A Multicenter, Randomized, Single-blind, 2-Arm Intervention Study Evaluating the Adverse Events and Quality of Life After Irreversible Electroporation for the Ablation of Localized Low-intermediate Risk Prostate Cancer.

PURPOSE: Our goal was to evaluate the effect of focal vs extended irreversible electroporation on side effects, patient-reported quality of life, and early oncologic control for localized low-intermediate risk prostate cancer patients. MATERIALS AND METHODS: Men with localized low-intermediate risk prostate cancer were randomized to receive focal or extended irreversible electroporation ablation. Quality of life was measured by International Index of Erectile Function, Expanded Prostate Cancer Index Composite questionnaire, and International Prostate Symptom Score. RESULTS: A total of 51 and 55 patients underwent focal and extended irreversible electroporation, respectively. The median follow-up time was 30 months. Rates of erectile dysfunction and rates of adverse events were similar between the 2 groups at 3 months. The focal ablation group seemed to have better International Index of Erectile Function scores at 3 months; it also had a better Expanded Prostate Cancer Index Composite-sexual function score than the extended ablation group across time that was close to statistical significance (mean difference 1.4; 95% CI -0.13 to 2.9, P = .073). There were no significant differences between the 2 groups in other quality-of-life measures. Upon prostate biopsy at 6 months, the rate of residual clinically significant prostate cancer (Gleason ≥3 + 4) was 18.8% and 13.2% in the focal and extended irreversible electroporation groups, respectively, without significant differences. CONCLUSIONS: Focal and extended irreversible electroporation ablation had similar safety profile, urinary function, and oncologic outcomes in men with localized low-intermediate risk prostate cancer. In addition, focal ablation demonstrated superior erectile function outcome over extended irreversible electroporation in the first 3-6 months.

A preliminary investigation of a novel method to manipulate penis length to measure female sexual satisfaction: a single-case experimental design.

OBJECTIVES: To investigate a novel methodology and explore whether artificially reducing the depth of penetration during intercourse matters to women. STUDY DESIGN AND METHODS: A study with a single-case experimental design ('n of 1'), in which a heterosexual couple act as their own control and the study is then replicated in subsequent couples, was conducted. Thirty-five couples were assessed for eligibility to participate. Twenty-nine couples without any sexual problems were randomized and 12 submitted sufficient data to analyse. As a proxy for reducing penis length, we artificially reduced the depth of penetration by using different sizes of silicone rings around the base of the man's erect penis. The main outcome measures were provided by the female partner on a scale of 0-100 and comprised: degree of (i) overall sexual pleasure; (ii) sexual pleasure from intercourse alone; and (iii) emotional connection to the male partner. The female partner was also asked before the experiment began to rate the degree of positive or negative change that would be personally meaningful for her. RESULTS: On average, reducing the depth of penetration led to a statistically significant 18% reduction of overall sexual pleasure with an average 15% reduction in length of the penis. The longer the erect penis, the less likely the rings were to have an impact on sexual pleasure. There was a range of individual responses, however, with a minority of women reporting that reducing the depth of penetration was more pleasurable on some occasions. CONCLUSIONS: Size may matter in women in a healthy stable relationship when there is penile shortening. Because of the small number of couples and the inclusion of men with an apparently long penis, our results are preliminary, and we welcome replication in a larger sample with a more diverse range of penile lengths. Our results should not be misinterpreted as meaning that increasing penile length will increase sexual pleasure in women.

Penile length is preserved after implant surgery.

