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Purpose: Renal cell carcinoma develops in renal transplant recipients 30 or more times more commonly than in the general population. We assessed the prevalence, histology and outcome of renal cell carcinoma in a large, single center recipient population., Materials and Methods: We examined outcomes in patients who underwent renal transplantation at our center to determine the prevalence, histology and outcome of those in whom renal cell carcinoma developed., Results: A total of 3,568 patients received a renal allograft at our institution between 1966 and 2009. A total of 45 renal cell carcinomas were diagnosed in the native kidney of 39 patients (1.1%) and in 8 (0.2%) renal cell carcinoma developed in the allograft kidney. Mean age at diagnosis was 51.6 and 48.2 years in patients with native kidney and allograft tumors, respectively. The mean interval between transplantation and the native or allograft renal cell carcinoma diagnosis was 10.6 and 12.1 years, respectively. Clear cell renal cell carcinoma was the most common tumor histology in native kidneys, diagnosed in 21 cases, while papillary renal cell carcinoma was diagnosed in 20. Five allograft tumors were papillary renal cell carcinoma and 3 were clear cell renal cell carcinoma. Native kidney tumors were managed by radical nephrectomy in 44 or by observation after biopsy. Allograft tumors were managed by transplant nephrectomy in 3 cases, radio frequency ablation in 3 and partial nephrectomy in 2. At a mean 6.6-year followup 32 patients with native kidney renal cell carcinoma were alive while 7 with allograft tumors were alive at a mean 3.6-year followup., Conclusions: Renal cell carcinoma is more prevalent in patients with renal transplantation than the general population, although the subtype distribution differs. Excellent survival is seen at more than 6 years after treatment., (Copyright © 2011 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Purpose: Positive surgical margins have a negative impact on disease outcomes after radical prostatectomy, yet their prognostic value may vary depending on specific pathological characteristics. We examined the relationship of positive surgical margins to biochemical progression according to several clinicopathological features., Materials and Methods: We analyzed data from 1,268 patients who underwent radical prostatectomy for clinically localized prostate cancer at our center between 1992 and 2008, and did not receive any neoadjuvant or adjuvant treatment. We examined the relation of age, pretreatment prostate specific antigen, pathological T stage, radical prostatectomy Gleason score, disease risk group and surgical margin status to biochemical progression-free survival., Results: The overall positive surgical margin rate was 20.8% and median followup was 79 months. The impact of positive surgical margins was dependent on risk group. Biochemical progression-free survival was 99.6% for the negative surgical margin group vs 94.9% for the positive surgical margin group in low risk disease (log rank p = 0.53), 93.5% for the negative surgical margin group vs 83% for the positive surgical margin group in intermediate risk disease (log rank p <0.001) and 78.5% for the negative surgical margin group vs 57.1% for the positive surgical margin group in high risk disease (log rank p = 0.003). These differences remained significant in a multivariate Cox regression model adjusting for other clinicopathological features., Conclusions: Positive surgical margins are an independent predictor of biochemical progression in patients with intermediate and high risk prostate cancer. Patients with low risk disease have a favorable long-term outcome regardless of margin status and may be candidates for expectant management even with positive surgical margins, sparing them the side effects and costs of treatment.

Purpose: Laparoscopic or robot assisted laparoscopic radical prostatectomy is often performed via a transperitoneal approach for prostate cancer, in contrast to open retropubic radical prostatectomy. Theoretically transgressing the peritoneum may introduce small bowel loops into the pelvis, increasing the risk of small bowel injury with adjuvant radiotherapy. We compared the incidence of small bowel within the planning target volume for radiotherapy to the prostate bed in patients who underwent open retropubic and laparoscopic radical prostatectomy., Materials and Methods: A total of 25 patients recently treated with laparoscopic radical prostatectomy prospectively provided consent to undergo radiotherapy planning computerized tomography simulation to assess the incidence of small bowel within the prostate bed planning target volume. These studies were compared to radiotherapy planning computerized tomography in 50 patients who underwent open retropubic radical prostatectomy and received adjuvant or salvage radiotherapy for prostate cancer. For all computerized tomography images 1 blinded observer delineated the distal small bowel loops and 1 blinded radiation oncologist delineated the superior extent of clinical and planning target volumes., Results: The overlap rate between small bowel and planning target volume was 16% in the laparoscopic and open radical prostatectomy groups (p = 0.579)., Conclusions: There is no difference between transperitoneal laparoscopic and open retropubic radical prostatectomy in the incidence of small bowel within the planning target volume for radiotherapy to the prostate bed. Thus, patients who undergo transperitoneal laparoscopic radical prostatectomy do not face a higher risk of toxicity or compromise due to adjuvant or salvage radiotherapy should they require it.

