Evaluation of the visual prostate symptom score in a male population with great language diversity and limited education: a study from Namibia.

BACKGROUND: A visual prostate symptom score (VPSS) using pictograms was developed to assess the force of the urinary stream, urinary frequency, nocturia and quality of life (QoL). OBJECTIVE: To compare the VPSS with the international prostate symptom score (IPSS) and maximum (Qmax) and average (Qave) urinary flow rates in men from diverse language groups with limited schooling. METHODS: Men with lower urinary tract symptoms admitted to the urology ward at Windhoek Central Hospital, Namibia, were evaluated. Patients who were unable to complete the questionnaires alone were assisted by a doctor or nurse. Local ethics committee approval was obtained. Statistical analysis was performed using Student's t-test and Spearman's rank correlation test. RESULTS: One hundred men (mean age 56.3 years, range 20.1 - 95.4) were evaluated over a period of one year. All the men understood one or more of 15 languages, and 30 were illiterate; 32 had <5 years of schooling, 34 had 5 - 9 years and 34 had >9 years. The VPSS took significantly less time to complete than the IPSS. There were statistically significant correlations between the total VPSS and IPSS scores, between the four VPSS questions and the corresponding IPSS questions, and between Qmax and Qave and the VPSS total and VPSS questions on the force of the urinary stream and QoL. CONCLUSION: The VPSS pictograms depicting the force of the urinary stream and QoL correlated significantly with Qmax and Qave, indicating that they can be used as single-item questions to rapidly assess bladder outflow obstruction in men with limited education.

Clinical (non-histological) diagnosis of advanced prostate cancer: Evaluation of treatment outcome after androgen deprivation therapy.

Introduction. Transrectal biopsy in suspected adenocarcinoma of the prostate (ACP) may cause significant morbidity and even mortality. A strong association between serum prostate-specific antigen (PSA) and tumour burden exists. If biopsy can be avoided in advanced disease, much morbidity and cost may be saved.Objective. To evaluate the reliability of using PSA and clinical features to establish a non-histological diagnosis of ACP.Methods. Androgen deprivation therapy (ADT) was used in 825 (56.2%) of 1 467 men with ACP. The diagnosis of ACP was made histologically in 607 patients (73.6%) and clinically alone in 218 (26.4%), based on a serum PSA level of >60 ng/ml, and/or clinical evidence of a T3 - T4 tumour on digital rectal examination, and/or imaging evidence of metastases. We compared two randomly selected groups treated with bilateral orchidectomy (BO) based on a clinical-only (n=90) v. histological (n=96) diagnosis of ACP.Results. There was no significant difference between the groups with regard to mean follow-up (26.1 v. 26.8 months), documented PSA relapse (70% v. 67.7%), and patients alive at last follow-up (91.1% v. 95.8%). ZAR1 068 200 (US$1 = ZAR8) was saved by treating men with advanced ACP on the basis of a clinical (non-histological) diagnosis only, and a total of ZAR24 321 000 was saved by using BO instead of luteinising hormone-releasing hormone agonists as ADT.Conclusion. A reliable clinical (non-histological) diagnosis of advanced ACP can be made based on serum PSA and clinical features. This avoids the discomfort and potentially serious complications of biopsy and saves cost.

SIU/ICUD Consultation on Urethral Strictures: Dilation, internal urethrotomy, and stenting of male anterior urethral strictures.

Male urethral stricture is one of the oldest known urologic diseases, and continues to be a common and challenging urologic condition. Our objective was to review all contemporary and historial articles on the topic of dilation, internal urethrotomy, and stenting of male anterior urethral strictures. An extensive review of the scientific literature concerning anterior urethral urethrotomy/dilation/stenting was performed. Articles were included that met the criteria set by the International Consultation on Urological Diseases (ICUD) urethral strictures committee and were classified by level of evidence using the Oxford Centre for Evidence-Based Medicine criteria adapted from the work of the Agency for Health Care Policy and Research as modified for use in previous ICUD projects. Using criteria set forth by the ICUD, a committee of international experts in urethral stricture disease reviewed the literature and created a consensus statement incorporating levels of evidence and expert opinion in regard to dilation, internal urethrotomy, and stenting of male anterior urethral strictures.