OBJECTIVE: To investigate if there is a correlation between penile size measured preoperatively and erect penis after penile implant surgery (PI). A common cause of patient dissatisfaction after PI is caused by patients complaining that surgery has shortened the penis. It has been suggested that stretched penile length preoperatively is almost the same after surgery when the prosthesis is in erect status. However, no comprehensive data supports this theory. This prospective study was done to investigate this theory. PATIENTS AND METHODS: Standardised measurements of stretched penile length and girth were performed in theatre before PI implantation then re-measured at the end of the procedure with the penis in the erect position. We recorded type of PI, cylinder lengths and malleable rod diameters. All patients had data recorded on body mass index (BMI), hypertension (HTN), glycated haemoglobin (HbA1c ), and Peyronie's disease (PD). RESULTS: In all, 133 patients were assessed; 88 (66.2%) had a malleable penile prosthesis (MPP) and 45 (33.8%) an inflatable penile prosthesis (IPP). The median age and BMI were 56 years and 30 kg/m2 , respectively. In all, 40 (30.1%) patients had HTN, 37 (27.8%) had PD, and 89 (66.9%) were diabetic. The mean (SD) pre-implant stretched length was 12.8 (1.8) cm. The mean (SD) flaccid girth was 10.3 (1.2) cm. Postoperatively, the mean (SD) erect length and girth were 13.1 (1.7) cm and 11.3 (1.3) cm, respectively. Overall, there was a significant (P < 0.05) increase in both the mean (SD) length at +0.36 (0.63) cm, and girth at +1.04 (1.02) cm. Patients who had an IPP, had a greater increase in both length (mean [SD] 0.62 [0.72] cm) and girth (mean [SD] 1.7 [1.0] cm) compared to those who had a MPP (mean [SD] 0.22 [0.53] cm and 0.7 [0.87] cm, respectively) (P < 0.05). We investigated correlations between pre- and postoperative outcomes related to BMI, HTN, diabetes, and PD. None of these variables affected outcome. CONCLUSIONS: PI surgery does not significantly decrease penile size compared to the preoperative assessment. The outcome was not affected by co-morbidities. The preoperative length and girth correlated well with the immediate postoperative erect penis, although girth was not necessarily comparable in this series of patients measured under anaesthesia. Recording penile dimensions in the clinic and agreeing these with patients' preoperatively may be a way of improving satisfaction levels with this surgery.

Clomiphene citrate and human chorionic gonadotropin are both effective in restoring testosterone in hypogonadism: a short-course randomized study.

OBJECTIVES: To compare serum testosterone response and symptom improvement in men with hypogonadism in response to treatment with clomiphene citrate (CC), human chorionic gonadotropin (hCG), or a combination of both therapies. PATIENTS AND METHODS: A total of 282 men with hypogonadism, wishing to preserve their fertility, were randomized to one of three treatment arms: CC 50 mg (n = 95); 5000 IU hCG injections twice weekly (n = 94); or a combination of both therapies (CC + hCG; n = 94). All participants had complete medical history and had undergone thorough physical examination, including body mass index (BMI) assessment. Laboratory tests included serum total testosterone and glycated haemoglobin (HbA1c) measurements. Quantitative Androgen Deficiency in the Aging Male (qADAM) questionnaire scores were also recorded. Morning samples of total serum testosterone levels were assessed at three time points: baseline, 1 and 3 months. RESULTS: Testosterone levels increased at 1 and 3 months in all three groups. The mean baseline testosterone level was 2.31 ± 0.66 nmol/L, BMI was 30.8 ± 6.2 kg/m2 , and qADAM score was 20.5 ± 3.8. Testosterone levels increased in all groups at all time points, with a final mean value of 5.17 ± 1.77 nmol/L (223% increase) with no statistically significant difference among the groups. qADAM scores had increased in all groups at 1 month (CC group: 6.36; hCG group: 5.08; CC + hCG group: 7.26) and at 3 months (CC group: 12.73; hCG group: 11.82; CC + hCG group: 15.13) with a significant difference in intergroup analysis for the CC + hCG group compared with the other two groups (P < 0.01). CONCLUSIONS: All three treatments were equally effective in restoring testosterone levels. Single-agent CC is simple, cheap and may be used as treatment for hypogonadism when maintenance of fertility is desired. This approach seems to be as effective as either hCG alone or a combination of hCG and CC.

Urologists' attitudes to sexual complications of LUTS/BPH treatments.

INTRODUCTION: Many LUTS/BPH treatments currently available may affect sexual function (SD). We wished to assess urologists' attitude and practice in this area. METHODS: Attendees of an international meeting were randomly selected, interviewed and stratified by professional status and LUTS/BPH cases seen per month. There were four questions: treatment options offered, frequency of discussing erectile dysfunction (ED) with each treatment, frequency of discussing ejaculatory dysfunction (EjD) with each treatment, and offering alternative treatment based on the risks of sexual dysfunction. RESULTS: 199 of the 245 interviewed (81%) were urologists. The most common treatments offered were α-blockers (99.5%), 5-ARI (95.0%) and TURP (92.5%). About 70% of the specialists discuss ED before α-blockers (not known to cause ED). Regarding EjD, 70% discuss this prior to prescribing α-blockers, 60% before 5-ARI therapy, while 80% before TURP. A significant minority fails to discuss this complication in all areas. Many respondents do not routinely discuss alternative therapies on the risk of SD. The higher the caseload, the less likely was a urologist to offer alternative therapies, with 37% of urologists seeing over 30 LUTS/BPH patients per month stating they would "Not at all often" offer alternative therapies for this reason. CONCLUSIONS: There is a significant discrepancy in attitudes to counselling patients on SD related to LUTS/BPH treatments. This may, in some cases, affect the validity of consent to the treatment. Most urologists do not discuss alternative treatments with patients based on the risks of different outcomes and complications, and this seems more marked in those with the busier practices. This may sit ill with the concept of personalised healthcare.

