Temporary implantable nitinol device for benign prostatic hyperplasia-related lower urinary tract symptoms: over 48-month results.

BACKGROUND: This study (MT02) reports >48-month (50-79 months) results of a prospective, single-arm, multicenter study (NCT02145208) of temporary implantable nitinol device (iTind®) in men with benign prostatic hyperplasia (BPH)-related lower urinary tract symptoms (LUTS). METHODS: Men with symptomatic BPH (International Prostate Symptom Score [IPSS] ≥10, Maximum flow rate [Qmax] <12 mL/s, and prostate volume <75 mL) from 9 centers were enrolled from December 2014 to December 2016. Total 50/81 (62%) patients at 3/9 sites (Italy, Switzerland, and Belgium), pursued the study beyond 36 months following iTind® device, per study protocol. Due to COVID-19, follow-up was amended. Each patient was assessed once during 50-79 months postoperatively for IPSS and IPSS-quality of life (IPSS-QoL), change in medication, need for surgical re-treatment and adverse events telephonically. RESULTS: Post 36 month-follow-up, 5 patients were lost to follow-up and 2 patients died unrelated to iTind® device placement. Two patients (36-48 months follow-up) required surgical re-treatments (1 transurethral resection of prostate, 1 Thulium laser enucleation of prostate). >48 months results were available for 41 patients wherein iTind® device treatment showed significant improvement in symptoms (IPSS: -45.3%, P<0.0001 and IPSS-QoL: -45.1%, P<0.0001) from baseline to 79 months post-procedure; mean±SD of 11.26±7.67 and 2.10±1.41 points, respectively. No complications were recorded between 36 up to 79 months; no patient required additional medication. CONCLUSIONS: iTind® device provided significant and durable symptom reduction and improved IPSS-QoL for >48 months post treatment. No late postoperative complications were reported beyond 36 months of follow-up. Surgical re-treatment rate for >36 months was 4%.

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

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.

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.

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.

All you need to know about "Aquablation" procedure for treatment of benign prostatic obstruction.

INTRODUCTION: In recent years, technological advances and new approaches have been developed for the treatment of benign prostatic obstruction (BPO) in order to reduce complications like bleeding, retrograde ejaculation and risk of infection while obtaining an adequate disobstruction. The most recent surgical approach introduced is the Aquablation system (PROCEPT BioRobotics, Redwood Shores, CA, USA). This intervention is a robotically guided system that uses high-velocity water jets in order to ablate prostatic tissue, with real-time ultrasound guidance. The aim of this review is to summarize the current evidence on Aquablation and its results, compared to the reported outcomes of the gold standard treatment, the transurethral resection of the prostate (TURP). EVIDENCE ACQUISITION: A systematic review of the Literature was performed in June 2019 using Medline (via PubMed), Embase (via Ovid), and Cochrane databases. The studies that compared the Aquablation to the standard TURP were included. Moreover, a critical review of the single arm studies was conducted. EVIDENCE SYNTHESIS: The results of this systematic review, based on a single RCT that compared Aquablation vs. TURP in prostates 30-80 cc in size, confirmed that Aquablation has at least a similar efficacy as TURP, but has a better safety profile, allows shorter resection times, and has a lower risk of retrograde ejaculation. Moreover, in some subcategories of patients (e.g., when prostate volume is >50 cc) functional outcomes of Aquablation are better than those of TURP. Evidence from non-comparative clinical studies and from real life scenarios have confirmed that Aquablation may be used effectively for prostate volumes up to 150 cc. CONCLUSIONS: The Aquablation procedure for the treatment of BPO allows high clinical efficacy with an excellent safety profile. For prostate volume 30-80 cc, comparative studies demonstrated that this procedure offers clinical results at least comparable to those of conventional TURP. Latest evidence showed that Aquablation may be used effectively for prostate volumes up to 150 cc. The major strengths are its high-speed resection time, low complication rate, and potential for sexual function preservation.

En-bloc endoscopic enucleation of the prostate: a systematic review of the literature.

INTRODUCTION: Transurethral resection of the prostate (TURP) remains the gold standard for treatment of benign prostatic hyperplasia (BPH). Yet, the introduction of lasers for the treatment of LUTS due to BPO has dramatically changed the surgical landscape of benign prostatic obstruction (BPO) treatment. Recently, "en-bloc" techniques have shown to prove advantageous in terms of better visualization, more prompt identification of the surgical capsule and the correct plane to dissect. Herein we provide a comprehensive overview of available series of en-bloc enucleation of the prostate, focusing on surgical techniques, perioperative and functional outcomes. EVIDENCE ACQUISITION: A systematic review of the literature was performed according to PRISMA recommendations and was conducted on surgical techniques and perioperative outcomes of minimally invasive en-bloc surgery for prostate adenoma detachment. EVIDENCE SYNTHESIS: Overall, 16 studies with 2750 patients between 2003 and 2019 were included. Specific technical nuances have been described to maximize perioperative outcomes of en-bloc prostatic enucleation, including early apical release, horse-shape incisions, inverted U-shape tractions and low power. Overall, regardless of the energy employed, en-bloc prostatic enucleation achieved favorable outcomes including low risk of major complications and quality of life improvement. However, a great heterogeneity of study design, patients' inclusion criteria, prostate volume and en-bloc surgical strategy was found. CONCLUSIONS: En-bloc endoscopic enucleation of the prostate has been shown to be technically feasible and safe, with potential technical advantages over the classic three-lobe technique. Larger comparative studies are needed to evaluate the ultimate impact of the en-bloc approach on postoperative outcomes, in light of the surgeon's learning curve.

Follow-up of Temporary Implantable Nitinol Device (TIND) Implantation for the Treatment of BPH: a Systematic Review.