Purpose: Differentiation between Gleason score 6 and 7 in prostate biopsy is important for treatment decision making. Nevertheless, under grading errors compared with the actual pathological grade at radical prostatectomy are common. We compared the characteristics and outcomes of tumors that were scored 6 on prostate biopsy but were 7 on subsequent radical prostatectomy pathological evaluation to those in tumors with a consistent rating of Gleason score 6 or 7 at biopsy and surgery., Materials and Methods: We performed a retrospective database analysis from our referral center (1989 to 2004). We compared pre-prostatectomy characteristics, radical prostatectomy pathological features and the post-radical prostatectomy prostate specific antigen failure rate, defined as any 2 consecutive detectable prostate specific antigen measurements, in 3 subgroups of patients, including 156 with matched Gleason score 6 in the prostate biopsy and radical prostatectomy, 205 with upgraded Gleason score 6/7, that is prostate biopsy Gleason score 6 and radical prostatectomy Gleason score 7, and 412 with matched Gleason score 7 in the prostate biopsy and radical prostatectomy., Results: Radical prostatectomy Gleason score matched the prostate biopsy score in 38.2% of biopsy Gleason score 6 and 81.4% of biopsy Gleason score 7 cases. Higher prostate specific antigen was associated and an increased percent of cancer in the prostate biopsy was predictive of discordance between the prostate biopsy and radical prostatectomy Gleason scores (p <0.001). Margin (p = 0.0075) or seminal vesicle involvement (p = 0.0002), cancer volume (p <0.001) and the prostate specific antigen failures rate (p = 0.014) were significantly higher in under graded Gleason score 7 cancer compared to those in matched Gleason score 6 cases. However, they were comparable to those with a matched Gleason score 7 tumor grade (p = 0.66)., Conclusions: Almost half of tumors graded Gleason score 6 at biopsy are Gleason score 7 at surgery. Upgraded Gleason score 6 to 7 tumors have outcomes similar to those of genuine Gleason score 7 cancer. For prostate biopsy Gleason score 6 tumors clinicians should consider the overall likelihood of tumor upgrading as well as specific patient characteristics, such as prostate specific antigen and the percent of tumor in the prostate biopsy, when contemplating treatments that are optimized for low grade tumors, including watchful waiting or brachytherapy.

Purpose: Urachal carcinoma accounts for less than 1% of all bladder cancers. Limited data exist on disease related outcomes originating from case reports and select referral centers. We describe a population based outcomes analysis with long-term followup in patients in the province of Ontario., Materials and Methods: We reviewed the data source of the Ontario Cancer Registry for patients diagnosed with urachal cancer during 1976 to 2001. A cohort of 40 patients with urachal adenocarcinoma was found. Primary outcome measures were overall and disease specific survival. The effect of patient age, sex, grade, stage and university vs nonacademic treating hospital as predictors of outcome was determined., Results: Median patient age was 52 years. Median followup was 72.7 months. Mean overall survival +/- SD was 121.6 +/- 21 months. Mean disease specific survival in patients treated operatively was 165 +/- 27 months with 5 and 10-year disease specific survival of 61.3% and 49.2%, respectively. Disease specific mortality was not evident after 7 years from diagnosis. Well differentiated tumors in a third of the patients were associated with a 90% cure rate when treated operatively. Well differentiated tumors, and noninvolvement of adjacent organs and the peritoneum correlated with better prognosis (p = 0.004, p = 0.03 and 0.045, respectively)., Conclusions: Urachal adenocarcinoma occurs in all age groups. Long-term disease specific survival can be achieved with partial cystectomy. Covariates associated with better disease specific survival are well differentiated tumor grade and the absence of adjacent organ or peritoneal involvement. No relapses were observed after 7 years.

Purpose: In 1992 we initiated a national randomized prospective trial of 3 months of cyproterone acetate before radical prostatectomy compared to prostatectomy alone. Initial results indicated a 50% decrease in the rate of positive surgical margins. This decrease did not translate into a difference in prostate specific antigen (PSA) progression at 3 years. This report is on the long-term outcome (median followup 6 years) of this cohort., Materials and Methods: This prospective, randomized, open label trial compared 100 mg cyproterone acetate 3 times daily for 3 months before surgery to surgery alone. Randomization occurred between January 1993 and April 1994. Patients were stratified according to clinical stage, baseline serum PSA and Gleason sum. A total of 213 patients were accrued. Biochemical progression was defined as 2 consecutive detectable PSAs (greater than 0.2 ng/ml) at least 4 weeks apart, re-treatment or death from prostate cancer., Results: A total of 34 (33.6%) patients undergoing surgery only and 42 (37.5%) patients given neoadjuvant hormone therapy (NHT) had biochemical recurrence during the median followup of 6 years. Despite the significant pathological down staging in this study, there was no significant difference in number of patients with no evidence of biochemical disease (bNED) survival (p = 0.732). A bNED survival benefit favoring NHT was seen in men with a baseline PSA greater than 20 (p = 0.015)., Conclusions: After 6 years of followup there was no overall benefit with 3 months of NHT. Improved bNED survival was seen in the highest risk PSA group (PSA greater than 20). The possibility that high risk patients may benefit from NHT warrants further investigation.