Pathological Concordance between Prostate Biopsies and Radical Prostatectomy Using Transperineal Sector Mapping Biopsies: Validation and Comparison with Transrectal Biopsies.

Background/Aims/Objectives: Our aim was to evaluate the accuracy of systematic transperineal sector mapping biopsy (TPSMB) in predicting Gleason score (GS) at radical prostatectomy (RP), to compare its accuracy with standard transrectal ultrasound-guided biopsies (TRUS) and to establish the clinical impact of discordance between biopsies and RP on subsequent surgical management. METHODS: Two hundred fifty-five patients from 2008 to 2013 who underwent RP following TPSMB (n = 204) or TRUS (n = 51), were included in this retrospective multi-institutional study. Concordance between biopsies and RPs GS was assessed both as percentages and with Cohen's Kappa coefficient. All mismatches between biopsies and RP were assessed for significance by 3 urologists using the Delphi method. RESULTS: No differences were present among the groups. Concordance between biopsy and RP GS was 75.49% for TPSMB and 64.70% for TRUS. Kappa coefficient was 0.42 and 0.39 respectively. The Delphi method showed lower clinical impact of GS discordances for TPSMB with 7.8% of patients having significant change, thus being potentially more suitable for other treatment modalities, compared to TRUS (13.7%). CONCLUSIONS: TPSMB had a higher accuracy for predicting the GS grade at RP showing superior GS concordance compared with standard TRUS. TPSMB provides an effective technique for systematic prostate biopsy to evaluate overall prostate cancer GS.

Systematic review of lower urinary tract symptoms/benign prostatic hyperplasia surgical treatments on men's ejaculatory function: Time for a bespoke approach?

Although ejaculatory dysfunction is common for patients undergoing benign prostatic hyperplasia surgery, no clear evidence is present to counsel men seeking to preserve ejaculation. Our aim was to evaluate ejaculatory dysfunction in relation to benign prostatic hyperplasia surgery. We carried out a web and manual search using MEDLINE and Embase including randomized controlled trials reporting ejaculatory dysfunction after benign prostatic hyperplasia surgery: 42 randomized controlled trials comprising a total of 3857 patients were included. Only one study had ejaculatory dysfunction as a primary outcome, and just 10 evaluated ejaculatory dysfunction before and after surgery. The definition of ejaculatory dysfunction was not standardized. Similarly, just seven studies used internationally validated questionnaires to address ejaculatory dysfunction. The reported rates of ejaculatory dysfunction after resectional electrosurgery, laser procedures, coagulation, ablation and implant techniques were assessed and compared. Transurethral resection of the prostate and recent laser procedures including holmium, thulium and GreenLight cause similar rates of ejaculatory dysfunction, occurring in almost three out of four to five men. Although providing less symptomatic benefit compared with transurethral resection of the prostate, transurethral incision of the prostate, transurethral needle ablation and transurethral microwave thermotherapy should be considered for men aiming to maintain normal ejaculation. UroLift is also a recent promising option for this category of patients. The vast majority of studies reporting ejaculatory dysfunction after benign prostatic hyperplasia surgery used poor methodology to investigate this complication. Future studies able to address clear hypothesis and considering ejaculatory dysfunction anatomical and pathophysiological features are required to develop ejaculation preserving techniques and to increase the evidence to counsel men aiming to preserve ejaculation.

A European multicenter randomized noninferiority trial comparing 180 W GreenLight XPS laser vaporization and transurethral resection of the prostate for the treatment of benign prostatic obstruction: 12-month results of the GOLIATH study.

