Urinary Continence Restoration Through an Endourethral Device: A 3-Month Pilot Study on 10 Patients.

Background: Stress urinary incontinence (SUI) is a widespread and frustrating condition that affects millions of people worldwide, with severe consequences on patients' quality of life and health care systems' costs. Currently, the most severe cases of SUI are treated using implanted (and rather invasive) extraurethral artificial sphincters. The authors propose an innovative, minimally invasive endourethral device for the treatment of SUI. Methods: Ten patients with SUI were enrolled in three Italian centers and underwent device implantation. After 10, 30, 60, and 90 days, correct device position was confirmed by ultrasonography. Improvements in continence and quality of life were evaluated through a 24-hour pad-test, an International Consultation on Incontinence Questionnarie-Short Form (ICI-Q) and a custom checklist. The device was explanted after 90 days. Results: The proposed device was successfully implanted and explanted in 8 out of 10 patients. The results of the pad-test, ICI-Q, and custom checklist demonstrated remarkable improvements in continence (median improvement: 82% with respect to the initial condition) and quality of life (mean reduction of the impact of urine losses on the quality of life: 61%). No major pain or discomfort was reported. Conclusions: The results demonstrate the efficacy of the proposed endourethral artificial sphincter in addressing SUI. The proposed device was successfully implanted and explanted in a short time (∼10 minutes) without intrinsic side effects and without triggering pain or discomfort.

Transperineal laser ablation of the prostate as a treatment for benign prostatic hyperplasia and prostate cancer: The results of a Delphi consensus project.

Objective: To evaluate transperineal laser ablation (TPLA) with Echolaser® (Echolaser® TPLA, Elesta S.p.A., Calenzano, Italy) as a treatment for benign prostatic hyperplasia (BPH) and prostate cancer (PCa) using the Delphi consensus method. Methods: Italian and international experts on BPH and PCa participated in a collaborative consensus project. During two rounds, they expressed their opinions on Echolaser® TPLA for the treatment of BPH and PCa answering online questionnaires on indications, methodology, and potential complications of this technology. Level of agreement or disagreement to reach consensus was set at 75%. If the consensus was not achieved, questions were modified after each round. A final round was performed during an online meeting, in which results were discussed and finalized. Results: Thirty-two out of forty invited experts participated and consensus was reached on all topics. Agreement was achieved on recommending Echolaser® TPLA as a treatment of BPH in patients with ample range of prostate volume, from <40 mL (80%) to >80 mL (80%), comorbidities (100%), antiplatelet or anticoagulant treatment (96%), indwelling catheter (77%), and strong will of preserving ejaculatory function (100%). Majority of respondents agreed that Echolaser® TPLA is a potential option for the treatment of localized PCa (78%) and recommended it for low-risk PCa (90%). During the final round, experts concluded that it can be used for intermediate-risk PCa and it should be proposed as an effective alternative to radical prostatectomy for patients with strong will of avoiding urinary incontinence and sexual dysfunction. Almost all participants agreed that the transperineal approach of this organ-sparing technique is safer than transrectal and transurethral approaches typical of other techniques (97% of agreement among experts). Pre-procedural assessment, technical aspects, post-procedural catheterization, pharmacological therapy, and expected outcomes were discussed, leading to statements and recommendations. Conclusion: Echolaser® TPLA is a safe and effective procedure that treats BPH and localized PCa with satisfactory functional and sexual outcomes.

A single-operator experience using EchoLaser SoracteLiteTM for focal laser ablation of prostate cancer: One more arrow in the quiver for the conservative management of the disease.