Prospective evaluation of a new visual prostate symptom score, the international prostate symptom score, and uroflowmetry in men with urethral stricture disease.

OBJECTIVE: To evaluate the correlation between the visual prostate symptom score (VPSS) and the international prostate symptom score (IPSS) and uroflowmetry parameters in men with urethral stricture disease. The VPSS offers a nonverbal, pictographic assessment of lower urinary tract symptoms. METHODS: A total of 100 men followed up with a diagnosis of urethral stricture were evaluated from March 2011 to November 2012 with IPSS, VPSS, uroflowmetry, urethral calibration, and urethrography. Follow-up every 3 months for 3-18 months was available in 78 men for a total of 289 visits. Procedures performed were urethral dilation in 105, internal urethrotomy in 54, and urethroplasty in 8 patients. Statistical analysis was performed with Spearman's rank correlation, Fisher's exact, and Student t tests. RESULTS: The time taken to complete the VPSS vs IPSS was significantly shorter (118 vs 215 seconds at the first and 80 vs 156 seconds at follow-up visits; P <.001). There were significant correlations between the VPSS and IPSS (r = 0.845; P <.001), maximum urinary flow rate (Qmax; r = 0.681; P <.001) and urethral diameter (r = -0.552; P <.001). A combination of VPSS >8 and Qmax <15 mL/s had positive and negative predictive values of 87% and 89%, respectively, for the presence of urethral stricture. CONCLUSION: The VPSS correlates significantly with the IPSS, Qmax, and urethral diameter in men with urethral stricture disease and takes significantly less time to complete. A combination of VPSS >8 and Qmax <15 mL/s can be used to avoid further invasive evaluation during follow-up in men with urethral strictures.

Urological aspects of HIV and AIDS.

The use of highly active antiretroviral therapy (HAART) in HIV-infected people has led to a dramatic decrease in the incidence of opportunistic infections and virus-related malignancies such as non-Hodgkin lymphoma and Kaposi sarcoma, but not cervical or anal cancer. Advanced-stage cervical cancer is associated with a high incidence of urological complications such as hydronephrosis, renal failure, and vesicovaginal fistula. Adult male circumcison can significantly reduce the risk of male HIV acquisition. Although HAART does not completely eradicate HIV, compliance with medication increases life expectancy. HIV infection or treatment can result in renal failure, which can be managed with dialysis and transplantation (as for HIV-negative patients). Although treatment for erectile dysfunction--including phosphodiesterase 5 inhibitors, intracavernosal injection therapy, and penile prosthesis--can increase the risk of HIV transmission, treatment decisions for men with erectile dysfunction should not be determined by HIV status. The challenges faced when administering chemotherapy to HIV-infected patients with cancer include late presentation, immunodeficiency, drug interactions, and adverse effects associated with compounded medications. Nonetheless, HIV-infected patients should receive the same cancer treatment as HIV-negative patients. The urologist is increasingly likely to encounter HIV-positive patients who present with the same urological problems as the general population, because HAART confers a prolonged life expectancy. Performing surgery in an HIV-infected individual raises safety issues for both the patient (if severely immunocompromised) and the surgeon, but the risk of HIV transmission from patients on fully suppressive HAART is small.

Global patterns of prostate cancer incidence, aggressiveness, and mortality in men of african descent.

Prostate cancer (CaP) is the leading cancer among men of African descent in the USA, Caribbean, and Sub-Saharan Africa (SSA). The estimated number of CaP deaths in SSA during 2008 was more than five times that among African Americans and is expected to double in Africa by 2030. We summarize publicly available CaP data and collected data from the men of African descent and Carcinoma of the Prostate (MADCaP) Consortium and the African Caribbean Cancer Consortium (AC3) to evaluate CaP incidence and mortality in men of African descent worldwide. CaP incidence and mortality are highest in men of African descent in the USA and the Caribbean. Tumor stage and grade were highest in SSA. We report a higher proportion of T1 stage prostate tumors in countries with greater percent gross domestic product spent on health care and physicians per 100,000 persons. We also observed that regions with a higher proportion of advanced tumors reported lower mortality rates. This finding suggests that CaP is underdiagnosed and/or underreported in SSA men. Nonetheless, CaP incidence and mortality represent a significant public health problem in men of African descent around the world.

