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%.

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.

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.

Oligometastatic adrenocortical carcinoma: the role of image-guided thermal ablation.

OBJECTIVES: To evaluate the impact of image-guided ablation of liver and lung metastases from adrenocortical carcinoma (ACC). METHODS: Patients with oligometastatic ACC (liver and lung metastases) who underwent image-guided ablation were retrospectively included in the study. Complete ablation (CA) at the first contrast-enhanced CT control, local tumor progression (LTP), local tumor progression-free survival (LTPFS), liver disease-free survival (LDFS), and overall survival (OS) were evaluated. Correlation between outcomes and other prognostic factors (including Ki67, hormonal secretion, and progression-free survival after primary tumor resection (PR-PFS)) was also analyzed. Kaplan-Meier methods, log-rank tests, and Spearman correlation models were applied. RESULTS: Thirty-two ACC metastases (4 lung and 28 liver) from 16 patients (10 females; mean age 41 years) were treated with RFA or MWA. A single major adverse event was observed (intrahepatic hematoma with subsequent right hemothorax). One patient (2 lesions) was lost to follow-up. CA was obtained in 97% (29/30). During follow-up, LTP was registered in 7/29 cases (24.1%), with a median LTPFS of 21 months (± 12.6). Metastasis size was significantly higher in case of LTP (20 mm vs. 34.5 mm; p = 0.009) and was an independent predictive factor of local tumor control with an AUC of 0.934 (p = 0.0009). Hepatic progression was observed in 66% of the cases, with a median LDFS of 25 months. Median OS was 48.6 months. PR-PFS and hormonal secretion were independent predictors of OS (p < 0.001 and p = 0.045, respectively). CONCLUSIONS: Image-guided ablation achieves adequate local tumor control of ACC liver and lung metastases, providing a safe and effective treatment option in the multidisciplinary management of the oligometastatic ACC. KEY POINTS: • Image-guided ablation allows adequate local tumor control in the oligometastatic adrenocortical carcinoma setting. • After percutaneous thermal ablation, complete ablation was achieved in 29 out of 30 lesions (97%). • Lesion size together with primary resection disease-free survival and hormonal secretion play a significant role in determining outcomes.

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.

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.

Bipolar endoscopic enucleation versus bipolar transurethral resection of the prostate: an ESUT systematic review and cumulative analysis.

PURPOSE: To perform a cumulative analysis of the current evidence on the surgical and functional outcomes of bipolar endoscopic enucleation of the prostate (b-EEP) versus bipolar transurethral resection of the prostate (b-TURP). METHODS: A systematic review of the literature was performed on PubMed, Ovid®, and Scopus® according to Preferred Reporting Items for Systematic Review and Meta-analysis Statement (PRISMA Statement). The meta-analysis was conducted using the Review Manager 5.3 software. Parameters of interest were surgical and functional outcomes. Weighted mean difference, and odds ratio with 95% confidence interval were calculated for continuous and binary variables, respectively. Pooled estimates were calculated using the random-effect model. RESULTS: Fourteen comparative studies were included. No statistically significant difference in terms of overall baseline characteristics was found. b-EEP had higher amount of resected tissue (p < 0.0001), shorter catheter time (p = 0.006), lower Hb drop (p = 0.03), and shorter length of stay (p < 0.0001). Equally, overall post-operative complications were lower (p = 0.01) as well as short (p = 0.04), and long-term complication rate (p = 0.04). There was higher re-intervention rate in the b-TURP group (p = 0.02) whereas b-EEP group had smaller residual prostate volume (p = 0.03), and lower post-operative PSA values (p < 0.00001). At long term, b-EEP presented lower IPSS (p = 0.04), higher Qmax (p = 0.002), and lower PVR (p < 0.00001). CONCLUSIONS: b-EEP is an effective and safe surgical treatment for BPO. This procedure might offer several advantages over standard b-TURP, including the resection of a larger amount of tissue within the same operative time, shorter hospitalization, lower risk of complications, and lower re-intervention rate. This was submitted to PROSPERO registry: CRD42019126748.

Major Acute Cardiovascular Events After Transurethral Prostate Surgery: A Population-based Analysis.