Purpose: A prospective phase 3 trial was initiated to determine whether 8 compared with 3-month neoadjuvant hormonal therapy reduces prostate specific antigen (PSA) recurrence rates after radical prostatectomy. Our interim analysis includes secondary end points of differences in biochemistry, pathology and adverse events between the 2 groups., Materials and Methods: Men with clinically confined prostate cancer were randomized to receive 7.5 mg. leuprolide intramuscularly monthly and 250 mg. flutamide orally 3 times daily for 3 or 8 months before radical prostatectomy. Our study was powered to detect a 35% decrease in PSA recurrence, assuming a 30% recurrence rate in the 3-month arm after 3 years., Results: A total of 547 men were randomized between August 1995 and April 1998. Men in the 8 and 3-month groups were equally stratified for T stage (29% T1c, 70% T2), Gleason grade (68% less than 4, 32% 4 or greater) and pretreatment PSA (63% less than 10, 27% 10 to 20 and 10% greater than 20 microg./l.). Mean pretreatment PSA was slightly higher in the 8-month compared with the 3-month group (11.64 versus 9.95 microg./l., respectively, p = 0.0539). A total of 44 men withdrew from study before surgery and, therefore, were nonevaluable. Preoperative PSA nadir was less than 0.1 microg./l. in 43.3% versus 75.1% (p <0.0001), and 0.3 microg./l. or greater in 21% versus 9.2% after 3 versus 8 months, respectively (p <0.0006). Mean serum PSA decreased 98% to 0.12 microg./l. after 3 months, with a further 57% to 0.052 microg./l. from 3 to 8 months. Transrectal ultrasound determined that prostatic volume decreased 37% from a mean of 40.6 to 25.4 cc after 3-month neoadjuvant hormonal therapy (p = 0.0001) and a further 13% to 22.2 cc after 8 months (p = 0.03). Mean hemoglobin decreased 15% (148.2 to 125.4 gm./dl.) after 3-month neoadjuvant hormonal therapy but stabilized thereafter. Radical prostatectomy was completed in 500 men, while surgery was aborted intraoperatively in 3. Positive margin rates were significantly lower in the 8 than 3-month group (12% versus 23%, respectively, p = 0.0106). There were no fatal adverse events and no differences between the 2 groups in the severity or causality (p = 0.287, 0.0564) of adverse events, or incidence of increased liver enzymes or diarrhea (p = 0.691, 0.288, respectively). However, men in the 8-month group noticed a higher number of newly reported adverse events (4.5 versus 2.9, p <0.0001) and higher incidence of hot flushes than the 3-month group (87% versus 72%, respectively, p <0.0001)., Conclusions: Ongoing biochemical and pathological regression of prostate tumors occurs between 3 and 8 months of neoadjuvant hormonal therapy, suggesting that the optimal duration of neoadjuvant hormonal therapy is longer than 3 months. Longer followup is needed to determine whether longer therapy alters PSA recurrence rates.

Purpose: Incidentally detected small renal tumors appear to grow slowly and be localized to the kidney. Minimally invasive therapies are being investigated as alternatives to standard surgical techniques. Radiofrequency ablation has been reported for the treatment of small renal cell carcinomas. We developed a radiofrequency technique and established its efficacy and safety in a large animal model., Methods and Methods: A total of 22 lesions were created in normal kidneys of 7 pigs. Radiofrequency energy was administered during open exposure of the kidneys or percutaneously under ultrasound guidance. Lesion development was monitored with gray-scale and power Doppler ultrasound. To avoid heating surrounding tissues new hydro-dissection and gas-dissection techniques were developed. Lesion sizes and characteristics were assessed by ultrasound and pathological examination., Results: No complications were observed due to probe insertion and removal. Perirenal structures were thermally damaged before the development and application of the dissection techniques. Lesion size was accurately predicted by gray-scale ultrasound on day 7. Loss of perfusion in the ablated volume was confirmed by power Doppler ultrasound. Lesions were wedge-shaped, presumably due to the effects of heating on segmental blood flow distribution. Pathological examination revealed changes consistent with thermal injury and ischemic type infarction., Conclusions: Radiofrequency thermal therapy is an effective and efficient method for ablating normal renal tissue in the pig. It may be applied percutaneously under ultrasound guidance with minimal complications provided that vital adjacent structures are protected from thermal damage. Further studies are required in humans before adopting this technique as definitive treatment for small renal cell carcinoma.

Purpose: We correlated serum and urinary biochemical parameters with radiological evidence of stone growth after shock wave lithotripsy., Materials and Methods: Biochemical parameters in serum and 24-hour urine collections of 359 patients were correlated with stone growth for 2 years after shock wave lithotripsy. Each patient underwent a minimum of 2 radiological studies at 3 and 12 months and plain abdominal x-ray at 24 months. The presence and size of stones were documented by a radiologist in blinded fashion. Stone growth was defined as measurable growth of a preexisting stone or new stone formation., Results: A total of 209 patients remained stone-free or had no existing stone growth, while stone size decreased in 30. Of the remaining 120 patients with stone growth 72 had new growth and 48 had growth of preexisting stones. Urinary excretion of potassium was significantly higher in those without than with stone growth (mean 24-hour urine collection plus or minus standard deviation 62 +/- 27 versus 54 +/- 23 mmol., p = 0.009). The only parameter significantly associated with stone growth was urinary potassium. Linear regression revealed that for each 10 unit increase in urinary potassium there was a corresponding 2 mm. decrease in stone growth (p = 0.013)., Conclusions: Our results indicate that increased urinary potassium excretion correlates with a decreased risk of stone growth up to 2 years after shock wave lithotripsy, implying that a high potassium diet may be beneficial for preventing stone growth. The effect of potassium supplementation on stone formation and growth must be investigated further.