Disintegrating Perineal Disease in Patients with Urethral Stricture and HIV Infection: A Review of 12 Cases

The aim of this study was to define disintegrating perineal disease (DPD) and to determine whether the fulminating nature of the condition could be explained by urine and perineal swab microbiology or perineal histology. A retrospective study that included 12 male patients with urethral strictures and DPD was performed. DPD was defined as a chronic; destructive; purulent perineal inflammation with multiple fistulae or sinuses of the perineum; scrotum or penoscrotal area; which continued for more than six weeks despite a patent urethra after direct vision internal urethrotomy (DVIU) or urinary diversion by means of suprapubic cystostomy. The median patient age was 43.5 years (range of 22-68 years). The patients all tested positive for human immunodeficiency virus (HIV) infection. Their mean CD4 count was 340 cells/mm3 (range of 244-1 252 cells/mm3). Histology of the fistula tracts showed non-specific inflammation in 8 patients (66.7); tuberculosis in 2 (16.7); hydradenitis suppurativa in one (8.3); and squamous cell carcinoma in situ with condylomata acuminata in one patient (8.3). DVIU was performed in 10 patients. Patency of the urethra could be achieved in only three patients for more than six weeks. Perineal urethrostomy was completed in three patients after failed DVIU. Ileal conduit urinary diversion and simple cystectomy was carried out in three patients and curing the DPD was accomplished in two. DPD relates to urethral stricture disease in HIV-positive men with secondary infection as the initiating cause; but no predominant microorganism is responsible for the condition. Simple cystectomy with urinary diversion may be the only solution to treating this debilitating disease

Prevalence of histological prostatitis in men with benign prostatic hyperplasia or adenocarcinoma of the prostate presenting without urinary retention.

OBJECTIVE: To determine the prevalence of prostatitis on histopathological evaluation of prostatic tissue in men without urinary retention. DESIGN, SETTING AND SUBJECTS: The clinical data and histopathology reports of men seen from January 1999 through March 2009 at our institution were analysed using Student's t-test, the Mann-Whitney test and Fisher's exact test where appropriate. Values were expressed as means, medians and ranges (p<0.05 accepted as statistically significant). OUTCOME MEASURES: Data collected included patient age, duration of lower urinary tract symptoms and hospitalisation, findings on digital rectal examination, prostate volume, haemoglobin concentration, serum creatinine and prostate-specific antigen (PSA) levels, and histological findings. RESULTS: Prostatic tissue of 385 men without urinary retention at presentation was obtained via biopsy (48.3% of cases), transurethral prostatectomy (62.9%), retropubic prostatectomy (6.8%) or radical prostatectomy (28.3%). On histological examination, benign prostatic hyperplasia (BPH) was found to be present in 213 patients (55.3%) and adenocarcinoma of the prostate (ACP) in 172 (44.7%). Histological prostatitis was present in 130 patients (61.0%) with BPH and 51 (29.7%) with ACP (p<0.001). A previous study of 405 men presenting with urinary retention at our institution showed histological prostatitis in 98/204 (48.0%) with BPH and in 51/201 (25.4%) with ACP. The group of men with BPH alone had a significantly lower mean serum PSA at presentation (4.5 ng/ml, range 0.3 - 20.8 ng/ml) compared with the group with BPH and prostatitis (11.2 ng/ml, range 0.2 - 145 ng/ml, p=0.011). The mean PSA level at presentation did not differ significantly between the group with ACP only (40.9 ng/ml, range 0 - 255 ng/ml) and the group with ACP plus prostatitis (1 672 ng/ml, range 0.3 - 38 169 ng/ml, p=0.076). CONCLUSIONS: Among men presenting without urinary retention, histological prostatitis was significantly more prevalent in those with BPH than in those with ACP (61% v. 30%), similar to the previous study of men presenting with retention at our institution, in which histological prostatitis was significantly more prevalent in BPH than in ACP (48% v. 25%). This finding suggests that histological prostatitis is not significantly associated with the causation of ACP or urinary retention. Serum PSA at presentation was significantly higher in the group with BPH plus prostatitis compared with BPH alone, but not in the group with ACP plus prostatitis compared with ACP alone.

