Virtually Competent: A Comparative Analysis of Virtual Reality and Dry-Lab Robotic Simulation Training.

Background: Virtual reality (VR) and dry-lab simulation have been widely validated for robotic surgical training. Both modalities are used during the early stages of the learning curve, yet, no comparative analysis of the two modalities has been undertaken. This study compares the effectiveness of VR and dry-lab simulation for basic robotic surgical skill training. Methods: A comparative study of 43 robotic novices was undertaken at two centers in the United Kingdom and Italy. Participants were allocated to either VR or dry-lab simulation and completed a robotic simulation training program. On completion, all participants were assessed by performing a urethrovesical anastomosis on a synthetic model. Technical proficiency was measured by two trained raters using the Global Evaluative Assessment of Robotic Skills (GEARS) tool. All participants completed a qualitative posttraining assessment questionnaire. Results: Baseline characteristics were equal between the two groups. Both VR and dry-lab training led to a significant improvement in technical proficiency. Overall mean GEARS scores increased by 5.6 and 2.5 following dry-lab and VR simulation training, respectively (p = 0.034). Dry-lab training showed significantly greater improvements than VR simulation, but only after the third training session. Both techniques were highly rated by participants. Conclusions: Both VR and dry-lab simulation were effective in improving robotic surgical skill but were not equal. For more advanced skill training, dry-lab training was found to be superior to VR simulation. Dry-lab training offers specific benefits to robotic surgical training and should remain a principal component of the simulation curriculum.

Phase I study of a new tablet-based image guided surgical system in robot-assisted radical prostatectomy.

Robot-assisted radical prostatectomy is, currently, the most commonly utilized procedure for the treatment of localized prostate cancer. Image-guided surgical systems have been proposed in the literature as a valuable tool for the better utilization of the preoperative data in theatre. In this Phase 1 trial, we tested the feasibility and safety of a new, cutting-edge tablet-based surgical imaging system designed for robot-assisted radical prostatectomy (RARP). It utilizes the preoperative MRI images of the prostate, mapping them intra-operatively, real time to the patient by magnetic tracking to fixed points of the pelvis. The system is comprised of a tablet computer with a touch screen display; a tracking system housed in a portable cart, a magnetic field generator and position sensors. It updates image data over 20 times per second to compensate with anatomical alterations during the operation. Four patients diagnosed with prostate adenocarcinoma were enrolled in this study. All four had negative surgical margins along with satisfactory functional recovery regarding continence and potency. The navigational accuracy and the real time information provided by the imaging system was mainly utilized in the more challenging parts of the operation including the apical dissection, the nerve sparing procedure and the bladder neck dissection. The system proved to be safe and its clinical efficacy is due to be assessed with a Phase II clinical study.

Cognitive training for technical and non-technical skills in robotic surgery: a randomised controlled trial.

OBJECTIVE: To investigate the effectiveness of motor imagery (MI) for technical skill and non-technical skill (NTS) training in minimally invasive surgery (MIS). SUBJECTS AND METHODS: A single-blind, parallel-group randomised controlled trial was conducted at the Vattikuti Institute of Robotic Surgery, King's College London. Novice surgeons were recruited by open invitation in 2015. After basic robotic skills training, participants underwent simple randomisation to either MI training or standard training. All participants completed a robotic urethrovesical anastomosis task within a simulated operating room. In addition to the technical task, participants were required to manage three scripted NTS scenarios. Assessment was performed by five blinded expert surgeons and a NTS expert using validated tools for evaluating technical skills [Global Evaluative Assessment of Robotic Skills (GEARS)] and NTS [Non-Technical Skills for Surgeons (NOTSS)]. Quality of MI was assessed using a revised Movement Imagery Questionnaire (MIQ). RESULTS: In all, 33 participants underwent MI training and 29 underwent standard training. Interrater reliability was high, Krippendorff's α = 0.85. After MI training, the mean (sd) GEARS score was significantly higher than after standard training, at 13.1 (3.25) vs 11.4 (2.97) (P = 0.03). There was no difference in mean NOTSS scores, at 25.8 vs 26.4 (P = 0.77). MI training was successful with significantly higher imagery scores than standard training (mean MIQ score 5.1 vs 4.5, P = 0.04). CONCLUSIONS: Motor imagery is an effective training tool for improving technical skill in MIS even in novice participants. No beneficial effect for NTS was found.