PURPOSE: We present the 1-year results of the GOLIATH prospective randomized controlled trial comparing transurethral resection of the prostate to GreenLight XPS for the treatment of men with nonneurogenic lower urinary tract symptoms due to prostate enlargement. The updated results at 1 year show that transurethral resection of the prostate and GreenLight XPS remain equivalent, and confirm the therapeutic durability of both procedures. We also report 1-year followup data from several functional questionnaires (OABq-SF, ICIQ-SF and IIEF-5) and objective assessments. MATERIALS AND METHODS: A total of 291 patients were enrolled at 29 sites in 9 European countries. Patients were randomized 1:1 to undergo GreenLight XPS or transurethral resection of the prostate. The trial was designed to evaluate the hypothesis that GreenLight XPS is noninferior to transurethral resection of the prostate on the International Prostate Symptom Score at 6 months. Several objective parameters were assessed, including maximum urinary flow rate, post-void residual urine volume, prostate volume and prostate specific antigen, in addition to functional questionnaires and adverse events at each followup. RESULTS: Of the 291 enrolled patients 281 were randomized and 269 received treatment. Noninferiority of GreenLight XPS was maintained at 12 months. Maximum urinary flow rate, post-void residual urine volume, prostate volume and prostate specific antigen were not statistically different between the treatment arms at 12 months. The complication-free rate at 1 year was 84.6% after GreenLight XPS vs 80.5% after transurethral resection of the prostate. At 12 months 4 patients treated with GreenLight XPS and 4 who underwent transurethral resection of the prostate had unresolved urinary incontinence. CONCLUSIONS: Followup at 1 year demonstrated that photoselective vaporization of the prostate produced efficacy outcomes similar to those of transurethral resection of the prostate. The complication-free rates and overall reintervention rates were comparable between the treatment groups.

Am I normal? A systematic review and construction of nomograms for flaccid and erect penis length and circumference in up to 15,521 men.

OBJECTIVE: To systematically review and create nomograms of flaccid and erect penile size measurements. METHODS: Study key eligibility criteria: measurement of penis size by a health professional using a standard procedure; a minimum of 50 participants per sample. EXCLUSION CRITERIA: samples with a congenital or acquired penile abnormality, previous surgery, complaint of small penis size or erectile dysfunction. Synthesis methods: calculation of a weighted mean and pooled standard deviation (SD) and simulation of 20,000 observations from the normal distribution to generate nomograms of penis size. RESULTS: Nomograms for flaccid pendulous [n = 10,704, mean (SD) 9.16 (1.57) cm] and stretched length [n = 14,160, mean (SD) 13.24 (1.89) cm], erect length [n = 692, mean (SD) 13.12 (1.66) cm], flaccid circumference [n = 9407, mean (SD) 9.31 (0.90) cm], and erect circumference [n = 381, mean (SD) 11.66 (1.10) cm] were constructed. Consistent and strongest significant correlation was between flaccid stretched or erect length and height, which ranged from r = 0.2 to 0.6. LIMITATIONS: relatively few erect measurements were conducted in a clinical setting and the greatest variability between studies was seen with flaccid stretched length. CONCLUSIONS: Penis size nomograms may be useful in clinical and therapeutic settings to counsel men and for academic research.

Validation of the GreenLight™ Simulator and development of a training curriculum for photoselective vaporisation of the prostate.

OBJECTIVES: To assess face, content and construct validity, and feasibility and acceptability of the GreenLight™ Simulator as a training tool for photoselective vaporisation of the prostate (PVP), and to establish learning curves and develop an evidence-based training curriculum. SUBJECTS AND METHODS: This prospective, observational and comparative study, recruited novice (25 participants), intermediate (14) and expert-level urologists (seven) from the UK and Europe at the 28th European Association of Urological Surgeons Annual Meeting 2013. A group of novices (12 participants) performed 10 sessions of subtask training modules followed by a long operative case, whereas a second group (13) performed five sessions of a given case module. Intermediate and expert groups performed all training modules once, followed by one operative case. The outcome measures for learning curves and construct validity were time to task, coagulation time, vaporisation time, average sweep speed, average laser distance, blood loss, operative errors, and instrument cost. Face and content validity, feasibility and acceptability were addressed through a quantitative survey. RESULTS: Construct validity was demonstrated in two of five training modules (P = 0.038; P = 0.018) and in a considerable number of case metrics (P = 0.034). Learning curves were seen in all five training modules (P < 0.001) and significant reduction in case operative time (P < 0.001) and error (P = 0.017) were seen. An evidence-based training curriculum, to help trainees acquire transferable skills, was produced using the results. CONCLUSION: This study has shown the GreenLight Simulator to be a valid and useful training tool for PVP. It is hoped that by using the training curriculum for the GreenLight Simulator, novice trainees can acquire skills and knowledge to a predetermined level of proficiency.