Bladder cancer documentation of causes: multilingual questionnaire, 'bladder cancer doc'.

There is a considerable discrepancy between the number of identified occupational-related bladder cancer cases and the estimated numbers particularly in emerging nations or less developed countries where suitable approaches are less or even not known. Thus, within a project of the World Health Organisation Collaborating Centres in Occupational Health, a questionnaire of the Dortmund group, applied in different studies, was translated into more than 30 languages (Afrikaans, Arabic, Bengali, Chinese, Czech, Dutch, English, Finnish, French, Georgian, German, Greek, Hindi, Hungarian, Indonesian, Italian, Japanese, Kannada, Kazakh, Kirghiz, Korean, Latvian, Malay, Persian (Farsi), Polish, Portuguese, Portuguese/Brazilian, Romanian, Russian, Serbo-Croatian, Slovak, Spanish, Spanish/Mexican, Tamil, Telugu, Thai, Turkish, Urdu, Vietnamese). The bipartite questionnaire asks for relevant medical information in the physician's part and for the occupational history since leaving school in the patient's part. Furthermore, this questionnaire is asking for intensity and frequency of certain occupational and non-occupational risk factors. The literature regarding occupations like painter, hairdresser or miner and exposures like carcinogenic aromatic amines, azo dyes, or combustion products is highlighted. The questionnaire is available on www.ifado.de/BladderCancerDoc.

Outcome of dual flange metallic urethral stents in the treatment of neuropathic bladder dysfunction after spinal cord injury.

PURPOSE: To review the results of metallic urethral stents used in patients with neuropathic bladder dysfunction after spinal cord injury (SCI). PATIENTS AND METHODS: In a rehabilitation unit for SCI and stroke in Cape Town, South Africa, we performed a case note review of dual flange Memokath stents placed from March 2008 until October 2011. Stents were placed rather than performing an external sphincterotomy in selected patients. With the patient under deep general anesthesia, a thermosensitive expandable metallic stent was positioned over the internal and external urethral sphincters. RESULTS: In total, 33 stents were placed in 28 male patients. SCI was cervical in 23 patients and thoracic in 5. Average follow-up was 18 months (range 1-40 months, median 18 months). The most common indications were repeated catheter blockage in eight patients and urinary tract infection in six. The average time from SCI to stent insertion was 79 months (range 1-468 months, median 21 months). Severe autonomic dysreflexia was present in 17 cases before stent placement and in 7 after stents were placed (P=0.003). Stents failed in 15 patients (45%) and were removed. The most common reason for failure was stone formation. Comparing the group of patients with stents lasting >20 months (n=11) to the group with stent removal before 20 months (n=10), the mean time between SCI and stent placement was 31 vs 119 months (P=0.057). Medium term results (up to 27 months) were significantly influenced by earlier stent placement (P=0.0484). One major complication was stent migration that caused an urethrocutaneous fistula.

Inflammatory myofibroblastic tumor of the bladder in a 3-year-old boy.

Inflammatory myofibroblastic tumor (IMT) is a rare neoplasm with unknown malignant potential that has been described in most organ systems. We present the case of a 3-year-old boy who was referred with lower urinary tract symptoms and macroscopic hematuria. An IMT was suspected after clinical, radiological, and surgical work-up, and the diagnosis was confirmed after a partial cystectomy was performed. A bladder-preserving approach is the treatment of choice, but close clinical follow-up is recommended because of the unknown biological behavior of these tumors.

Significance of histological prostatitis in patients with urinary retention and underlying benign prostatic hyperplasia or adenocarcinoma of the prostate.

