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%.

Emerging minimally invasive transurethral treatments for benign prostatic hyperplasia: a systematic review with meta-analysis of functional outcomes and description of complications.

INTRODUCTION: Several minimally invasive surgical procedures have been proposed as alternative therapies for benign prostatic hyperplasia (BPH). The present systematic review aimed to describe the functional outcomes and complications of emerging minimally invasive transurethral treatments for BPH. EVIDENCE ACQUISITION: A comprehensive bibliographic search on the Medline and Cochrane Library databases was conducted. No chronological restriction was applied. Retrospective and prospective primary studies were included. A meta-analysis of IPSS, IPSS-QoL, Qmax, and PVR was performed. Data on adverse events were presented narratively. EVIDENCE SYNTHESIS: A total of 18 studies were included. Thirteen papers were eligible for the meta-analysis. iTIND (Medi-Tate Ltd., Or-Akiva, Israel), Rezum (Rezum System, Boston Scientific, Marlborough, MA), and Aquablation (AquaBeam System, PROCEPT BioRobotics Inc., Redwood City, CA, USA) were associated with a significant improvement in IPSS (P<0.001), IPSS-QoL (P<0.001), and Qmax (P<0.001) compared to baseline. A significant reduction of PVR from baseline was found with Rezum (P<0.001) and Aquablation (P<0.001) but not iTIND (P=0.22). A significant difference in IPSS, IPSS-QoL, and Qmax was shown in favor of Aquablation compared to Rezum and iTIND (P<0.001). Rezum and iTIND were mainly associated with mild to moderate adverse effects. Hematuria or bleeding was reported in all studies regarding Aquablation (0.8-26%), the need for transfusion or intervention for bleeding varied between 1.8% and 9%. CONCLUSIONS: Aquablation, Rezum, and iTIND significantly improve urinary functional outcomes compared to baseline; however, Aquablation would seem to lead to better functional results compared to the other procedures. Rezum and iTIND appear to have an excellent safety profile, while Aquablation would seem to expose patients to a non-negligible risk of bleeding.

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.

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.

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.

From "gold standard" resection to reproducible "future standard" endoscopic enucleation of the prostate: what we know about anatomical enucleation.

BACKGROUND: Open prostatectomy (OP) and transurethral resection of the prostate (TURP) have traditionally been the most common surgical approaches for the treatment of benign prostatic hyperplasia causing bladder outlet obstruction and have certainly passed the test of time. In time, many endoscopic surgical procedures have been described as an alternative mini-invasive treatment. Holmium laser enucleation (HoLEP) guaranteed functional outcomes similar to OP and TURP with lower perioperative complication rates for any prostate size. With the development of different kinds of lasers (such as thulium, "green light" and diode) and bipolar energy, the feasibility of endoscopic enucleation using these energies has been explored. EVIDENCE ACQUISITION: In this paper, recent techniques to perform true prostate enucleation have been reviewed through a search of PubMed and Web of Science, including articles published in the last 20 years in clinical journals. The review is based on a peer-review process of the authors after a structured data search. Search terms included "Thulium prostate enucleation, THULEP, TmLEP/Tm Yag enucleation" OR "Greenlight enucleation/prostate enucleation/vapo-enucleation/KTP prostate enucleation, PVP prostate enucleation, GreenLep/" OR "bipolar prostate enucleation" OR "HoLEP, Holmium prostate enucleation" OR "monopolar prostate enucleation" OR "Diode prostate enucleation" OR "DiLEP" OR "Eraser prostate enucleation" OR "ELEP". EVIDENCE SYNTHESIS: Following the example of HoLEP, many techniques have been described in the literature using a variety of energy sources and instruments either in a pure enucleative or a hybrid (mixed) fashion. However, the levels of evidence are too low and follow-up still too short to offer solid recommendations. CONCLUSIONS: HoLEP has become the conceptual and practical paradigm for the wide spread of enucleation thanks to the evidence provided by the literature and excellent outcomes. Higher level of evidence is required to assess efficacy of alternative enucleative techniques.

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.

Highly specific detection of prostate-specific antigen-positive cells in the blood of patients with prostate cancer or benign prostatic hyperplasia, using a real-time reverse-transcription-polymerase chain reaction method with improved sensitivity.

OBJECTIVE: To assess the presence of circulating prostate-specific antigen (PSA)-expressing cells in patients with prostate cancer or benign prostatic hyperplasia (BPH), and to determine their diagnostic usefulness using a highly sensitive quantitative real-time reverse-transcription polymerase chain reaction (qRT-PCR) method. PATIENTS, SUBJECTS AND METHODS: Venous blood samples were obtained from 175 patients with prostate cancer (12 metastatic and 163 not metastatic), 49 with BPH, and 50 healthy volunteers. To improve the specificity and sensitivity of the qRT-PCR three innovative features were combined; a primer overlapping two adjacent exons to inhibit nonspecific amplification; a no-end-point first round amplification to increase the sensitivity; and a target-specific primer for the RT phase to increase the specificity. RESULTS: The sensitivity of the method was 1 cell/mL of blood and the interassay coefficient of variation was 10.5%. None of the healthy subjects tested positively, while 9% of those with prostatic cancer and 14% with BPH had PSA-positive cells in the blood. There was a positive association between a positive test and the National Comprehensive Cancer Network classification in the patients with newly diagnosed prostate cancer (P = 0.022). There were no additional statistically significant associations. CONCLUSION: Our results strongly indicate that although there were no false-positive results and the sensitivity of the method was increased to maximal levels, a low frequency of positive results in patients with prostatic cancer and a high frequency of positive results in those with BPH seems to discourage the use of PSA-positive circulating cells in the search for a clinical diagnosis of prostate cancer.

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.