A Case Series of Patients Who Underwent Laparoscopic Extraperitoneal Radical Prostatectomy with the Simultaneous Implant of a Penile Prosthesis: Focus on Penile Length Preservation.

PURPOSE: There are many grey areas in the field of penile rehabilitation after radical prostatectomy (RP). The preservation of the full dimensions of the penis is an important consideration for improving patients' compliance for the treatment. We present the first case series of patients treated by laparoscopic extraperitoneal RP and simultaneous penile prosthesis implantation (PPI) in order to preserve the full length of the penis and to improve patients' satisfaction. MATERIALS AND METHODS: From June 2013 to June 2014, 10 patients underwent simultaneous PPI (with an AMS InhibiZone prosthesis) and RP. Patients were evaluated by means of urological visits, questionnaires, and objective measurements before surgery, at discharge from the hospital, on postoperative days 21 to 28, each 3 months for the first year, and each 6 months thereafter. The main outcome measures were biochemical recurrence-free rate, penile length, and quality of life. RESULTS: Ten patients (mean age of 61 years; completed the study follow-up period (median, 32.2 months). No difference was found between the time of surgery and the 2-year follow-up evaluation in terms of penile length. The pre-surgery 36-Item Short Form Health Survey (SF-36) median score was 97. Patients were satisfied with their penile implants, and couples' level of sexual satisfaction was rated median 8. The median postoperative SF-36 score was 99 at 3 months follow-up. CONCLUSIONS: Laparoscopic extraperitoneal RP surgery with simultaneous PPI placement seems to be an interesting possibility to propose to motivated patients for preserving the length of the penis and improving their satisfaction.

Florence robotic intracorporeal neobladder (FloRIN): a new reconfiguration strategy developed following the IDEAL guidelines.

OBJECTIVE: To describe our step-by-step technique for robotic intracorporeal neobladder configuration, including the stages of conception, development and exploration of this surgical innovation, according to the Idea, Development, Exploration, Assessment, Long-term follow-up (IDEAL) Collaboration guidelines. PATIENTS AND METHODS: The Florence robotic intracorporeal neobladder (FloRIN) was performed employing the following main surgical steps: isolation of 50 cm of ileum; bowel anastomosis; urethro-ileal anastomosis creating an asymmetrical 'U'-shape (30 cm distally and 20 cm proximally to anastomosis), ileum detubularisation; posterior wall reconfiguration as an 'L'; bladder neck reconstruction; anterior folding of the posterior plate to reach the 12 o'clock position; uretero-enteral 'orthotopic' bilateral anastomosis. The conception and development of the FloRIN followed the IDEAL guidelines recommended stages: Phase 1 (simulation) involved the neobladder robotic configuration using silicone models. Phase 2a (development) aimed to reproduce the configuration in an open fashion in one patient, and then in the first three robotic procedures. Phase 2b (exploration) consisted of the technique standardisation in 15 consecutive robotic approaches. Phase 2a and 2b included urodynamics and imaging assessment of the patients treated. RESULTS: From February 2016 to September 2017 FloRIN was performed in 18 patients. Comparing the first three (Phase 2a) with the subsequent 15 patients (Phase 2b), the median (interquartile range [IQR]) reconstruction operating time was 260 (220-340) vs 160 (150-210) min, respectively. Postoperative surgical complications occurred in four of the 18 patients (22.1%), including one surgical Clavien-Dindo Grade III and three Grade I, postoperative medical Clavien-Dindo Grade II complications occurred in three (16.7%) patients. On urodynamic examination (available in nine [50%] patients) the median (IQR) reservoir cystometric capacity, compliance, and post-void residual were 240 (220-267) mL, 18 (12.5-19.8) mL/cmH2 O, and 0 (0-50) mL, respectively. Ultrasonography showed no Grade ≥2 vesico-ureteric reflux. CONCLUSION: We describe the FloRIN configuration, showing its technical feasibility with acceptable time efficiency. The first cases studied had good reservoir capacity, low pressure with no reflux, and complete voiding.

Penile prosthesis surgery in out-patient setting: Effectiveness and costs in the "spending review" era.