Purpose: We determine if mapping of the cavernous nerve during radical prostatectomy using intraoperative cavernous nerve stimulation with tumescence monitoring results in improved erectile potency compared to conventional nerve sparing., Materials and Methods: A prospective, randomized, single blinded study was performed on 61 patients at 6 centers. Patients had elected to undergo nerve sparing prostatectomy and had normal preoperative erectile function documented by the Sexual Function Inventory Questionnaire (SFIQ) and RigiScan parallel testing. Patients were randomized between conventional nerve sparing and nerve sparing assisted by the CaverMap Surgical Aid. paragraph sign In all patients neural continuity was assessed immediately after prostate removal by proximal cavernous nerve stimulation. All patients were blinded according to their allocation cohort., Results: At 1 year there was substantial improvement in erectile function in the CaverMap group as measured by RigiScan. This group had a mean of 15. 9 minutes of greater than 60% nocturnal tumescence compared to 2.1 minutes in the conventional nerve sparing group (p <0.024). By SFIQ there was a nonsignificant trend to improved potency in the CaverMap group (71% versus 62%, p = 0.17). Of patients who had bilateral, unilateral and no response to stimulation after resection erectile function assessed by SFIQ recovered in 68%, 27% and 0%, respectively (p = 0.016)., Conclusions: CaverMap assisted prostatectomy led to improved erectile function as assessed by RigiScan testing with no associated adverse events. A response to stimulation immediately after removal of the prostate accurately predicted return of erectile function.

Purpose: Ultrasound, computerized tomography and magnetic resonance imaging are widely available. Incidentally discovered small renal masses are reported more frequently. Most of these masses are low stage renal cell carcinomas. To understand better the natural history of these lesions and offer appropriate management, we followed prospectively a series of patients with this type of lesion., Materials and Methods: A total of 13 patients with radiologically detected solitary small renal masses who were unfit for or refused surgery were followed with abdominal imaging for a median of 42 months. Median patient age was 69 years and mean lesion volume at diagnosis was 13.6 cm.3 or 2.95 cm. in diameter. Growth rate was calculated based on tumor volume rather than bi-dimensional diameter. Individual slopes of tumor size in time were calculated., Results: Of the 13 patients 5 underwent surgery following a period of surveillance because of apparent tumor enlargement or new onset of symptoms. Pathological evaluation revealed renal cell carcinoma in all 5. No patient had metastases. Only 2 tumors were fast growing and these were the only 2 cases in which symptoms developed. When these patients were excluded from analysis, average growth rate was 1.32 cm.3 per year (p = 0.5, 95% confidence interval -3.00 to 5.76 cm.3 per year), which was not statistically significantly different from 0 slope or no growth., Conclusions: These results demonstrate that the growth rate of small renal tumors is variable, tumors that are destined to grow and possibly metastasize do so early and most small tumors grow at a low rate or not at all.

Purpose: The CAG repeat polymorphism of the androgen receptor gene has been associated with an increased prostate cancer risk, and the repeat length correlated with cancer stage and grade at presentation. Men with an allele length of 18 CAG repeats, controlling for grade, stage and serum PSA level at diagnosis using Cox proportional hazard modeling., Results: Overall, the CAG repeat allele was not predictive of recurrence; tumor grade, stage and PSA level at diagnosis were the only predictors of recurrence in a multivariate analysis. However, for patients at low risk for recurrence (Gleason score 2 to 6, stage pT2, and PSA 18 CAG repeats. In contrast, for patients at high risk of recurrence (Gleason score >/= 7, stage pT3/4, or PSA >10 ng./ml.), the relative risk associated with the 18 CAG repeat allele., Conclusions: The length of the CAG repeat polymorphism of the androgen receptor gene may be important for prostate cancer recurrence among patients who are otherwise at low risk for recurrence after radical prostatectomy. These findings have potential implications for patient selection for adjuvant treatment, and for the development of novel treatments.

Purpose: We measure and compare operator specific success rates of extracorporeal shock wave lithotripsy (ESWL) performed by 12 urologists in 1 unit to determine interoperator variation., Materials and Methods: From January 1, 1994 to September 1, 1997 a total of 5,769 renal and ureteral stones received 9,607 ESWL treatments by 15 urologists with a Dornier MFL 5000 lithotriptor. The 3-month followup data are available for 4,409 stones. Outcome measures consisted of patient demographics, stone characteristics, technical details of lithotripsy, and stone-free and success rates by treating urologists., Results: Treatment results were analyzed for 12 urologists (surgeons A to L) who treated more than 100 stones each, totaling 4,244 with followup information available. Mean stone-free and success rates were 50.6% and 72.3%, respectively. Surgeon A had significantly higher stone-free and success rates of 56.2% and 76.7%, respectively (p<0.05), with treatment results from 877 stones, which was a significantly higher number than others (p<0.05). Significant differences existed in mean number of shocks delivered among urologists (p = 0.0001), with surgeons A and J delivering the highest mean numbers (2,317 and 2,801, respectively). There was no difference in treatment duration (p = 0.75) but variation existed among urologists in terms of mean maximum treatment voltage (p = 0.0001). Mean fluoroscopy time at 4.1 minutes was higher for surgeon A than others (p<0.05). Mean complication rate following ESWL was 4.9% with no difference among urologists (p = 0.175). Re-treatment was required in 21.7% of cases and surgeon A had the lowest rate (15.9%, p<0.05)., Conclusions: We demonstrated clinically and statistically significant intra-institutional differences in success rates following ESWL. The best results were obtained by the urologist who treated the greatest number of patients, used a high number of shocks and had the longest fluoroscopy time. Accurate targeting is crucial when using a lithotriptor, such as the Dornier MFL 5000, with a narrow focal zone of 6.5 mm. in diameter. Other centers should be encouraged to develop similar programs of outcome analysis in an attempt to improve performance.