Determination of optimal drug dose and light dose index to achieve minimally invasive focal ablation of localised prostate cancer using WST11-vascular-targeted photodynamic (VTP) therapy.

OBJECTIVE: To determine the optimal drug and light dose for prostate ablation using WST11 (TOOKAD Soluble) for vascular-targeted photodynamic (VTP) therapy in men with low-risk prostate cancer. PATIENTS AND METHODS: In all, 42 men with low-risk prostate cancer were enrolled in the study but two who underwent anaesthesia for the procedure did not receive the drug or light dose. Thus, 40 men received a single dose of 2, 4 or 6 mg/kg WST11 activated by 200 J/cm light at 753 nm. WST11 was given as a 10-min intravenous infusion. The light dose was delivered using cylindrical diffusing fibres within hollow plastic needles positioned in the prostate using transrectal ultrasonography (TRUS) guidance and a brachytherapy template. Magnetic resonance imaging (MRI) was used to assess treatment effect at 7 days, with assessment of urinary function (International Prostate Symptom Score [IPSS]), sexual function (International Index of Erectile Function [IIEF]) and adverse events at 7 days, 1, 3 and 6 months after VTP. TRUS-guided biopsies were taken at 6 months. RESULTS: In all, 39 of the 40 treated men completed the follow-up. The Day-7 MRI showed maximal treatment effect (95% of the planned treatment volume) in men who had a WST11 dose of 4 mg/kg, light dose of 200 J/cm and light density index (LDI) of >1. In the 12 men treated with these parameters, the negative biopsy rate was 10/12 (83%) at 6 months, compared with 10/26 (45%) for the men who had either a different drug dose (10 men) or an LDI of <1 (16). Transient urinary symptoms were seen in most of the men, with no significant difference in IPSS score between baseline and 6 months after VTP. IIEF scores were not significantly different between baseline and 6 months after VTP. CONCLUSION: Treatment with 4 mg/kg TOOKAD Soluble activated by 753 nm light at a dose of 200 J/cm and an LDI of >1 resulted in treatment effect in 95% of the planned treatment volume and a negative biopsy rate at 6 months of 10/12 men (83%).

Analysis of the Interobserver Variability in Penile Length Assessment.

INTRODUCTION: Many men seek penile augmentation treatments-a standard tool for their counseling is to inform them of what is "normal." Although some studies suggest good correlation between stretched and erect penile length, those that have measured stretched and erect length simultaneously have shown significant variability. AIM: To assess the accuracy of differing penile measurements with multiple observers. METHODS: We recruited 201 adult men (mean age 49.6 years) who achieved full erection using intracavernosal injection. MAIN OUTCOME MEASURES: Penile measurements were taken by one of seven andrology specialists in a private, temperature-controlled (21°C, 72°F) environment. Stretched flaccid and erect length and circumference were measured. We analyzed the accuracy of each flaccid measurement using the erect measurements as a reference, for the overall patient population and for each observer. RESULTS: The mean underestimate of length from stretched flaccid to erect was 2.64 cm (21.4%) and girth 2.27 cm (19.5%). Interobserver variability ranged from a mean underestimate of 16-27% (length) and 15-27% (girth). CONCLUSIONS: In this large, multicenter, multi-observer study of penis size, flaccid measurements underestimated erect size. It also seems likely that there is significant interobserver variability. We believe erect penis measurements should be used for men being considered for treatment of small penis anxiety.

Erect penile dimensions in a cohort of 778 Middle Eastern men: establishment of a nomogram.

