Urology, Kantonsspital Frauenfeld, Frauenfeld, Switzerland

    Ioannis Giannakis & Gregor Kadner

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  1. Daniele Amparore
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Correspondence to Daniele Amparore.

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Amparore, D., Fiori, C., Valerio, M. et al. 3-Year results following treatment with the second generation of the temporary implantable nitinol device in men with LUTS secondary to benign prostatic obstruction. Prostate Cancer Prostatic Dis 24, 349–357 (2021). https://doi.org/10.1038/s41391-020-00281-5

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