OBJECTIVE: To test the prevalence and predictors of major acute cardiovascular events (MACE) after transurethral prostate surgery (TPS). MATERIAL AND METHODS: The American College of Surgeons National Surgical Quality Improvement Program database (2011-2016) was queried for patients who underwent transurethral resection of the prostate, photoselective vaporization, or laser enucleation. MACE included: cerebrovascular events, cardiac arrest, myocardial infarction, deep venous thrombosis requiring therapy, and pulmonary embolism episodes occurred up to 30 days after discharge. Univariable and multivariable logistic regression models tested MACE predictors and effect of MACE on perioperative mortality. Within covariates significant at univariable analyses a stepwise selection, based on Akaike Information Criterion values, was performed to fit the most appropriate multivariable model. RESULTS: Overall 44,939 patients were included in our analyses. Of these 365 (0.8%) had MACE within 30 days after surgery. The strongest MACE predictors were recent congestive heart failure (odds ratio [OR]: 2.1, 95% confidence interval [CI]: 1.2-3.7, P = .007), transfusions (OR: 2.5, 95% CI: 1.5-4.1, P <.001) and preoperative Systemic Inflammatory Response Syndrome or sepsis (OR: 2.6, 95% CI: 1.6-4.2, P <.001). Similarly, inpatient (OR: 2.0, 95% CI: 1.6-2.5, P <.001) and nonelective (OR: 1.5, 95% CI: 1.1-2.1, P = .012) patients experienced higher MACE rates. Perioperative mortality rates were statistical significantly higher in MACE patients (OR: 13.1, 95% CI: 8.2-21.0, P <.001). CONCLUSION: Up to 1% of patients undergoing transurethral prostate surgery experience MACE. MACE are burdened by high mortality rates (up to 14% in MACE patients). Proper patient selection and postoperative monitoring are necessary to reduce MACE incidence and mortality rates.

The role of 68Ga-PSMA PET/CT scan in biochemical recurrence after primary treatment for prostate cancer: a systematic review of the literature.

INTRODUCTION: Recurrence after primary treatment of prostate cancer is one of the major challenges facing urologists. Biochemical recurrence is not rare and occurs in up to one third of the patients undergoing radical prostatectomy. Management of biochemical recurrence is tailored according to the site and the burden of recurrence. Therefore, developing an imaging technique to early detect recurrent lesions represents an urgent need. Positron emission tomography (PET) of 68Ga-labelled prostate-specific membrane antigen (68Ga-PSMA) is an emerging imaging modality that seems to be a promising tool with capability to localize recurrent prostate cancer. A systematic review of literature was done to evaluate the role of 68Ga-PSMA PET/CT scan in patients with recurrent prostate cancer after primary radical treatment. EVIDENCE ACQUISITION: A systematic and comprehensive review of literature was performed in September 2017 analyzing the MEDLINE and Cochrane Library following the Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) statement. The following key terms were used for the search "PSMA," "prostate-specific membrane antigen," "positron emission tomography," "PET," "recurrent," "prostate cancer," "prostate neoplasm," "prostate malignancy," and "68Ga." Risk of bias was assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 tool. EVIDENCE SYNTHESIS: Thirty-seven articles met our inclusion criteria and were included in the analysis of this systematic review. Of the 37 articles selected for analysis only four studies were prospective. The overall detection rate of 68Ga-PSMA PET scan ranged from 47% up to 96.6%. The main advantage of this imaging technique is its relatively high detection rates at low serum PSA levels below 0.5 ng/mL (ranging from 11.1% to 75%). Higher serum PSA level was strongly associated with increased positivity on 68Ga-PSMA PET scan. 68Ga-PSMA PET scan was found superior to conventional imaging techniques (CT and MRI) in this setting of patients and even it seems to outperform choline-based PET scan. This technique provided significant changes in the therapeutic management of 28.6-87.1% of patients. CONCLUSIONS: After biochemical recurrence, the primary goal is to locate the recurrent lesions' site. 68Ga-PSMA PET/CT seems to be effective in identifying recurrence localization also for very low levels of PSA (<0.5 ng/mL) thus permitting to choose the best therapeutic strategy as early as possible. However, data available cannot be considered exhaustive and prospective randomized trials are needed.

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.

Green light vaporization of the prostate: is it an adult technique?