Purpose: Patients with superficial bladder cancer require long-term surveillance for recurrence. We compared the cost of cystoscopy and cytology (standard care) to that of urinary markers (modified care) for patients with a history of superficial bladder cancer., Materials and Methods: We constructed a decision analysis model that compared the 2 strategies for a hypothetical followup interval of 3 years. Probabilities required for the decision tree were based on a cohort of 361 patients diagnosed with superficial bladder cancer from 1987 to 1997. Sensitivity analyses were used to determine whether test sensitivity and specificity would affect cost thresholds. Costs for each strategy were then applied to actual practice patterns., Results: The cost of modified care ranged from $158 to $228 for each followup visit when using a urinary marker with a sensitivity and specificity of 95% and 77%, respectively. The cost of standard care was $240 for each followup visit. Based on sensitivity analyses the probability of disease recurrence and urinary marker accuracy were important determinants of expected costs. Mean number of followup assessments for patients followed more than 3 years was 4.3, 2.2 and 1.5 for years 1, 2 and 3, respectively. Cumulative costs of modified care were lower than those of standard care., Conclusions: Urinary marker testing for followup of patients with superficial bladder cancer is less expensive than the standard method of cystoscopy and urinary cytology based on our model. Future studies will be required to consider other factors that could affect the cost advantage of urinary markers, including indirect costs, the psychosocial impact of testing and different surveillance frequencies.

Purpose: We examine disease control and patterns of failure for patients with adult paratesticular sarcoma treated with wide repeat excision and postoperative radiation for close margins., Materials and Methods: A retrospective analysis was performed on 14 patients with paratesticular sarcomas referred to 1 institution from 1988 to 1995., Results: Median followup was 50 months (range 26 to 90). Pathology review revealed malignant fibrous histiocytoma in 5 cases and liposarcoma in 3. Tumor grade was high in 8 cases. Microscopic residual disease was identified after repeat excision in 3 of 11 completely excised cases (27%). Cause specific survival 5 years after diagnosis was 70%. Both patients with local failure after wide excision had undergone initial intralesional excision and 1 had also received postoperative irradiation. In 5 patients metastases developed in the liver, lung, nodes or multiple sites 0 to 60 months after diagnosis., Conclusions: Simple excision is inadequate treatment for paratesticular sarcoma, since wide repeat excision revealed microscopic residual disease in 27% of completely excised cases. The 2 local failures occurred in patients with a history of inadvertent intralesional surgery, which may be a risk factor for local relapse after wide repeat excision. Adjuvant radiation should be considered for these patients as well as those with narrow repeat resection margins. Systemic failure was frequent in patients with high grade tumors, who will require effective systemic adjuvant therapy.

Purpose: A multicenter study was undertaken to evaluate the safety, efficacy and cost of electromotive drug administration of intravesical lidocaine to produce bladder local anesthesia as an alternative to traditional methods of spinal or general anesthesia., Materials and Methods: A total of 94 patients were enrolled in the study who had either a history of bladder tumor that required cold cup bladder biopsy with fulguration for possible recurrence as a comparison trial, a bladder tumor treated with transurethral resection/fulguration or benign prostatic hyperplasia/carcinoma treated with transurethral resection. Pain scores using a Verbal Rating Scale were recorded for each individual biopsy, fulguration and resection event. Data for direct and indirect costs were collected using a standardized form for each patient to capture the details of the procedure, including times, drugs and disposables for each patient., Results: There was a significant reduction in pain for patients who received electromotive intravesical lidocaine compared to no anesthesia for biopsy (p<0.03). Similarly, electromotive intravesical lidocaine for bladder biopsy and transurethral bladder tumor resection/fulguration was associated with higher patient satisfaction compared to previous treatments (p<0.00002). In contrast, electromotive intravesical lidocaine was insufficient for 3 of 6 transurethral prostatic resections. The cost per patient was about $146 Cdn less with electromotive intravesical lidocaine than with conventional general/spinal anesthesia., Conclusions: Electromotive intravesical lidocaine may be a safe, effective and affordable form of anesthesia for the ambulatory care of patients requiring transurethral bladder biopsy, resection or fulguration with a potential for cost savings.

Purpose: To optimize followup in patients with stage I nonseminomatous testis cancer on surveillance we evaluated the contribution of each followup modality to the detection of progression as well as morbidity and mortality outcomes., Materials and Methods: After orchiectomy 170 patients with clinical stage I nonseminoma were prospectively placed on a surveillance protocol. History, physical examination, serum tumor markers, abdominal and pelvic computerized tomography (CT), and chest x-ray were used for followup. The number of failures, methods and timing of progression detection, treatments required, mortality rate and subsequent contralateral primary tumors were recorded., Results: The 170 surveillance patients were followed a median of 6.3 years. Within 2 years (median 6.9 months) postoperatively 48 patients (28.2%) had disease progression. History, physical examination, markers, CT and chest radiography provided the initial evidence of progression in 18 (37.5%), 34 (70.8%), 34 (70.8%), and 4 (8.3%) patients, respectively. Each modality was the only indicator of failure in 2 (4.2%), 4 (8.3%), 10 (20.8%) and 0 cases, respectively. Of the 170 patients 122 (71.8%) required no additional treatment beyond orchiectomy, 26 (15.3%) received 1 and 22 (12.9%) underwent more than 1 therapeutic modality. Only 1 patient (0.6%) died of disease. Contralateral tumors developed in 5 cases (2.9%) therapeutic a mean of 8.1 years after orchiectomy., Conclusions: In stage I nonseminoma patients, surveillance history, physical examination, tumor markers and abdominopelvic CT are necessary components of the followup protocol. Removal of routine chest x-ray from the protocol would not have changed progression detection. The initial surveillance visit must occur by 2 months postoperatively. Patients should be followed beyond 5 years and likely for life in addition to regular patient self-examination.