OBJECTIVE: To compare the clinical features of patients having urinary retention and benign prostatic hyperplasia (BPH) with those having adenocarcinoma of the prostate (ACP) and to evaluate the significance of histological prostatitis. PATIENTS AND METHODS: The clinical data and histopathology reports of patients with retention admitted to Tygerberg Hospital between September 1998 and June 2007 were evaluated. Statistical analysis was performed with Student's t-test, Mann-Whitney test and Fisher's exact test where appropriate and P < 0.05 was considered to indicate statistical significance. RESULTS: Prostatic histology was available in 405 patients, 204 with BPH and 201 with ACP. Comparing those with BPH and those with ACP showed statistically significant differences in mean age (69.5 vs 71.9 years), serum prostate-specific antigen (PSA) level (18.6 vs 899.5 ng/mL) and histological prostatitis (48 vs 25%) but not duration of catheterization, prostate volume or urinary tract infection (UTI). Comparing those with BPH only and those with BPH plus prostatitis showed significant differences in mean age (71.9 vs 67.1 year) and PSA level (14.6 vs 22.8 ng/mL) but not prostate volume, UTI or duration of catheterization. Comparing those with ACP only and those with ACP plus prostatitis showed significant differences in stage T4 cancer (68.1 vs 35.4%) and PSA level (1123.4 vs 232.4 ng/mL) but not age, prostate volume, UTI or duration of catheterization. CONCLUSIONS: Histological prostatitis was almost twice as common in patients with urinary retention associated with underlying BPH than in patients with ACP, but there was no significant difference in the duration of catheterization, prostatic volume or presence of UTI, suggesting that histological prostatitis more often contributes to the development of retention in patients with underlying BPH than in those with ACP. In patients with BPH, histological prostatitis was associated with urinary retention at a significantly younger age and with higher serum PSA levels. In patients with ACP, histological prostatitis was associated with urinary retention at an earlier stage of cancer.

Prospective comparison of a new visual prostate symptom score versus the international prostate symptom score in men with lower urinary tract symptoms.

OBJECTIVE: To evaluate the correlation between the International Prostate Symptom Score (IPSS) and a new Visual Prostate Symptom Score (VPSS) using pictures rather than words to assess lower urinary tract symptoms (LUTS). METHODS: Four IPSS questions related to frequency, nocturia, weak stream, and quality of life (QoL) were represented by pictograms in the VPSS. Men with LUTS were given the IPSS and VPSS to complete. Peak (Qmax.) and average (Qave.) urinary flow rates were measured. Statistical analysis was performed using Student's t, Fisher's exact, and Spearman's correlation tests. RESULTS: The educational level of the 96 men (mean age 64, range 33-85 years) evaluated August 2009 to August 2010 was school grade 8-12 (62%), grade 1-7 (28%), university education (6%), and no schooling (4%). The IPSS was completed without assistance by 51 of 96 men (53%) and the VPSS by 79 of 96 men (82%) (P<.001). Comparing education grade<7 vs grade>10 groups, the IPSS required assistance in 27 of 31 men (87%) vs 9 of 38 men (24%) (P<.001), and the VPSS required assistance in 10 of 31 men (32%) vs 3 of 38 men (8%) (P=.014). There were statistically significant correlations between total VPSS, Qmax. and Qave., total VPSS and IPSS, and individual VPSS parameters (frequency, nocturia, weak stream and QoL) vs their IPSS counterparts. CONCLUSIONS: The VPSS correlates significantly with the IPSS, Qmax. and Qave., and can be completed without assistance by a greater proportion of men with limited education, indicating that it may be more useful than the IPSS in patients who are illiterate or have limited education.

A prospective, randomized trial comparing the Vienna nomogram to an eight-core prostate biopsy protocol.

OBJECTIVE: • To compare prostate cancer detection rates using the Vienna nomogram versus an 8-core prostate biopsy protocol. To compare the complication rates of transrectal prostate biopsy in the two groups. PATIENTS AND METHODS: • In a prospective randomized trial, men with a serum PSA ≥ 2.5 ng/ml were stratified according to serum PSA (I = PSA 2.5-10; II = PSA 10.1-30; III = PSA 30.1-50 ng/mL) and were then randomized to group A (number of cores determined according to the Vienna nomogram) or group B (8-core prostate biopsy). • Statistical analysis was performed using Student's t-test for parametric data, Mann-Whitney test for nonparametric data and Fisher's exact test for contingency tables. A two-tailed p-value <0.05 was accepted as statistically significant. RESULTS: • In the period July 2006 to July 2009, 303 patients were randomized to group A (n = 152) or group B (n = 151). There were no significant differences in serum PSA, prostate volume, PSA density or post-biopsy complications between the groups. • The cancer detection rate was lower in group A than in group B for the whole study cohort (35.5% vs 38.4%), for those with PSA < 10 ng/ml (28.1% vs 33%) and for those with prostate volume >50 ml (22% vs 25.8%). These differences were not statistically significant (NSS). CONCLUSION: • These findings suggest that there is no significant advantage in using the Vienna nomogram to determine the number of prostate biopsy cores to be taken, compared to an 8-core biopsy protocol.

