45 results on '"Klimberg, I."'
Search Results
2. Clinical Efficacy and Safety of Tolterodine Compared to Oxybutynin and Placebo in Patients with Overactive Bladder
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Drutz, H. P., Appell, R. A., Gleason, D., Klimberg, I., and Radomski, S.
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- 1999
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3. Early prostate cancer: is there a need for new treatment options?
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Klimberg, I, Locke, D.R, Madore, R.A, and Smith, W.W
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- 2003
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4. A dose response study of the effect of flutamide on benign prostatic hyperplasia; results of a multicenter study
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Narayan, P., Trachtenberg, J., Lepor, H., Debruyne, F.M.J., Tewari, A., Stone, N., Das, S., Jimenez Cruz, J.F., Shearer, R., Klimberg, I., Schellhammer, P.F., and Costelo, A.J.
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Clinical oncological research ,Klinisch Oncologisch Onderzoek - Abstract
Item does not contain fulltext 7 p.
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- 1996
5. Bicalutamide (‘Casodex’) 150 Mg as adjuvant to radical prostatectomy significantly increases progression-free survival in early prostate cancer: Evidence from a new analysis
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Fourcade, R.O., primary, Klimberg, I., additional, See, W.A., additional, Wirth, M.P., additional, McLeod, D.G., additional, Iversen, P., additional, and Garside, I., additional
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- 2003
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6. A multicenter comparison of oral lomefloxacin versus parenteral cefotaxime as prophylactic agents in transurethral surgery.
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Klimberg, I W, Childs, S J, Madore, R J, and Klimberg, S R
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ANTI-infective agents , *URINARY tract infection prevention , *CEFOTAXIME , *CLINICAL trials , *COMPARATIVE studies , *GENITOURINARY organs , *INTRAMUSCULAR injections , *INTRAVENOUS injections , *RESEARCH methodology , *MEDICAL cooperation , *ORAL drug administration , *PREANESTHETIC medication , *QUINOLONE antibacterial agents , *RESEARCH , *URETHRA , *URINARY tract infections , *EVALUATION research , *RANDOMIZED controlled trials , *THERAPEUTICS - Abstract
This report presents the pooled results from two randomized trials of lomefloxacin and cefotaxime used as prophylaxis in patients undergoing transurethral surgical procedures. A total of 499 patients were enrolled at seven centers in the United States. Patients received either 400 mg of lomefloxacin orally 2-6 hours prior to surgery, or 1 g of cefotaxime intravenously or intramuscularly 30-90 minutes preoperatively. Patients undergoing simple cystoscopy or retrograde pyelograms were not eligible for inclusion. Urine cultures were obtained prior to surgery, 24 hours post-surgery, prior to catheter removal, and 3-5 days post operatively. Treatment failure was defined as isolation of greater than or equal to 10(5) colony-forming units (CFU)/mL of pathogenic bacteria from any post-surgical urine culture. Lomefloxacin was successful in preventing post operative infections in 204 of 207 evaluable patients (98.6%); there were three prophylactic failures. Cefotaxime was successful in 196 of 206 (95.1%) evaluable patients; 10 were prophylactic failures. Lomefloxacin concentrations were measured simultaneously in serum and in samples of prostate tissue from 29 patients undergoing transurethral resection of the prostate. Lomefloxacin prostate concentrations were 1.0-22.3 micrograms/g, with a mean of 5.0 micrograms/g. The average tissue:plasma ratio was 2.0. The safety profile of the two study drugs was excellent, and both were well tolerated. Adverse events were reported by 12.7% of the patients treated with lomefloxacin and 13.8% of those treated with cefotaxime. The majority of events were mild and required no treatment. [ABSTRACT FROM AUTHOR]
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- 1992
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7. A new injectable bulking agent for treatment of stress urinary incontinence: results of a multicenter, randomized, controlled, double-blind study of Durasphere
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Lightner, D., Calvosa, C., Andersen, R., Klimberg, I., Brito, C. G., Snyder, J., Gleason, D., Killion, D., Macdonald, J., and Khan, A. U.
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- 2001
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8. Evaluation of an implant that delivers leuprolide for 1 year for the palliative treatment of prostate cancer
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Fowler, J. E., Flanagan, M., Gleason, D. M., Klimberg, I. W., Gottesman, J. E., and Sharifi, R.