Purpose: To answer the question of whether extracorporeal shock wave lithotripsy (ESWL*) induces hypertension, a prospective, randomized controlled trial of normotensive patients with asymptomatic renal calculi was designed., Materials and Methods: Patients were randomized to receive immediate ESWL versus observation, reserving ESWL for the onset of symptoms. The rates of new onset hypertension were evaluated for both groups., Results: There was no observed difference in the incidence of hypertension between the treatment and observation groups., Conclusions: The risk of hypertension in patients undergoing ESWL therapy is similar to that of a control cohort of initially observed asymptomatic patients.

Purpose: We sought to identify prognostic factors predictive of disease progression in patients with clinical stage I seminoma on surveillance following orchiectomy., Materials and Methods: Between January 1981 and December 1993, 201 patients 20 to 86 years old (median age 34) with clinical stage I seminoma were placed on surveillance following orchiectomy. The potential prognostic factors studied included age, tumor size, mitotic count, S phase fraction, ploidy, presence of small vessel invasion, syncytiotrophoblasts and tumor infiltrating lymphocytes, expression of beta-human chorionic gonadotropin and low molecular weight keratin on immunohistochemistry., Results: With a median followup of 6.1 years (range 1.3 to 12.3) 31 patients had relapse for an actuarial 5-year relapse-free rate of 84.9%. The 5-year actuarial survival rate was 97.1% and the cause specific survival rate was 99.5%. On univariate analysis factors predictive of relapse were tumor size (5-year relapse-free rate 88 and 67% for tumors 6 cm. or less and greater than 6 cm., respectively, p = 0.004), age (5-year relapse-free rate 79 and 91% for age 34 years or younger versus older than 34 years, respectively, p = 0.009) and presence of small vessel invasion (5-year relapse-free rate 86 versus 69%, p = 0.01). On multivariate analysis age and tumor size were predictive of relapse, while small vessel invasion approached statistical significance. The risk of relapse in 57 patients with none of the 3 adverse prognostic factors (age greater than 34 years, tumor 6 cm. or smaller and no small vessel invasion) was 6%., Conclusions: We identified age, size of the primary tumor and small vessel invasion as important prognostic factors for relapse in patients with stage I seminoma treated with surveillance. Further followup and assessment of biological factors are needed to optimize selection of patients at a high risk for relapse who should receive immediate postoperative therapy.

Purpose: A prospective, multicenter, randomized study was done to test the hypothesis that neoadjuvant androgen withdrawal decreases the incidence of positive margins following radical prostatectomy for localized prostate cancer., Materials and Methods: Observations were made of 213 patients randomized to undergo radical prostatectomy alone (101) or to receive a 12-week course of 300 mg. cyproterone acetate daily followed by surgery (112). Groups were similar at baseline in terms of clinical stage, serum prostate specific antigen and Gleason score. Of 192 patients available for efficacy analysis 9 had stage T1b, 8 stage T1c, 63 stage T2a, 36 stage T2b and 76 stage T2c disease., Results: One or more positive surgical margins were found in 59 of 91 patients (64.8%) in the surgery only group compared to 28 of 101 (27.7%) in the cyproterone acetate group (p = 0.001). Patients who received preoperative therapy had a statistically significantly lower rate of apical margin involvement than those who did not (17.8 versus 47.8%, respectively, p < 0.0001). There was no statistically significant difference in surgical (p = 0.8645) or postoperative (p = 0.173) complications between the 2 groups., Conclusions: Neoadjuvant androgen withdrawal with a 12-week course of 300 mg. cyproterone acetate daily results in a lower rate of positive margins without adversely affecting postoperative recovery. The impact on patient survival will be determined by long-term followup.

Purpose: There is theoretical concern that stone recurrence rates may be higher following extracorporeal shock wave lithotripsy (ESWL) compared to other techniques because of residual stone debris., Materials and Methods: We documented all new stone formations in 298 consecutive patients who initially achieved a stone-free status following ESWL for renal calculi less that 2 cm in largest dimension, and compared the findings to those of 62 patients treated with percutaneous nephrolithotomy without ultrasonic fragmentation. Stone-free status was assessed by a centrally reviewed plain abdominal film and renal tomograms at 3 months. A plain abdominal film was repeated at 12 and 24 months to detect recurrence., Results: New stones formed in 22.2% of patients after ESWL and 4.2% after percutaneous nephrolithotomy at 1 year (p = 0.004), and in 34.8% versus 22.6%, respectively, at 2 years (p =0.190). Furthermore, more new stones recurred in the lower and mid calices compared to baseline location in the ESWL group (chi-square <0.0001), which was not observed in the percutaneous nephrolithotomy group., Conclusions: Our data support a trend toward higher stone recurrence rates in ESWL treated patients, which may be due to microscopic sand particles migrating to dependent calices and acting as a nidus for new stone formation.