PURPOSE OF REVIEW: The purpose of the present systematic review is to offer a narrative synthesis of the available literature regarding the role of the temporary implantable nitinol device (TIND) (Medi-Tate®; Medi-Tate Ltd., Or Akiva, Israel) for the treatment of benign prostatic hyperplasia (BPH)-related lower urinary tract symptoms (LUTS), specifically focusing on the follow-up data. RECENT FINDINGS: Current available evidences are limited in this topic. Sample size of patients available for analysis is small. Moreover, the duration of follow-up period is intermediate and longer follow-up is required. At the available 3 years follow-up, the TIND implantation is safe, effective, and well tolerated. The extended follow-up of the first and only available cohort of patients who underwent TIND for LUTS related to BPH corroborated previous literature findings. Further studies are required in order to assess the durability of TIND outcomes over a longer follow-up, to better define the indications of this approach, and to demonstrate the advantages of second-generation device over the first.

3-Year follow-up of temporary implantable nitinol device implantation for the treatment of benign prostatic obstruction.

OBJECTIVES: To report 3-year follow-up results of the first implantations with a temporary implantable nitinol device (TIND® ; Medi-Tate Ltd., Or Akiva, Israel) for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: In all, 32 patients with LUTS were enrolled in this prospective study. The study was approved by the local Ethics Committee. Inclusion criteria were: age >50 years, International Prostate Symptom Score (IPSS) ≥10, peak urinary flow (Qmax ) <12 mL/s, and prostate volume <60 mL. The TIND was implanted within the bladder neck and the prostatic urethra under light sedation, and removed 5 days later in an outpatient setting. Demographics, perioperative results, complications (according to Clavien-Dindo classification), functional results, and quality of life (QoL) were evaluated. Follow-up assessments were made at 3 and 6 weeks, and 3, 6, 12, 24 and 36 months after the implantation. The Student's t-test, one-way analysis of variance and Kruskal-Wallis tests were used for statistical analyses. RESULTS: At baseline, the mean (standard deviation, sd) patient age was 69.4 (8.2) years, prostate volume was 29.5 (7.4) mL, and Qmax was 7.6 (2.2) mL/s. The median (interquartile range, IQR) IPSS was 19 (14-23) and the QoL score was 3 (3-4). All the implantations were successful, with a mean total operative time of 5.8 min. No intraoperative complications were recorded. The change from baseline in IPSS, QoL score and Qmax was significant at every follow-up time point. After 36 months of follow-up, a 41% rise in Qmax was achieved (mean 10.1 mL/s), the median (IQR) IPSS was 12 (6-24) and the IPSS QoL was 2 (1-4). Four early complications (12.5%) were recorded, including one case of urinary retention (3.1%), one case of transient incontinence due to device displacement (3.1%), and two cases of infection (6.2%). No further complications were recorded during the 36-month follow-up. CONCLUSIONS: The extended follow-up period corroborated our previous findings and suggests that TIND implantation is safe, effective and well-tolerated, for at least 36 months after treatment.

Temporary implantable nitinol device (TIND): a novel, minimally invasive treatment for relief of lower urinary tract symptoms (LUTS) related to benign prostatic hyperplasia (BPH): feasibility, safety and functional results at 1 year of follow-up.

OBJECTIVES: To report the first clinical experience with a temporary implantable nitinol device (TIND; Medi-Tate(®) ) for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: In all, 32 patients with LUTS were enrolled in this prospective study, which was approved by our Institutional Ethics Committee. Inclusion criteria were: age >50 years, International Prostate Symptom Score (IPSS) of ≥10, maximum urinary flow rate (Qmax ) of ≤12 mL/s, and prostate volume of <60 mL. The TIND was implanted within the bladder neck and the prostatic urethra under light sedation, using a rigid cystoscope. The device was removed 5 days later in an outpatient setting. Demographics, perioperative results, complications (according to the Clavien system), functional results and quality of life (QoL) were evaluated. Follow-up assessments were made at 3 and 6 weeks, and 3, 6 and 12 months postoperatively. The Student's t-test, analysis of variance (anova), Kruskall-Wallis test, and simple and multiple linear regression models were used in the statistical analyses. RESULTS: The mean patient age was 69.4 years, the mean (standard deviation, sd) prostate volume was 29.5 (7.4) mL and the Qmax was 7.6 (2.2) mL/s. The median (interquartile range, IQR) IPSS was 19 (14-23) and QoL score was 3 (3-4). All the implantations were successful, with no intraoperative complications recorded. The mean operative time (sd) was 5.8 (2.5) min and the median (IQR) postoperative stay was 1 (1-2) day. All but one of the devices (96%) was removed 5 days at after implantation in an outpatient setting. Four complications (12.5%) were recorded, including urinary retention (one, 3.1%), transient incontinence due to device displacement (one, 3.1%), prostatic abscess (one, 3.1%), and urinary tract infection (one, 3.1%). Multiple regression analysis failed to identify any independent prognostic factor for complications. There were statistically significant differences in the IPSS, QoL score and Qmax when comparing pre- and postoperative results at every time point. After 12 months, the median (IQR) IPSS and QoL score were 9 (7-13) and 1 (1-2), respectively, and the mean (sd) Qmax was 12 (4.7) mL/s. The mean variations with respect to baseline conditions at the same time points were -45% for the IPSS and +67% for Qmax . At 12 months after surgery (last follow-up visit), no patients required medical therapy or surgical procedures for BPH. CONCLUSION: TIND implantation is a feasible and safe minimally invasive option for the treatment of BPH-related LUTS. The functional results are encouraging and the treatment significantly improved patient QoL. Further studies are required to assess durability of TIND results and to optimise the indications of such a procedure.