INTRODUCTION: Accurate data regarding the size of the erect penis are of great importance to several disciplines working with male patients, but little high-quality research exists on the subject, particularly in different ethnic groups and for erect penis size. AIM: The aim of this study was to create a nomogram of erect penile dimensions in a large sample of Middle Eastern men. METHODS: A retrospective cohort study of 778 men (mean age 43.7; range 20-82) attending urological outpatient clinics in Saudi Arabia was conducted. Exclusion criteria were age under 18 years, a presenting complaint of small or short penis, Peyronie's disease or complaint of congenital curvature, clinical hypogonadism, and previous penile surgery or trauma. MAIN OUTCOME MEASURES: Three erect penile dimensions following induction of erection using intracavernosal injection of Quadrimix. RESULTS: Mean patient body mass index (BMI) was 29.09 (standard deviation [SD] 5.76). The mean suprapubic skin-to-penile tip erect length was 12.53 cm (SD 1.93); the mean erect length from the symphysis pubis to the penile tip was 14.34 cm (SD 1.86); and the mean erect shaft circumference was 11.50 cm (SD 1.74). A nomogram was constructed and statistical analysis performed, demonstrating a weak negative correlation between BMI and erect penile length measured from the suprapubic skin (r = -0.283, P < 0.000) but not from bone to tip, and a weak negative correlation between age and both erect penile length measurements (skin to tip r = -0.177, P < 0.0005; bone to tip r = -0.099, P = 0.006). CONCLUSION: A nomogram for Middle Eastern men can be used as a standard when advising men with small penis anxiety. The importance of measuring erect size and allowing for infra-pubic fat interference in measurement is emphasized. We envisage that this tool can be used to educate and reassure concerned men about the size of their penises.

Penile Dysmorphic Disorder: Development of a Screening Scale.

Penile dysmorphic disorder (PDD) is shorthand for men diagnosed with body dysmorphic disorder, in whom the size or shape of the penis is their main, if not their exclusive, preoccupation causing significant shame or handicap. There are no specific measures for identifying men with PDD compared to men who are anxious about the size of their penis but do not have PDD. Such a measure might be helpful for treatment planning, reducing unrealistic expectations, and measuring outcome after any psychological or physical intervention. Our aim was, therefore, to validate a specific measure, termed the Cosmetic Procedure Screening Scale for PDD (COPS-P). Eighty-one male participants were divided into three groups: a PDD group (n = 21), a small penis anxiety group (n = 37), and a control group (n = 23). All participants completed the COPS-P as well as standardized measures of depression, anxiety, social phobia, body image, quality of life, and erectile function. Penis size was also measured. The final COPS-P was based on nine items. The scale had good internal reliability and significant convergent validity with measures of related constructs. It discriminated between the PDD group, the small penis anxiety group, and the control group. This is the first study to develop a scale able to discriminate between those with PDD and men anxious about their size who did not have PDD. Clinicians and researchers may use the scale as part of an assessment for men presenting with anxiety about penis size and as an audit or outcome measure after any intervention for this population.

Beliefs about penis size: validation of a scale for men ashamed about their penis size.

INTRODUCTION: No measures are available for understanding beliefs in men who experience shame about the perceived size of their penis. Such a measure might be helpful for treatment planning, and measuring outcome after any psychological or physical intervention. AIM: Our aim was to validate a newly developed measure called the Beliefs about Penis Size Scale (BAPS). METHOD: One hundred seventy-three male participants completed a new questionnaire consisting of 18 items to be validated and developed into the BAPS, as well as various other standardized measures. A urologist also measured actual penis size. MAIN OUTCOME MEASURES: The BAPS was validated against six psychosexual self-report questionnaires as well as penile size measurements. RESULTS: Exploratory factor analysis reduced the number of items in the BAPS from 18 to 10, which was best explained by one factor. The 10-item BAPS had good internal consistency and correlated significantly with measures of depression, anxiety, body image quality of life, social anxiety, erectile function, overall satisfaction, and the importance attached to penis size. The BAPS was not found to correlate with actual penis size. It was able to discriminate between those who had concerns or were dissatisfied about their penis size and those who were not. CONCLUSIONS: This is the first study to develop a scale for measurement of beliefs about penis size. It may be used as part of an assessment for men who experience shame about the perceived size of their penis and as an outcome measure after treatment. The BAPS measures various manifestations of masculinity and shame about their perceived penis size including internal self-evaluative beliefs; negative evaluation by others; anticipated consequences of a perceived small penis, and extreme self-consciousness.

Investigating the risk factors of penile arterial insufficiency and veno-occlusive dysfunction in patients with erectile dysfunction.