INTRODUCTION: Intending to overcome transurethral resection of the prostate (TURP) in terms of safety maintaining its efficacy profile, have led to the introduction of minimally invasive laser therapies to treat men with lower urinary tract symptoms (LUTS) secondary to benign prostatic obstruction (BPO), each one with its unique properties. The aim of this review was to analyze and summarize all the existing data regarding the 180 W Xcelerated Performance System (XPS) photoselective vaporization of the prostate (PVP). EVIDENCE ACQUISITION: A systematic review was conducted: 45 papers were identified. After excluding those not in English language, duplicates, case reports and "expert opinion" papers, 39 articles were reviewed. EVIDENCE SYNTHESIS: The XPS emits a 532 nm wavelength generated using a lithium triborate crystal in a quasi-continuous mode through a 750 µm, continuously saline-cooled, metal capped MoXy™ fibre. This system has overcome the previous model in terms of surgical and functional outcomes. Although several techniques have been proposed, the IGLU modular one is considered the standard approach for 180 W PVP. Authors estimated the need for at least 120 cases to reach an expert level of competence. The GOLIATH Study has proven the non-inferiority of XPS PVP to TURP. The procedure is safe and effective also in large glands but long operative times still represent an issue. Considering the total average costs, XPS PVP provides and advantage over TURP. International guidelines consider PVP the best option to manage patients receiving anticoagulants or with a high cardiovascular risk. CONCLUSIONS: PVP should be considered an adult technique and, as suggested by the EAU Guidelines, is the best surgical option to manage patients receiving anticoagulant medication or with a high cardiovascular risk. The development of new surgical techniques such as APV, PEBE and seminal spearing approaches could represent a possibility to further implement the XPS indications. Dedicated unit could improve the management LUTS/BPO men.

The fat body mass increase after adjuvant androgen deprivation therapy is predictive of prostate cancer outcome.

Androgen deprivation therapy (ADT) leads to important changes in body composition. No data are currently available about the relationship between these treatment-related changes and patient outcome. Using dual-energy X-ray absorptiometry, bone mineral density (BMD), fat body mass (FBM), and lean body mass (LBM) were determined at baseline, and after 1 and 2 years in 53 non-metastatic prostate cancer (PC) patients with high-risk disease treated with adjuvant ADT. Changes in these parameters were correlated with patient outcome in terms of adverse skeletal events, disease recurrence, and overall survival. ADT led to a significant decrease in BMD (p < 0.03) and LBM (p < 0.03), and an increase in FBM, (p < 0.0001). Changes in BMD failed to show any relationship with time to skeletal-related events (SRE), disease recurrence, and death. FBM increase was a significant predictor of higher risk of SRE [hazard ratio (HR) 3.024, 95 % CI 1.004-10.353, p < 0.02], higher risk of death (HR 2.373, 95 % CI 1.012-5.567, p = 0.04), and a non-significant higher risk of disease recurrence (HR 2.219, 95 % CI 0.956-5.150, p = 0.13). LBM decrease did not correlate with either time to SRE or survival, while a non-significant association with disease recurrence (HR 1.550, 95 % CI 0.670-3.605, p = 0.06) was observed. The early increase in FBM may provide predictive information of poor outcome in PC patients given ADT. These data suggest that the adoption of early preventive measures aiming to reduce fat increase can potentially reduce the morbidity and mortality risk.

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.

Vegetarian low-protein diets supplemented with keto analogues: a niche for the few or an option for many?

BACKGROUND: Low-protein diets are often mentioned but seldom used to slow chronic kidney disease (CKD) progression. The aim of the study was to investigate the potential for implementation of a simplified low-protein diet supplemented with alpha-keto analogues (LPD-KA) as part of the routine work-up in CKD patients. METHODS: In an implementation study (December 2007-November 2011), all patients with CKD Stages IV-V not on dialysis, rapidly progressive Stage III and/or refractory proteinuria, were offered either a simplified LPD-KA, or commercially available low-protein food. LPD-KA consisted of proteins 0.6 g/kg/day, supplementation with Ketosteril 1 pill/10 Kg, 1-3 free-choice meals/week and a simplified schema based on 'allowed' and 'forbidden' foods. 'Success' was defined as at least 6 months on LPD-KA. Progression was defined as reduction in glomerular filtration rate (GFR)[(Chronic Kidney Disease Epidemiology Collaboration) formula CKD-EPI] in patients with at least 6 months of follow-up. RESULTS: Of about 2500 patients referred (8% CKD Stages IV-V), 139 started LPD-KA; median age (70 years) and prevalence of comorbidity (79%) were in line with the dialysis population. Start of dialysis was the main reason for discontinuation (40 cases, unplanned in 7); clinical reasons were recorded in 7, personal preference in 14 and improvement and death in 8 each. The low gross mortality (4% per year) and the progression rate (from -8 to 0 mL/min/year at 6 months) are reassuring concerning safety. None of the baseline conditions, including age, educational level, comorbidity or kidney function, discriminated the patients who followed the diet for at least 6 months. CONCLUSIONS: Our data suggest a wider offer of LPD-KA to patients with severe and progressive CKD. The promising results in terms of mortality and progression need confirmation with different study designs.