To examine the factors and patient characteristics predisposing to formation of calcium oxalate monohydrate or calcium oxalate dihydrate kidney stones, we compared blood and 24-hour urine tests, gender distribution and patient age in 2 groups of patients with pure calcium oxalate monohydrate (422) and calcium oxalate dihydrate (68) stones treated at the lithotripsy unit of the Wellesley Hospital and University of Toronto during 4 years. The calcium oxalate monohydrate group included relatively more women (31% versus 16% in the calcium oxalate dihydrate group, chi-square 7.89, p = 0.005). Patients were older in the calcium oxalate monohydrate group (59 +/- 13 versus 51 +/- 13 years, p = 0.001). The calcium oxalate monohydrate group had lower urinary calcium (4.19 +/- 2.34 versus 7.19 +/- 3.38 mmol. per day, p < 0.0001), calcium oxalate relative saturation rate (6.9 +/- 3.9 versus 8.9 +/- 3.3, p = 0.001), brushite relative saturation rate (0.7 +/- 0.8 versus 1.2 +/- 0.9, p = 0.0001) and urinary pH (5.72 +/- 0.75 versus 5.93 +/- 0.72). When corrected for patient age and gender, the calcium oxalate dihydrate group still had higher urine calcium levels. Higher urine pH in the calcium oxalate dihydrate group was age-related. In summary, we present evidence that calcium oxalate dihydrate stones are relatively more common among younger male patients with higher urine calcium levels and higher urine pH.

We used an abdominal compression belt in 50 patients undergoing extracorporeal shock wave lithotripsy with the Siemens Lithostar lithotriptor to limit diaphragmatic excursion and, therefore, renal calculus movement. Stone movement was measured on the monitor with and without the compression belt. Abdominal compression was found to decrease the range of stone movement by an average of 32% (-4 to 63%). This technique was less effective in patients with limited chest expansion. Abdominal compression was also found to be useful during treatment of renal and upper ureteral stones in reducing overall patient movement. The decreased stone movement during extracorporeal shock wave lithotripsy with abdominal compression may increase stone fragmentation and may decrease the number of shocks per treatment.

To our knowledge this study of our first consecutive 1,000 patients treated with the Siemens Lithostar device is the largest prospective series reported to date. Treatment results were determined at 3, 12 and 24 months after completion of therapy. The results at 3 months are presented. Complete followup data were available on 801 patients: 674 with renal and 127 with ureteral calculi. Results were analyzed according to stone size, location and number. The average number of shocks per treatment was 3,804 and the retreatment rate was 18.6%. At 3 months the stone-free rate was determined by a plain film of the kidneys, ureters and bladder and plain tomograms for renal calculi, and by an excretory urogram for ureteral calculi. The stone-free rate was 52% for renal and 76% for ureteral calculi. The overall stone-free rate for all calculi was 55.7%. Success rate, defined as stone-free or asymptomatic residual fragments measuring 4 mm. or less, was 72% for renal and 83% for ureteral calculi. The overall success rate for all calculi was 73.9%.

The potential for variability among observers interpreting diagnostic tests is well known but has not been well established for radiological imaging of urolithiasis. We measured the inter-observer and intra-observer variability in the reporting of plain abdominal films and tomograms from patients who had undergone extracorporeal shock wave lithotripsy (ESWL). Unlabeled copies of the plain abdominal films and tomograms for 58 patients were individually submitted to 3 different radiologists. Selected films from 25 patients were resubmitted to the same radiologists. We found differences among radiologists reporting plain abdominal films alone 52% of the time and even by the same radiologist rereading the films 24% of the time. Tomograms alone decreased the uncertainty but differences still occurred among radiologists 24% of the time and with themselves 16% of the time. When plain abdominal films and tomograms were read together there were differences among radiologists 28% of the time and with themselves 7% of the time but these were usually minor. We concluded from this study that the plain abdominal film alone was frequently difficult to interpret, resulting in uncertainty about the presence or absence of residual stone fragments. Tomograms alone or a plain abdominal film plus tomograms is superior to a plain abdominal film alone. Finally, radiological assessment with all modalities probably overestimates stone-free rates after ESWL even without consideration of the potential for reporting variability among observers.

The Siemens Lithostar lithotriptor was used to treat 20 children (4 to 17 years old) with renal or ureteral calculi. Two patients had bilateral renal and 2 had ureteral calculi. Of 34 calculi treated 47% were in the renal pelvis, 29% in the lower calix, 12% in the upper calix, 3% in the middle calix and 9% in the upper ureter. Stone size ranged from 2 X 2 to 40 X 20 mm. and averaged 10 X 7 mm. Of the children 60% were treated while they were under neuroleptic anesthesia. No major complications were encountered. The 3-month rate free of stones after 1 treatment was 60% and increased to 80% with multiple treatments. The success rate, defined as being either free of stones or with residual fragments equal to or less than 4 mm. in diameter, was 95%. We conclude that lithotripsy with the Lithostar device in children, at least for the short term, is safe and effective.

A study of post-orchiectomy surveillance without radiation therapy was done in patients with histologically pure seminoma apparently confined to the testicle. Criteria for study entry included a negative physical examination, chest x-ray, bipedal lymphogram, excretory urogram, abdomino-pelvic computerized tomography scan and serum alpha-fetoprotein. Followup consisted of frequent clinical examination, repeat lymphograms, abdominal computerized tomography scans, chest x-rays and serum markers. The purpose of this study was to determine the percentage of patients cured by orchiectomy alone, percentage who ultimately required therapy for occult metastases beyond the testicle, sites of relapse, factors predictive of relapse, and over-all cure rate and treatment morbidity. Of 81 patients followed for 3 to 43 months (median 19 months) only 3 had relapse at 3, 5 and 18 months after orchiectomy with nonbulky retroperitoneal disease: 1 patient had disease 17 months after salvage infradiaphragmatic radiation therapy, 1 had an increase in beta-human chorionic gonadotropin 11 months after radiation therapy, presumably due to occult nonseminoma, and he is receiving chemotherapy, and 1 has not yet completed treatment. Further followup is necessary to determine ultimate survival, since a risk for later relapse exists. However, to date it does not appear as if the outcome has been compromised when surveillance was applied in place of routine adjuvant radiotherapy.