Diagnosis and staging of penile cancer.

A comprehensive literature study was conducted to evaluate the levels of evidence (LEs) in publications on the diagnosis and staging of penile cancer. Recommendations from the available evidence were formulated and discussed by the full panel of the International Consultation on Penile Cancer in November 2008. The final grades of recommendation (GRs) were assigned according to the LEs of the relevant publications. The following consensus recommendations were accepted: physical examination of the primary penile lesion is mandatory, evaluating the morphologic and physical characteristics of the lesion (GR A). Evaluation of the primary lesion with ultrasonography is of limited value for local tumor staging (GR C); however, evaluation of the primary tumor with magnetic resonance (MRI) imaging during artificial erection induced by intracavernosal injection of prostaglandin might be more useful (GR B). Histologic or cytologic diagnosis of the primary lesion is mandatory (GR A). For accurate histologic grading and staging, a resected specimen is preferable to a biopsy specimen alone (GR B). Penile cancer should be staged according to the TNM system; however, the 1987/2002 TNM staging system requires revision using data from larger patient cohorts to validate the recently proposed modifications (GR B). The histopathology report should provide information on all prognostic parameters, including the tumor size, histologic type, grade, growth pattern, depth of invasion, tumor thickness, resection margins, and lymphovascular and perineural invasion (GR B). Physical examination of the inguinal and pelvic areas to assess the lymph nodes is mandatory (GR B). Ultrasound-guided fine needle aspiration cytology is indicated for both palpable and nonpalpable inguinal nodes. If the findings confirm lymph node metastasis (LNM), complete inguinal lymph node dissection is indicated (GR B). In patients with nonpalpable inguinal nodes, if the ultrasound-guided fine needle aspiration cytology findings are negative for tumor, dynamic sentinel node biopsy can be performed if the equipment and technical expertise are available (GR C). In patients at high risk of inguinal LNM according to the available guidelines and nomograms, surgical staging can be performed by complete, bilateral inguinal lymph node dissection, which might also be curative (GR B). In patients at intermediate risk of LNM, sentinel node biopsy or modified (limited) inguinal lymph node dissection might be performed (GR B). In patients with nonpalpable inguinal nodes, imaging with computed tomography (CT) or MRI is not indicated, because they are not useful in detecting small-volume LNM. Also, it is very unlikely that large-volume LNM (detectable by CT/MRI) would be present in the pelvic nodes (GR B). In patients with confirmed inguinal LNM, CT of the pelvis is indicated to detect iliac LNMs (GR B). Abdominal CT and chest radiography are advisable if the pelvic CT findings are positive (GR B).

Management of the lymph nodes in penile cancer.