INTRODUCTION: Penile implant patients are required to remain in the hospital after the operation for monitoring, antibiotic and analgesia administration. Cost containment, however, has resulted in the increased use of ambulatory surgery settings for many surgical procedures. Few studies have studied the feasibility of performing penile prosthesis insertion in an outpatient setting. The results are controversial and nowadays, in the most of centers that deal with prosthetic surgery, patients are still hospitalized. AIM: The aim of our investigation was to compare the feasibility of the performance as well as the complication profiles of penile implant surgery performed in an in-patient and an outpatient setting at a single center by a single surgeon. METHODS: From January 2009 to June 2014, 50 patients of the same uro-andrological unit underwent penile prosthesis implantation performed by a single surgeon (N.M.). Twenty implantations were performed in an ambulatory day surgery setting. MAIN OUTCOME MEASURES: Effectiveness and costs of outpatient setting versus the in-patient setting of the penile prosthesis surgery. RESULTS: There were some differences between the two groups in the intra-operative parameters, such as, operating time. Time lost from work was similar in both groups approximating 14 days. The mean number of analgesic pills ingested by the patients post-operatively was similar in both groups, averaging just under 25 pills per patient. There weren't post-operative complications in the outpatient group. Cost were 17% less in outpatient clinic. CONCLUSIONS: The outpatient setting for this surgery is safe and effective even in patients with comorbidities or in case of secondary procedures. Costs are reduced by 17%.

Development and implementation of centralized simulation training: evaluation of feasibility, acceptability and construct validity.

UNLABELLED: WHAT'S KNOWN ON THE SUBJECT? AND WHAT DOES THE STUDY ADD?: A competent urologist should not only have effective technical skills, but also other attributes that would make him/her a complete surgeon. These include team-working, communication and decision-making skills. Although evidence for effectiveness of simulation exists for individual simulators, there is a paucity of evidence for utility and effectiveness of these simulators in training programmes that aims to combine technical and non-technical skills training. This article explains the process of development and validation of a centrally coordinated simulation program (Participants - South-East Region Specialist Registrars) under the umbrella of the British Association for Urological Surgeons (BAUS) and the London Deanery. This program incorporated training of both technical (synthetic, animal and virtual reality models) and non-technical skills (simulated operating theatres). OBJECTIVES: To establish the feasibility and acceptability of a centralized, simulation-based training-programme. Simulation is increasingly establishing its role in urological training, with two areas that are relevant to urologists: (i) technical skills and (ii) non-technical skills. MATERIALS AND METHODS: For this London Deanery supported pilot Simulation and Technology enhanced Learning Initiative (STeLI) project, we developed a structured multimodal simulation training programme. The programme incorporated: (i) technical skills training using virtual-reality simulators (Uro-mentor and Perc-mentor [Symbionix, Cleveland, OH, USA], Procedicus MIST-Nephrectomy [Mentice, Gothenburg, Sweden] and SEP Robotic simulator [Sim Surgery, Oslo, Norway]); bench-top models (synthetic models for cystocopy, transurethral resection of the prostate, transurethral resection of bladder tumour, ureteroscopy); and a European (Aalborg, Denmark) wet-lab training facility; as well as (ii) non-technical skills/crisis resource management (CRM), using SimMan (Laerdal Medical Ltd, Orpington, UK) to teach team-working, decision-making and communication skills. The feasibility, acceptability and construct validity of these training modules were assessed using validated questionnaires, as well as global and procedure/task-specific rating scales. RESULTS: In total 33, three specialist registrars of different grades and five urological nurses participated in the present study. Construct-validity between junior and senior trainees was significant. Of the participants, 90% rated the training models as being realistic and easy to use. In total 95% of the participants recommended the use of simulation during surgical training, 95% approved the format of the teaching by the faculty and 90% rated the sessions as well organized. A significant number of trainees (60%) would like to have easy access to a simulation facility to allow more practice and enhancement of their skills. CONCLUSIONS: A centralized simulation programme that provides training in both technical and non-technical skills is feasible. It is expected to improve the performance of future surgeons in a simulated environment and thus improve patient safety.

Face, content and construct validity of a virtual reality simulator for robotic surgery (SEP Robot).