Objective: To investigate the risk factors for penile arterial insufficiency (PAI), which is a known cause of erectile dysfunction (ED). Methods: Patients who attended our urology clinic complaining of ED for more than 6 months were prospectively enrolled in this study over 1-year period. Patient consent was taken and ethical committee approval. Complete medical history and thorough general and local examination including body mass index (BMI), Peyronie's disease (PD) and penile size measurements (length and girth) were done for all of them. Laboratory tests included testosterone, lipid profile and glycated haemoglobin (HA1c). A penile duplex ultrasound study (PDU) was done for all patients after intracavernosal injection (ICI) with alprostadil. Peak systolic velocity (PSV) and end-diastolic velocity (EDV) were measured after 15 min. Statistical analysis was done using SPSS. Results: A total of 440 patients were enrolled in this analysis. The mean age was 48(23-81), and the mean BMI was 30 (18-51). Older patients had lower PSV (r = -0.361, P = 0.000) and higher EDV (r = 0.174, P = 0.001), and both correlations were highly statistically significant. Diabetics had lower PSV (r = -0.318, P = 0.000) and higher EDV (r = 0.139, P = 0.008), which were also highly statistically significant. Smokers had lower PSV (r = -0.140, P = 0.008) and higher EDV (r = 0.178, P = 0.001), which were highly statistically significant. Men with larger penises measured skin to tip had lower EDV (r = -0.119, P = 0.024), which was less significant. Interestingly, there was neither a significant correlation between BMI and PSV (0.16, P = 0.745) nor a significant correlation between testosterone and PSV (0.029, P = 0.552). Also, there was no correlation between PSV and both dyslipidaemia and penile PD. Conclusions: Ageing, tobacco consumption, DM and hypertension seem to have a negative impact on penile haemodynamics, which was statistically significant. In our patients, there was no statistically significant effect on penile haemodynamics in patients with increased BMI, low testosterone or PD or according to the size of the penis.

TOOKAD(®) Soluble vascular-targeted photodynamic (VTP) therapy: determination of optimal treatment conditions and assessment of effects in patients with localised prostate cancer.

OBJECTIVES: To evaluate the optimal treatment conditions and effects of TOOKAD(®) Soluble vascular-targeted photodynamic (VTP) therapy in patients with localised prostate cancer. To evaluate the safety and quality of life after TOOKAD(®) Soluble VTP treatment in patients with localised prostate cancer. PATIENTS AND METHODS: Men (aged >18 years) diagnosed with localised prostate cancer, who were suitable for active surveillance, were invited to take part in the study. Patients who had received prior or current treatment for their cancer were excluded. There were two parts to the study: in part one, patients were assigned to one of two treatment groups based on the size of their prostates (patients with prostate size <60 mL would receive 4 mg/kg TOOKAD(®) Soluble and patients with prostate size ≥60 mL would receive 6 mg/kg TOOKAD(®) Soluble both activated with 200 J/cm light). In part two, patients were assigned to one of two treatment groups based on predefined criteria and received either 4 or 6 mg/kg TOOKAD(®) Soluble and 200 or 300 J/cm light. VTP was conducted under general anaesthesia using TOOKAD(®) Soluble administered intravenously and activated by light-diffusing fibres within the prostate via the perineum. Follow-up was conducted for 6 months. Magnetic resonance imaging (MRI) carried out at 1 week after VTP and transrectal prostate biopsy at 6 months were the key endpoints. Adverse event (AE) recording and patient-reported outcome measures were collected. RESULTS: In all, 86 patients were enrolled in the study and 85 patients received treatment. Of the 85 treated patients, one patient discontinued (due to withdrawal of consent). At 6 months, 61/83 (74%) patients who underwent prostate biopsy had histopathology that was negative for prostate cancer (95% confidence interval (CI) 62.7-82.6%). Considering patients who received 4 mg/kg TOOKAD(®) Soluble and 200 J/cm light (unilateral), which are considered optimal treatment parameters, 38/46 (83%) patients had histopathology from the biopsies that was negative for prostate cancer at 6 months (95% CI 68.6-92.2%; P < 0.001). The mean percentage of necrosis of the targeted prostate tissue at 7 days after VTP was 78% overall (83 patients) with extraprostatic necrosis reported in 76% (63/83) of patients. Considering patients who received 4 mg/kg TOOKAD(®) Soluble and 200 J/cm light (unilateral), the mean 7-day necrosis percentage was 88% (46 patients) with extraprostatic necrosis reported in 72% (33/46) of patients. All occurrences of extraprostatic necrosis were considered clinically acceptable and none were associated with any clinical sequelae. The mean percentage prostate necrosis at 7 days was statistically significantly higher (P < 0.001) in patients treated with a therapeutic light density index (LDI) of ≥1 than those treated with a LDI of <1. The percentage of patients with negative biopsies at 6 months was also higher in patients treated with a therapeutic LDI of ≥1 than those treated with a LDI of <1 (78.6% and 63.0%, respectively). In all, 87% (75/86) of patients reported at least one treatment-emergent AE during the study. Most AEs were mild or moderate in intensity and considered related to the technical procedures of the study. No treated patients had hypotension or discontinued due to AEs. Eight patients (9.3%) had serious AEs; none resulted in discontinuation from the study. CONCLUSIONS: Biopsy data, post-treatment dynamic contrast-enhancement MRI at 1 week after VTP and analysis of the safety data have shown that 4 mg/kg TOOKAD(®) Soluble and 200 J/cm light are the optimal treatment conditions for the VTP procedure resulting in >80% of patients treated with this regimen having a negative biopsy at 6 months. Overall, the treatment was well tolerated and exhibited early signs of efficacy for minimally invasive focal treatment of localised prostate cancer.