A comprehensive literature study was conducted to evaluate the levels of evidence (LEs) in publications on the diagnosis and staging of penile cancer. Recommendations from the available evidence were formulated and discussed by the full panel of the International Consultation on Penile Cancer in November 2008. The final grades of recommendation (GRs) were assigned according to the LE of the relevant publications. The following consensus recommendations were accepted. Fine needle aspiration cytology should be performed in all patients (with ultrasound guidance in those with nonpalpable nodes). If the findings are positive, therapeutic, rather than diagnostic, inguinal lymph node dissection (ILND) can be performed (GR B). Antibiotic treatment for 3-6 weeks before ILND in patients with palpable inguinal nodes is not recommended (GR B). Abdominopelvic computed tomography (CT) and magnetic resonance imaging (MRI) are not useful in patients with nonpalpable nodes. However, they can be used in those with large, palpable inguinal nodes (GR B). The statistical probability of inguinal micrometastases can be estimated using risk group stratification or a risk calculation nomogram (GR B). Surveillance is recommended if the nomogram probability of positive nodes is <0.1 (10%). Surveillance is also recommended if the primary lesion is grade 1, pTis, pTa (verrucous carcinoma), or pT1, with no lymphovascular invasion, and clinically nonpalpable inguinal nodes, but only provided the patient is willing to comply with regular follow-up (GR B). In the presence of factors that impede reliable surveillance (obesity, previous inguinal surgery, or radiotherapy) prophylactic ILND might be a preferable option (GR C). In the intermediate-risk group (nomogram probability .1-.5 [10%-50%] or primary tumor grade 1-2, T1-T2, cN0, no lymphovascular invasion), surveillance is acceptable, provided the patient is informed of the risks and is willing and able to comply. If not, sentinel node biopsy (SNB) or limited (modified) ILND should be performed (GR B). In the high-risk group (nomogram probability >.5 [50%] or primary tumor grade 2-3 or T2-T4 or cN1-N2, or with lymphovascular invasion), bilateral ILND should be performed (GR B). ILND can be performed at the same time as penectomy, instead of 2-6 weeks later (GR C). SNB based on the anatomic position can be performed, provided the patient is willing to accept the potential false-negative rate of /=2 nodes on one side, contralateral limited ILND with frozen section analysis can be performed, with complete ILND if the frozen section analysis findings are positive (GR B). If clinically suspicious inguinal metastases develop during surveillance, complete ILND should be performed on that side only (GR B), and SNB or limited ILND with frozen section analysis on the contralateral side can be considered (GR C). Endoscopic ILND requires additional study to determine the complication and long-term survival rates (GR C). Pelvic lymph node dissection is recommended if >/=2 proven inguinal metastases, grade 3 tumor in the lymph nodes, extranodal extension (ENE), or large (2-4 cm) inguinal nodes are present, or if the femoral (Cloquet's) node is involved (GR C). Performing ILND before pelvic lymph node dissection is preferable, because pelvic lymph node dissection can be avoided in patients with minimal inguinal metastases, thus avoiding the greater risk of chronic lymphedema (GR B). In patients with numerous or large inguinal metastases, CT or MRI should be performed. If grossly enlarged iliac nodes are present, neoadjuvant chemotherapy should be given and the response assessed before proceeding with pelvic lymph node dissection (GR C). Antibiotic treatment should be started before surgery to minimize the risk of wound infection (GR C). Perioperative low-dose heparin to prevent thromboembolic complications can be used, although it might increase lymph leakage (GR C). The skin incision for ILND should be parallel to the inguinal ligament, and sufficient subcutaneous tissue should be preserved to minimize the risk of skin flap necrosis (GR B). Sartorius muscle transposition to cover the femoral vessels can be used in radical ILND (GR C). Closed suction drainage can be used after ILND to prevent fluid accumulation and wound breakdown (GR B). Early mobilization after ILND is recommended, unless a myocutaneous flap has been used (GR B). Elastic stockings or sequential compression devices are advisable to minimize the risk of lymphedema and thromboembolism (GR C). Radiotherapy to the inguinal areas is not recommended in patients without cytologically or histologically proven metastases nor in those with micrometastases, but it can be considered for bulky metastases as neoadjuvant therapy to surgery (GR B). Adjuvant radiotherapy after complete ILND can be considered in patients with multiple or large inguinal metastases or ENE (GR C). Adjuvant chemotherapy after complete ILND can be used instead of radiotherapy in patients with >/=2 inguinal metastases, large nodes, ENE, or pelvic metastases (GR C). Follow-up should be individualized according to the histopathologic features and the management chosen for the primary tumor and inguinal nodes (GR B).

Management of radiation cystitis.

Acute radiation cystitis occurs during or soon after radiation treatment. It is usually self-limiting, and is generally managed conservatively. Late radiation cystitis, on the other hand, can develop from 6 months to 20 years after radiation therapy. The main presenting symptom is hematuria, which may vary from mild to severe, life-threatening hemorrhage. Initial management includes intravenous fluid replacement, blood transfusion if indicated and transurethral catheterization with bladder washout and irrigation. Oral or parenteral agents that can be used to control hematuria include conjugated estrogens, pentosan polysulfate or WF10. Cystoscopy with laser fulguration or electrocoagulation of bleeding points is sometimes effective. Injection of botulinum toxin A in the bladder wall may relieve irritative bladder symptoms. Intravesical instillation of aluminum, placental extract, prostaglandins or formalin can also be effective. More-aggressive treatment options include selective embolization or ligation of the internal iliac arteries. Surgical options include urinary diversion by percutaneous nephrostomy or intestinal conduit, with or without cystectomy. Hyperbaric oxygen therapy (HBOT) involves the administration of 100% oxygen at higher than atmospheric pressure. The reported success rate of HBOT for radiation cystitis varies from 60% to 92%. An important multicenter, double-blind, randomized, sham-controlled trial to evaluate the effectiveness of HBOT for refractory radiation cystitis is currently being conducted.