Incontinence in the elderly patient usually is of the urgency pattern owing to inappropriate detrusor contraction often termed detrusor instability. We herein describe a bladder volume-based method of urodynamic assessment that may help to characterize subsets of incontinent patients with detrusor instability. The conventional parameters of flow, pressure and electromyography are more difficult to measure and may be less appropriate for selection of therapy.

Multimodality treatments have increased the survival of cancer patients in recent years. With cure the quality of life also should be taken into consideration. Maintenance of the reproductive capacity is of great concern to many young patients. Until now the cause of sterility was attributed to the long-term side effects of treatment when recovery could not be predicted. Pre-treatment sperm banking is advised routinely for many of these patients. Our own observation as well as a few other reports show that cancer itself seems to have an adverse effect on fertility before any form of treatment. As assessed by semen quality the majority of our patients were subfertile when first seen. Hence, sperm banking may be a poor guarantee for future reproduction in these patients.

We analyzed the case histories of 31 patients who initially had a diagnosis of seminoma and elevated serum levels of alpha-fetoprotein or human chorionic gonadotropin. We concluded that an elevated alpha-fetoprotein level is firm evidence of the presence of non-seminomatous germ cell tumor and that the patient should be treated accordingly. However, if the level of human chorionic gonadotropin alone is elevated the diagnosis may be either non-seminomatous tumor or seminoma. Patients with seminoma and an elevated level of human chorionic gonadotropin do respond well to radiation therapy if they have low stage disease but if metastatic seminoma is present an elevated human chorionic gonadotropin level appears to be a poor prognostic sign if conventional treatment is given. A plan of treatment is proposed for these patients.

Patients with muscle invasive carcinoma of the bladder treated with radical radiation were prospectively documented and followed in an attempt to identify prognostic factors predictive of the response to treatment. Data on 121 consecutive patients treated with radical radiation between 1981 and 1985 are presented. Over-all actuarial survival of the patient population (median age 70 years) was 31.6% at 5 years and cause-specific survival was 44.8%. At analysis 33 of 121 patients (27.3%) were alive with preserved bladder function. Independent prognostic factors for cause-specific survival and for complete response with radical radiation were tumor configuration, hemoglobin level and clinical stage. The rate free of local relapse was significantly influenced by stage and presence of coexistent carcinoma in situ. The study suggests that factors other than stage and grade influence prognosis in invasive bladder cancer and should be considered in interpreting treatment results.

A case of infertility secondary to necrospermia was reinvestigated and reclassified as the "immotile cilia syndrome". The immotile spermatozoa were viable but motionless owing to an ultrastructural defect of the tail characterized by absence of microtubular dynein sidearms. There is no therapy for this congenital disorder and artificial insemination was performed.

We treated 41 patients with transitional cell carcinoma with methotrexate, vinblastine, doxorubicin and cisplatin chemotherapy. Median patient age was 56 years. Of the patients 33 had either distant metastases or locoregional disease that could not be cured by an operation or radiation. Of these patients 30 had measurable disease and 12 responded (4 complete and 8 partial responses, response rate 40 per cent, 95 per cent confidence limits 23 to 59 per cent). Only 2 of these patients remain with an unmaintained complete response at 34 and 52 months. Of 5 patients 3 responded who were treated with neoadjuvant methotrexate, vinblastine, doxorubicin and cisplatin for locally advanced bladder cancer before radiation or cystectomy, and only 1 of these patients is free of disease. The remaining 3 patients were treated postoperatively because they were at high risk for recurrence and all are well. Toxicity of the regimen was severe: 41 per cent of the patients experienced neutropenic sepsis and 54 per cent required hospitalization for management of toxic complications. Three patients experienced pulmonary embolism and 1 had deep vein thrombosis. There was 1 drug-related death of sepsis. Although a patient occasionally may have long-term benefit from this chemotherapy our results suggest caution in the widespread application of this protocol.

The principal morbidity of retroperitoneal lymphadenectomy is the potential loss of ejaculation and, therefore, fertility owing to damage of the retroperitoneal sympathetic nerves that form the superior hypogastric plexus. We describe the results of our retroperitoneal lymphadenectomy when individual nerves from the sympathetic ganglia are identified and preserved while still performing a thorough bilateral retroperitoneal lymphadenectomy. The nerve-sparing procedure was technically feasible in 20 of 30 consecutive patients and it was only impractical with extensive gross disease. Of the 20 patients 18 (90 per cent) ejaculate, including 8 with bulky (5 cm. or more) residual retroperitoneal disease who underwent a successful nerve-sparing operation. All 12 patients (100 per cent) with nonbulky disease ejaculate. With short followup, no retroperitoneal recurrences have been detected. This technique is an alternative to limited dissection designed to spare nerves using boundaries based on the patterns of metastatic involvement.