Definitions of terms, processes and a minimum dataset for transperineal prostate biopsies: a standardization approach of the Ginsburg Study Group for Enhanced Prostate Diagnostics.

OBJECTIVES: To define terms and processes and agree on a minimum dataset in relation to transperineal prostate biopsy procedures and enhanced prostate diagnostics. To identify the need for further evaluation and establish a collaborative research practice. PATIENTS AND METHODS: A 19-member multidisciplinary panel rated 66 items for their appropriateness and their definition to be incorporated into the international databank using the Research and Development/University of California Los Angeles Appropriateness Method. The item list was developed from interviews conducted with healthcare professionals from urology, radiology, pathology and engineering. RESULTS: The panel agreed on 56 items that were appropriate to be incorporated into a prospective database. In total, 10 items were uncertain and were omitted. These items were within the categories: definitions (n = 2), imaging (n = 1), surgical protocols (n = 2) and histology (n = 5). CONCLUSIONS: The components of a minimum dataset for transperineal prostate biopsy have been defined. This provides an opportunity for multicentre collaborative data analysis and technique development. The findings of the present study will facilitate prospective studies into the application and outcome of transperineal prostate biopsies.

Hyperbolic source location of crack related acoustic emission in bone.

Little work has been done on the localization of microcracks in bone using acoustic emission. Microcrack localization is useful to study the fracture process in bone and to prevent fractures in patients. Locating microcracks that occur before fracture allows one to predict where fracture will occur if continued stress is applied to the bone. Two source location algorithms were developed to locate microcracks on rectangular bovine bone samples. The first algorithm uses a constant velocity approach which has some difficulty dealing with the anisotropic nature of bone. However, the second algorithm uses an iterative technique to estimate the correct velocity for the acoustic emission source location being located. In tests with simulated microcracks, the constant velocity algorithm achieves a median error of 1.78 mm (IQR 1.51 mm) and the variable velocity algorithm improves this to a median error of 0.70 mm (IQR 0.79 mm). An experiment in which the bone samples were loaded in a three point bend test until they fractured showed a good correlation between the computed location of detected microcracks and where the final fracture occurred. Microcracks can be located on bovine bone samples using acoustic emission with good accuracy and precision.

What is the medical evidence on non-therapeutic child circumcision?

Non-therapeutic circumcision refers to the surgical removal of part or all of the foreskin, in healthy males, where there is no medical condition requiring surgery. The arguments for and against this practice in children have been debated for many years, with conflicting and conflicted evidence presented on both sides. Here, we explore the evidence behind the claimed benefits and risks from a medical and health-related perspective. We examine the number of circumcisions which would be required to achieve each purported benefit, and set that against the reported rates of short- and long-term complications. We conclude that non-therapeutic circumcision performed on otherwise healthy infants or children has little or no high-quality medical evidence to support its overall benefit. Moreover, it is associated with rare but avoidable harm and even occasional deaths. From the perspective of the individual boy, there is no medical justification for performing a circumcision prior to an age that he can assess the known risks and potential benefits, and choose to give or withhold informed consent himself. We feel that the evidence presented in this review is essential information for all parents and practitioners considering non-therapeutic circumcisions on otherwise healthy infants and children.