Evaluation of a hemostatic sponge (TachoSil) for sealing of the renal collecting system in a porcine laparoscopic partial nephrectomy survival model.

OBJECTIVE: The objective of this study was to evaluate the efficacy of TachoSil (Nycomed UK, Oxford, Buckinghamshire, UK), a hemostatic sponge, to seal major collecting system injuries (in addition to providing an adjunct to hemostasis) after partial nephrectomy in a porcine chronic survival model. MATERIALS AND METHODS: Laparoscopic upper-pole partial nephrectomies were performed in 10 farm pigs (>40 kg). After hilar clamping, an energyless incision was made at a point halfway between the hilum and the upper pole of the kidney and the collecting system was opened widely. TachoSil was applied to cover the defect; 15 to 20 minutes after the application of TachoSil, the hilar clamp was removed, hemostasis confirmed, and the pig survived. Assessment was made for hematoma and urinoma. Four weeks postoperatively, the pigs were euthanized. Ex-vivo retrograde studies were performed to assess collecting system leak. Weight, blood pressure, estimated blood loss, the weight of the partial and completion nephrectomy specimen, presence/absence of urinary leak on retrograde study, histopathologic findings, and complications were recorded. RESULTS: All pigs survived. Mean warm ischemia time was 18 minutes, mean blood loss was 90 mL, and mean resected weight was 13.7 g. There was no evidence of leak on retrograde study. Histologically, nonspecific changes were noted in all specimens, which included dystrophic calcification, scarring, and areas of fibrosis at the partial nephrectomy surgical margin. CONCLUSION: TachoSil seals the collecting system after partial nephrectomy on a porcine chronic survival model, in addition to providing an adjunct to hemostasis. More studies, including human trials, are warranted to evaluate this observation further.

Triptorelin 6-month formulation in the management of patients with locally advanced and metastatic prostate cancer: an open-label, non-comparative, multicentre, phase III study.

BACKGROUND AND OBJECTIVES: Triptorelin 6-month formulation was developed to offer greater convenience to both patients and physicians by reducing the injection frequency. The efficacy, pharmacokinetics and safety of a new 6-month formulation of triptorelin were investigated over 12 months (48 weeks). The primary objective was to evaluate the formulation in achieving castrate serum testosterone levels (< or = 1.735 nmol/L or < or = 50 ng/dL) on day 29 and in maintaining castration at months 2-12. Absence of luteinizing hormone (LH) stimulation and change in prostate-specific antigen (PSA) level were also assessed. METHODS: An open-label, non-comparative, phase III study in 120 patients with advanced prostate cancer was conducted from July 2006 to August 2007 in private and public institutions in South Africa. Each patient received two consecutive intramuscular injections of triptorelin embonate (pamoate) 22.5 mg at an interval of 24 weeks. In all patients, testosterone (primary outcome measurement) was measured at baseline and then every 4 weeks; LH was measured before and 2 hours after the two injections. PSA was measured on day 1 and at weeks 12, 24, 36 and 48. Adverse events were recorded at each visit. RESULTS: In the intent-to-treat population, 97.5% (95% CI 92.9, 99.5) of patients achieved castrate serum testosterone levels by day 29, and 93.0% (95% CI 86.8, 97.0) maintained castration at months 2-12. After the second injection, 98.3% of patients showed absence of LH stimulation. The most frequent drug-related adverse events were hot flushes (71.7% of patients). No patient withdrew from the study as a result of an adverse event. CONCLUSIONS: The triptorelin 6-month formulation was well tolerated and was able to achieve and maintain castration for the treatment of locally advanced and metastatic prostate cancer. By reducing the frequency of required injections, this new formulation offers a more convenient treatment regimen. (Clinical Trial Registration,NCT00751790 at www.clinicaltrials.gov).