INTRODUCTION: This study aims to establish face, content and construct validation of the SEP Robot (SimSurgery, Oslo, Norway) in order to determine its value as a training tool. SUBJECTS AND METHODS: The tasks used in the validation of this simulator were arrow manipulation and performing a surgeon's knot. Thirty participants (18 novices, 12 experts) completed the procedures. RESULTS: The simulator was able to differentiate between experts and novices in several respects. The novice group required more time to complete the tasks than the expert group, especially suturing. During the surgeon's knot exercise, experts significantly outperformed novices in maximum tightening stretch, instruments dropped, maximum winding stretch and tool collisions in addition to total task time. A trend was found towards the use of less force by the more experienced participants. CONCLUSIONS: The SEP robotic simulator has demonstrated face, content and construct validity as a virtual reality simulator for robotic surgery. With steady increase in adoption of robotic surgery world-wide, this simulator may prove to be a valuable adjunct to clinical mentorship.

Effectiveness of procedural simulation in urology: a systematic review.

PURPOSE: We analyzed studies validating the effectiveness and deficiencies of simulation for training and assessment in urology. We documented simulation types (synthetic, virtual reality and animal models), participant experience level and tasks performed. The feasibility, validity, cost-effectiveness, reliability and educational impact of the simulators were also evaluated. MATERIALS AND METHODS: The MEDLINE®, EMBASE™ and PsycINFO® databases were systematically searched until September 2010. References from retrieved articles were reviewed to broaden the search. RESULTS: The study included case reports, case series and empirical studies of training and assessment in urology using procedural simulation. The model name, training tasks, participant level, training duration and evaluation scoring were extracted from each study. We also extracted data on face, content and construct validity. Most studies suitably addressed content, construct and face validation as well as the feasibility, educational impact and cost-effectiveness of simulation models. Synthetic, animal and virtual reality models were demonstrated to be effective training and assessment tools for junior trainees. Few investigators looked at the transferability of skills from simulation to real patients. CONCLUSIONS: Current simulation models are valid and reliable for the initial phase of training and assessment. For advanced and specialist level skill acquisition animal models can be used but availability is limited due to supply shortages and ethical restrictions. More research is needed to validate simulated environments for senior trainees and specialists.

Clinical importance of lymph node density in predicting outcome of prostate cancer patients.

BACKGROUND: To evaluate the prognostic role of lymph node density (LND) in patients affected by prostate cancer (PCa) and treated with radical prostatectomy (RP), pelvic lymph node dissection (PLND), and adjuvant hormonal blockade. METHODS: A total of 124 consecutive patients with lymph node positive PCa formed the basis of this report. Clinical and pathological parameters were collected. All patients were stratified in two groups according to LND: Group A (LND ≤ 32%) and Group B (LND ≥ 33%). Time to the first biochemical recurrence (BCR) was the main measure of outcome. RESULTS: Mean number of lymph nodes removed was 5.2 (range 1-17). The mean number of positive lymph nodes was 1.6 (range 1-5). At a mean follow-up of 84.3 mo, 22 patients in Group A (43.1%) and 40 in Group B (54.7%) had BCR. The mean overall BCR-free survival was 46.2 mo (range 8-90). No significant correlation was found between the number of positive lymph nodes and BCR-free survival (P = 0.68). In addition, the patients with LND ≥ 33% had a poor prognosis with significantly decreased disease-specific and BCR-free survival rates (hazard ratio: 0.48; 95% CI, 0.28-0.78; P = 0.0039). At multivariate and artificial neural network (ANN) analyses, LND, Gleason score, and stage were identified as independent prognostic factors of BCR-free survival (P = 0.002; P = 0.003; P = 0.003). CONCLUSIONS: The current study highlights the role of LND in predicting BCR-free survival in patients with lymph node positive PCa after prostatectomy. It also reinforces the need for a stratification of patients with nodal metastasis.

Current status of robotic partial nephrectomy.

PURPOSE OF REVIEW: In recent years, robotic partial nephrectomy has emerged as a technique for treatment of small renal masses alongside laparoscopic and open partial nephrectomy. Since this technique is still in a phase of adoption, many technical improvements, alterations and early experiences are published. We aim to review the recent literature, focus on recent advances in techniques and give an overview of published series. RECENT FINDINGS: Recent series confirm the feasibility of robotic partial nephrectomy and demonstrate perioperative data and short-term oncological outcomes that are at least comparable to laparoscopic series. The development of better renorrhaphy techniques and optimal use of the robotic features to gain console surgeon independence seem to be the main focus. Also alternative hilar control, early unclamping and off-clamp techniques are being developed to lower the ischaemic effect on the kidney. The learning curve seems to be less steep than laparoscopic techniques. CONCLUSION: Robotic partial nephrectomy proves to be a well tolerated and efficacious minimally invasive option in the treatment of renal lesions. Main areas of interest are decreasing warm ischaemia time and modified renal closure techniques.