BACKGROUND: The aim of this study was to evaluate the outcomes of patients suffering prostate cancer (PCa) treated conservatively using 1064 nm laser energy for focal laser ablation (FLA). The patients included in the study were unsuitable for surgery or unwilling to receive external beam radiotherapy because they were afraid of the possible side effects of whole-gland therapies. METHODS: This study included patients with a diagnosis of nonmetastatic PCa who underwent FLA using SoracteLiteTM system. Tissue ablation was performed at a fixed power of 5 W by the diode multichannel laser system EchoLaser X4 that uses laser light transmitted through optical fibres causing the target tissue to undergo irreversible thermal damage. Functional outcomes were evaluated with the International Prostatic Symptoms Score (IPSS) and 5-item version of the International Index of Erectile Function (IIEF-5) before the treatment and one year later. RESULTS: Ten patients suffering non-metastatic PCa were included. Four decided upon a conservative treatment because of reduced performance status and for six patients the procedure was chosen electively. All patients underwent multiparametric magnetic resonance imaging at 3 and 12 months and eight out of ten patients underwent prostate biopsy at 6 months. Persistent disease was detected in 3 patients who underwent a second ablation. In these patients at the biopsy following the second ablation none harbored residual disease. At follow-up, no patient suffered urinary incontinence requiring the use of pads. No significant worsening in sexual potency measured with IIEF-5 (p = 0.356) or prostatic symptoms measured at IPSS (p = 0.462) were recorded comparing pre-treatment condition vs one-year follow-up. Compared with baseline, prostate-specific antigen was significantly reduced at one-year follow-up (3.7 ± 1.1 vs 7.9 ± 4.1 ng/mL; p = 0.008). CONCLUSIONS: Although whole gland therapies remain the gold standard treatment for PCa, our results indicate that the SoracteLiteTM system for focal laser ablation, as a very preliminary step, appears to offer a short-term oncologic control of PCa with negligible side effects.

Is prostate-specific antigen percentage decrease predictive of clinical outcome after permanent iodine-125 interstitial brachytherapy for prostate cancer?

OBJECTIVE: To determine the usefulness of prostate-specific antigen (PSA) percentage (vs. pretreatment value assumed as 100%) in prediction of biochemical relapse, after iodine-125 ((125)I) permanent brachytherapy for prostate cancer, to employ a parameter independent by the initial PSA amount and by the individual prostatic volume. METHODS AND MATERIALS: Our study included 133 patients, 102 still disease free (Group A) and 31 who experienced proven biochemical recurrence (Group B). PSA levels before and after (125)I brachytherapy were recorded, and PSA percentage vs. pretreatment values were calculated. Cox regression model, receiver operating characteristic curves, and Kaplan-Meier regression model with log-rank test were calculated. RESULTS: We observed that, in patients submitted to brachytherapy for prostate cancer, a PSA percentage >20% of pretreatment value is highly associated with relapse risk (p<0.0001) and that this association is strongly present since t=6 months of followup (p<0.0001), with a hazard ratio near to five times (4.965), a sensitivity of 72.4%, and specificity of 79.8% related to the chosen cutoff. DISCUSSION: Despite the amount of PSA is the only parameter that the clinicians can deploy to monitor patient's followup after permanent interstitial brachytherapy for prostate cancer, its evolution in time seems unable to predict early biochemical relapse as it is influenced by prostatic volume and initial PSA amount. CONCLUSIONS: Our data suggest that a PSA percentage >20% of pretreatment value at 6 months might represent an early, inexpensive, and useful predictive tool of bad outcome in patients after permanent brachytherapy.

Transperineal microwave thermoablation in patients with obstructive benign prostatic hyperplasia: a phase I clinical study with a new mini-choked microwave applicator.

PURPOSE: To evaluate the tolerability and safety of a newly designed probe for trans-perineal microwave thermoablation (TPMT) of the prostate in patients with benign prostatic hyperplasia (BPH), and the in vivo microwave effects on prostatic tissue. PATIENTS AND METHODS: Nine patients with obstructive BPH who were candidates for open prostatectomy were selected for this study. Under local anesthesia and transrectal ultrasound monitoring, all patients underwent a single standardized application of TPMT. The visual analog scale (VAS) and Short Form-36 health survey (SF-36) questionnaire were administered to each patient prior to, during, and 1 month after TPMT in order to evaluate pain and quality of life. Then the International Index of Erectile Function (IIEF-5) and International Prostate Symptom Score (IPSS) questionnaires were administered to each patient at baseline and 1 month after prostatectomy in order to evaluate sexual and urinary function, respectively. Then all patients were divided into three groups and underwent open prostatectomy 7, 15, and 30 days after TPMT, respectively. The prostatic adenomas were then evaluated by a pathologist. RESULTS: No adverse events from TPMT treatment were noted. In particular, no patients reported local, pelvic, or abdominal pain during the procedure or subsequent alterations of defecation rhythm, ano-rectal/intestinal problems, or hematuria. No differences in quality of life or in sexual function were reported. The diameters of the lesions obtained with TPMT treatment ranged from 16 to 18.1 mm in all patients. Quasi-spheroid lesions with a well-defined area of complete coagulative necrosis were documented in all removed adenomas 7, 15, and 30 days after TMPT. CONCLUSIONS: The AMICA-PROBE is a safe, well-tolerated, and repeatable method to treat BPH with microwave thermotherapy. The spheroid lesions obtained demonstrated the maximal control over the radial and longitudinal coagulative effects of the therapy. Phase II studies are needed to further evaluate the efficacy of this new probe.