Open versus laparoscopy-assisted radical cystectomy: results of a prospective study.

BACKGROUND AND PURPOSE: Laparoscopic radical cystectomy is confined to centers where advanced laparoscopy is performed, and its role is not yet well clear. Our aim was to evaluate, through a prospective comparative study, the advantages of the laparoscopic compared with an open approach. PATIENTS AND METHODS: From November 2002 to December 2005, all the patients in our center who were found to have muscle-invasive bladder cancer without clinical evidence of lymph-node involvement and an American Society of Anesthesiologists (ASA) score <4 were included in a prospective nonrandomized study. Group A (N = 22) underwent open radical cystectomy, whereas group B (N = 20) underwent laparoscopy-assisted radical cystectomy. The two groups were demographically comparable. We evaluated the mean age, clinical stage, ASA score, operative time, blood loss, intraoperative complications and transfusions, type of diversion, time of catheterization, analgesic consumption, start of oral nutrition, rate of postoperative complications, length of hospital stay, pathologic diagnosis of the specimen, number of lymph nodes removed, and the oncologic outcome. RESULTS: No significant statistical difference was observed between the two groups in intraoperative and postoperative parameters except for analgesic consumption and the start of oral nutrition (P < 0.05). The mean operative time was 260 minutes (range 210-290 minutes) for group A and 284 minutes (range 260-305 minutes) for group B. The mean blood loss was 770 mL (range 450-870 mL) in group A and 520 mL (range 400-620 mL) in group B. The rate of autologous transfusion was 18% in group A and 10% in group B. Seventeen ileal diversions and five neobladder creations were performed in group A, whereas the Bricker diversion was used in 10 cases in group B, and a neobladder was chosen in the 10 other cases. CONCLUSION: Laparoscopy-assisted radical cystectomy is a safe procedure, like open surgery, but it offers the advantage of minimal invasiveness, represented by reduced analgesic consumption and early recovery of peristalsis with rapid oral nutrition.

Nifedipine versus tamsulosin for the management of lower ureteral stones.

PURPOSE: We evaluate and compare the effectiveness of 2 different medical therapies during watchful waiting in patients with lower ureteral stones. MATERIALS AND METHODS: A total of 86 patients with stones less than 1 cm located in the lower ureter (juxtavesical or intramural tract) were enrolled in the study and were randomly divided into 3 groups. Group 1 (30) and 2 (28) patients received daily oral treatment of 30 mg deflazacort, (maximum 10 days). In addition group 1 patients received 30 mg nifedipine slow-release (maximum 28 days) and group 2 received 1 daily oral therapy of 0.4 mg tamsulosin (maximum 28 days), Group 3 patients (28) were used as controls. Statistical analyses were performed using Student's test, ANOVA test, chi-square test and Fisher's exact test. RESULTS: The average stone size for groups 1 to 3 was 4.7, 5.42 and 5.35 mm, respectively, which was not statistically significant. Expulsion was observed in 24 of 30 patients in group 1 (80%), 24 of 28 in group 2 (85%) and 12 of 28 in group 3 (43%). The difference in groups 1 and 2 with respect to group 3 was significant. Average expulsion time for groups 1 to 3 was 9.3, 7.7 and 12 days, respectively. A statistically significant difference was noted between groups 2 and 3. Mean sodium diclofenac dosage per patient in groups 1 to 3 was 19.5, 26, and 105 mg, respectively. A statistical significant difference was observed between groups 1 and 2 with respect to group 3. CONCLUSIONS: Medical treatments with nifedipine and tamsulosin proved to be safe and effective as demonstrated by the increased stone expulsion rate and reduced need for analgesic therapy. Moreover medical therapy, particularly in regard to tamsulosin, reduced expulsion time.