Regular moderate intake of red wine is linked to a better women's sexual health.

INTRODUCTION: While some evidence does exist for a positive correlation between moderate wine intake and men's sexual health, there is no study addressing the potential correlation between red wine intake and women's sexual function. AIM: The aim of our study was to assess whether there is a tie between daily red wine intake and sexual function in a sample of healthy Italian women, living in the Chianti area (Tuscany) not complaining of any sexual disorders. METHODS: We recruited 798 women (age 18-50), living in the Chianti area (Tuscany), not complaining of any sexual disorders. We divided the participants into three groups: daily moderate (one to two glasses) red wine intake (group 1); teetotallers (group 2); and daily intake of more than two glasses of red wine and/or other types of alcoholic drinks (including white wine), as well as of those reporting occasional drinking (group 3). MAIN OUTCOME MEASURES: All participants completed anonymously the Female Sexual Function Index (FSFI) questionnaire and were asked to report on their amount and type of alcohol consumption. RESULTS: Group 1 had significantly higher total (P = 0.001), as well as desire and lubrication domain (P = 0.001 and P = 0.001, respectively) FSFI scores than participants in groups 2 and 3. No significant differences between the groups were observed concerning sexual arousal, satisfaction, pain, and orgasm. Univariate analysis showed a significant correlation between age, alcohol consumption (P = 0.009), and a better score at questionnaire examination. During multivariate analysis, alcohol consumption was identified as an independent prognostic parameter (P = 0.002) in predicting the better score at questionnaire examination. CONCLUSIONS: The finding that regular moderate intake of red wine is associated with higher FSFI scores for both sexual desire, lubrication, and overall sexual function as compared to the teetotaller status is intriguing. While this finding needs to be interpreted with some caution, because of the small sample size, self-reported data, and the lack of support from laboratory exams, it nevertheless suggests a potential relationship between red wine consumption and better sexuality.

Prostate growth and prevalence of prostate diseases in early onset spinal cord injuries.

BACKGROUND: Controversial data on modifications of prostate size, function and disease of spinal cord injury (SCI) patients has been previously reported. OBJECTIVE: An analytical observational cohort study on male SCI patients was planned in order to evaluate prostate gland growth, including benign prostatic hyperplasia in relation to the age of the patient at SCI onset. Additional evaluations considered hormonal and biochemical parameters and prostate cancer. DESIGN, SETTING AND PARTICIPANTS: 113 SCI patients (mean age 61.3) and 109 age-matched able bodied subjects (mean age 65.4) were enrolled and stratified according to the patient age at SCI onset (< or = 30, 31-49, and > or = 50 years). INTERVENTION: A complete medical history was then collected from all SCI patients and able bodied subjects. MEASUREMENTS: Total prostate antigen (PSA) and testosterone (T) serum levels and urine culture were collected. Digital rectal examination and transrectal ultrasonography were performed. RESULTS AND LIMITATIONS: Patients with SCI showed PSA value and prostate size significantly lower than those observed in able bodied subjects, and an inverse relationship was observed in SCI patients between these two parameters and patient age at the time of lesion onset. T serum levels were lower in SCI patients when compared to able bodied subjects. No SCI patient presented prostate cancer, while 9.7% of control subjects were affected by prostate cancer. CONCLUSIONS: Prostate volume and PSA levels are lower in SCI patients and are inversely related to the patient age at lesion onset. Whether this effect is mediated directly or indirectly by a impaired nerve supply to the prostate remains to be determined. Despite the present observation of reduced prostate disease, as during the last twenty years life expectancy in SCI patients has improved significantly, the need to screen these patients for the occurrence of prostate disease should not be disregarded.

Infected congenital urethral diverticulum manifested as a scrotal mass in an adult male: case report and review of the literature.