Prevalence, incidence estimation, risk factors and characterization of chronic prostatitis/chronic pelvic pain syndrome in urological hospital outpatients in Italy: results of a multicenter case-control observational study.

PURPOSE: We evaluated the prevalence and estimated the incidence and risk factors of chronic prostatitis/chronic pelvic pain syndrome in urological hospital outpatients in Italy. MATERIALS AND METHODS: From January to June 2006 patients from 28 Italian urological centers who were between 25 and 50 years old with symptoms of chronic prostatitis/chronic pelvic pain syndrome were consecutively enrolled in this prospective epidemiological case-control study. A total of 152 subjects of similar age, race and area of origin who were investigated for infertile couples but were otherwise healthy served as controls. All subjects provided a medical history and underwent different symptom scorings, clinical evaluation and microbiological tests. RESULTS: Of 5,540 male urological outpatients 764 with chronic prostatitis/chronic pelvic pain syndrome were enrolled, including 225 (29.4%) at the first presentation and 539 (70.6%) who underwent previous treatment. Thus, the prevalence of the syndrome was 13.8%, while the estimated incidence was 4.5%. Cigarette smoking, a high caloric diet with low fruit and vegetable consumption, constipation, meteorism, slow digestion, a sexual relationship with more than 1 partner and coitus interruptus were more likely in patients with chronic prostatitis/chronic pelvic pain syndrome than in controls (each p <0.001). The syndrome had a negative influence on sexual desire, erectile dysfunction and premature ejaculation (p <0.001). The Meares and Stamey test was positive in 13.3% of patients and in 2.9% of controls. Urethral swabs in patients with a negative Meares and Stamey test were positive for sexually transmitted pathogens in 6%. CONCLUSIONS: The prevalence and estimated incidence of chronic prostatitis/chronic pelvic pain syndrome in urological hospital outpatients in Italy are high. The syndrome is closely related to lifestyle, diet, smoking, gastrointestinal or anorectal disease and impaired sexual function.

Intravesical gemcitabine in BCG-refractory T1G3 transitional cell carcinoma of the bladder: a pilot study.

OBJECTIVE: The aim of this pilot study is to analyze the safety and short-term efficacy of gemcitabine (GEM) as salvage intravesical therapy in a very selected population of bacille Calmette-Guérin (BCG)-resistant T1G3 patients. METHODS: 9 recurrent BCG-refractory pT1G3 patients, unsuitable for radical treatment, were treated with GEM, and compared with 10 pT1G3 patients previously treated with at least two courses of transurethral resection plus BGC, with further conservative endovesical BCG administration. RESULTS: Both intravesical administrations of GEM and BCG were generally well tolerated: no severe adverse events were reported. Of the 9 patients treated with GEM, 3 were recurrence-free after 13, 17 and 21 months and 7 kept an intact bladder, with an overall survival rate of 9 of 9. Among 10 patients treated with BCG instillation, 1 was recurrence-free after 27 months and 6 kept their bladders, with a survival rate of 8 of 10. CONCLUSIONS: Our experience confirms the high risk of tumor recurrence and progression of BCG-refractory pT1G3 transitional cell carcinoma. In this case, further BCG courses seem to be unsuitable, resulting in a high risk of tumor progression and mortality. The use of GEM in BCG-refractory pT1G3 patients has to be considered experimental until multicentric randomized studies with adequate follow-up are able to confirm the preliminary results of this pilot study.