Congenital anterior urethral diverticula in adult males are infrequent urological diseases. Clinical manifestation is frequently described with irritative and/or obstructive voiding symptoms or ventral bulging, but manifestation as a scrotal mass is extremely rare. Diagnostic imaging is useful to correctly diagnose the above in the majority of cases. We report the first case of a urethral diverticulum in which neither clinical nor instrumental evaluations were performed to confirm the diagnosis of urethral diverticulum. We stress the importance of a surgical approach in evaluating scrotal mass if diagnostic imaging cannot confirm an exact diagnosis. A complete review of the literature was also carried out.

Recurrent renal colic in young people: abdominal Munchausen syndrome--a diagnosis not to forget.

The Munchausen's syndrome (MHS) is a rare psychiatric disorder classified among the self-manipulated diseases. Incidence of Munchausen syndrome peaks in young-to-middle-aged adults, but it has been reported in patients of all ages (ie, childhood through advanced age). Diagnosing Munchausen syndrome is very difficult, but early diagnosis could to a considerable extent prevent the iatrogenic risks. Indeed, the management of Müchhausen syndrome is aggravated by the low compliance in these patients. We report an unusual case of MHS in urological practice, in order to demonstrate that the MHS is an underestimated and laborious to diagnose syndrome. A 25-year-old single female affected by recurrent episodes of renal colic was admitted to our institution, reporting right acute flank pain and at least two previous periods of hospitalization due to bilateral acute flank pain with no evidence of urinary calculi or either morphological or functional alterations. Neither the urodynamic study nor abdominal CT scan nor pelvic NMR revealed any morphological or functional alterations. In order to exclude a multiple sclerosis, an encephalic NMR and neurological evaluation were also performed. At this stage, suspicion was raised regarding the possible factitious nature of her problem and a psychiatric consultation was made. On the basis of psychiatric consultation and the symptoms resolution with simple intravenous saline solution infusions, the diagnosis of factitious illness (Munchausen syndrome) was confirmed. In the present case report, we stress the fact that the MHS is an underestimated medical problem and the necessity to evaluate the possible role of psychiatric disorders in the absence of pathological findings.

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.

Finasteride 5 mg and sexual side effects: how many of these are related to a nocebo phenomenon?

INTRODUCTION: Sexual adverse experiences such as erectile dysfunction (ED), loss of libido, and ejaculation disorders have been consistent side effects of finasteride in a maximum percentage of 15% after 1 year of therapy. Such data could be seen as far from reality, if compared to a higher percentage that may be found in any common clinical practice. AIM: This study aims to explain the dichotomy between literature's data and clinical practice data. METHODS: One hundred twenty patients with a clinical diagnosis of benign prostatic hyperplasia (BPH), sexually active and with an International Index of Erectile Function-erectile function (IIEF-EF) domain >/=25 were randomized to receive finasteride 5 mg concealed as an "X compound of proven efficacy for the treatment of BPH" for 1 year with (group 2) or without (group 1) counseling on the drug sexual side effect. The phrase used to inform group 2 patients was ". . . it may cause erectile dysfunction, decreased libido, problems of ejaculation but these are uncommon". MAIN OUTCOME MEASURES: The estimation of side effect was conducted at 6 and 12 months using the male sexual function-4 (MSF-4 item) questionnaire and a self-administered questionnaire. RESULTS: One hundred seven patients completed the study. Group 2 patients (N = 55) reported a significant higher proportion of one or more sexual side effects as compared to group 1 (N = 52) (43.6% vs. 15.3%) (P = 0.03). The incidence of ED, decreased libido, and ejaculation disorders were 9.6, 7.7, and 5.7% for group 1, and 30.9, 23.6, and 16.3% for group 2, respectively (P = 0.02, P = 0.04, and P = 0.06). CONCLUSION: In the current study, blinded administration of finasteride was associated with a significantly higher proportion of sexual dysfunction in patients informed on sexual side effects (group 2) as compared to those in which the same information was omitted (group 1) (P = 0.03). A scenario similar to group 2 of the current study is likely to occur in clinical practice, where the patient is counseled by the physician and has access to the drug information sheet. The burden of this nocebo effect (an adverse side effect that is not a direct result of the specific pharmacological action of the drug) has to be taken into account when managing finasteride sexual side effects.

Interleukin 8 and anti-chlamydia trachomatis mucosal IgA as urogenital immunologic markers in patients with C. trachomatis prostatic infection.

OBJECTIVE: This study evaluates the role of interleukin 8 (IL-8) and anti-Chlamydia trachomatis (CT) immunoglobulin A (IgA) in total ejaculate (TE) of patients affected by chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) as potential markers in prostatic CT infection. METHODS: Seventy-eight consecutive patients with a diagnosis of CP/CPPS and CT infection were enrolled; 20 healthy volunteers represented the control group. All subjects underwent microbiologic analysis for common bacteria, yeasts, and viruses in TE, expressed prostatic secretion, and urine samples and molecular analysis for CT identification, anti-CT species-specific IgA, and IL-8 levels. Questionnaires regarding symptoms were given to each subject to determine correlations between clinical and laboratory data. RESULTS: Thirty-five patients were positive for CT plasmid DNA, but none of the controls were positive. Mucosal IgA was detected in 69.2% of patients and significant levels of IL-8 were detected in 75.6% of them. Significant correlations between IL-8 and mucosal IgA (p<0.001) and between IL-8 levels and symptom score results (p<0.001) were found. IL-8 values strongly correlated with CP/CPPS (p<0.001). Moreover, the patients with higher levels of IL-8 and higher positivity for IgA reported the worst symptoms. CONCLUSIONS: Our results clearly highlight the role of immune system activation in the pathophysiology of CP/CPPS and that seminal IL-8 and mucosal IgA levels specific to CT antigens appear to be the best immunologic markers of chronic chlamydial prostatitis status.

Alfuzosin (10 mg) does not affect blood pressure in young healthy men.

OBJECTIVES: Alfuzosin 10mg is a uroselective alpha(1)-adrenoceptor antagonist used to treat lower urinary tract symptoms suggestive of benign prostatic hyperplasia. Recent studies have suggested the potential efficacy of alfuzosin in the treatment of distal ureteral stones and prostatitis syndrome, two conditions frequently encountered in young patients. The objective of this study was to evaluate the effect of 10mg alfuzosin on blood pressure (BP) and heart rate (HR) in young healthy volunteers. MATERIALS AND METHODS: In a randomized, double-blind, placebo-controlled, crossover study, the effect of alfuzosin 10mg on BP and HR was evaluated in 14 male volunteers (mean age: 28 yr; range: 24-30). BP<135/85 obtained in two separated measurements was a main inclusion criterion. Patients were then randomized to alfuzosin (10mg once a day) or placebo for 1 wk, followed by a washout week, and then crossed over to the other treatment. Patients were instructed to self-measure systolic (SBP) and diastolic (DBP) blood pressure and HR every hour between 8am and 8pm during the first and the last day of each cycle treatment. RESULTS: All 14 enrolled volunteers completed the study. No significant difference in either SBP, DBP, or HR was observed between the placebo and alfuzosin groups at baseline. Alfuzosin did not affect SBP, DBP, or HR. No hypotensive episode (SBP reduction >10%) was recorded during each treatment. CONCLUSIONS: This study shows that alfuzosin 10mg is well tolerated by young healthy subjects and may therefore be safely administered to young normotensive patients affected by distal ureteral stones and prostatitis.

Accuracy of prostate volume measurements using transrectal multiplanar three-dimensional sonography.

The aim of this study is to evaluate the accuracy of three-dimensional (3D) ultrasound in comparison with conventional bidimensional (2D) sonography in prostatic calculations. The study was performed using a Kretztechnik Voluson 530D machine with a 7.5 MHz endocavitary transducer. From March 1998 to March 2000, we examined 80 patients (63-74 years, mean 68 years). There were 59 patients with benign prostate hypertrophy (BPH) and 21 with prostate cancer awaiting a radical prostatectomy. The mean absolute error in 3D ultrasound measurement was +/-0.2-3 mL. (range of error was 6.5%). Volume measurement using 2D ultrasound methods was much less accurate than 3D ultrasound methods: +/-0.4-5 mL. (range of error was 35%). Both 2D and 3D measurements show that the margin of error depends on the frequent presence of a third prostatic lobe, on the morphology, and on the size of the prostatic gland. The precise estimation of prostate volumes may provide information on the real effectiveness of some therapies that act on the reduction in volume of benign alteration, such as in prostatic hypertrophy, and may eliminate the current limits of 2D sonography with a significant clinical contribution for virtually no extra cost.