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- 2000
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9. Single-Dose Oral Ciprofloxacin Versus Placebo for Prophylaxis During Transrectal Prostate Biopsy
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Kapoor, D. A., Klimberg, I. W., Malek, G. H., Wegenke, J. D., Cox, C. E., Patterson, A. L., Graham, E., Echols, R. M., Whalen, E., and Kowalsky, S. F.
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- 1998
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10. A Controlled Trial of Levofloxacin and Lomefloxacin in the Treatment of Complicated Urinary Tract Infection
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Klimberg, I. W., Cox, C. E., Fowler, C. L., King, W., Kim, Sun Sook, and Callery-D'Amico, S.
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- 1998
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11. A Multicenter, Double-Blind, Trimethoprim-Sulfamethoxazole Controlled Study of Enoxacin in the Treatment of Patients with Complicated Urinary Tract Infections
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Cox, C.E., Drylie, D.M., Klimberg, I., Childs, S.J., Wegenke, J.D., Malek, G.H., Harrison, L.H., McCullough, D.L., Finegold, S.M., George, W.L., Petersen, E.A., Paulson, D.F., Rigby, O.F., Markowitz, S.M., Crane, L.R., Siporin, C., and Wajszczuk, C.P.
- Abstract
In a double-blind, randomized, controlled trial, 249 patients with complicated urinary tract infections received either 400mg. enoxacin or 160mg. trimethoprim plus 800mg. sulfamethoxazole orally every 12hours for 14 days. The clinical outcome at the end of treatment revealed that all 89 evaluable patients (100 per cent) in the enoxacin group and 88 of 90 (98 per cent) in the trimethoprim-sulfamethoxazole group had satisfactory clinical responses (cure or improvement). Bacteriological effectiveness was measured cumulatively based on responses during and at the end of treatment, and 7 days later at followup. Satisfactory bacteriological responses (eradication or superinfection at all evaluations throughout the study) were achieved in significantly more (p equals 0.03) patients treated with enoxacin (93 per cent) than in those treated with trimethoprim-sulfamethoxazole (83 per cent). Both study medications were well tolerated. These results indicate that oral enoxacin was more effective clinically and bacteriologically (the latter statistically so) than trimethoprim-sulfamethoxazole when given as empiric therapy in the treatment of complicated urinary tract infections.
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- 1989
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12. Intraoperative autotransfusion in urologic oncology
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Klimberg, I., primary
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- 1986
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13. The Prognostic Value of the Pathological Response to Combination Chemotherapy before Cystectomy in Patients with Invasive Bladder Cancer
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Splinter, T.A.W., Scher, H.I., Denis, L., Bukowski, R., Simon, S., Klimberg, I., Soloway, M., Vogelzang, N.J., Van Tinteren, H., and Herr, H.
- Abstract
The prognostic value of the pathological response to combination chemotherapy of deeply invasive transitional cell cancer of the bladder was retrospectively assessed in 147 patients. Data were collected from 8 different centers. Patients were eligible if they had received intravenous combination chemotherapy followed by partial, total or radical cystectomy, and if they had a minimum followup of 2 years after the start of chemotherapy. Of the patients 90% received methotrexate, vinblastine, doxorubicin and cisplatin (M-VAC) or cisplatin plus methotrexate for a median of 3 courses (range 1 to 6). Of the 83 patients who were alive at analysis actuarial median followup was 30.5 months (range 13.2 to 85.6 months). A major pathological response (stage P0, Pis, Pa or P1) was achieved in 41.5% of the patients. Patients with a major pathological response (p stage less than 2) had a 5-year survival of 75% in contrast to 20% for the remaining nonresponding patients (p stage 2 or more). The survival of patients with a major pathological response was independent of whether the response was induced by 2 or more courses of chemotherapy, or whether it was induced by M-VAC in comparison with cisplatin plus methotrexate. Preoperative clinical assessments can identify nonresponding patients correctly and in these cases alternative treatment programs are required, since 80% will die of the disease. Moreover, if neoadjuvant chemotherapy is proved to increase survival, the data emphasize the importance of the response rate of the primary tumor and the need to investigate the optimal number of courses to induce the best response, preferably in the individual patient.
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- 1992
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14. Denosumab in men receiving androgen-deprivation therapy for prostate cancer
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Blair Egerdie, Teuvo L.J. Tammela, Jiri Heracek, Amy Kupic, Robert G. Feldman, Maciej Szwedowski, Carsten Goessl, Fred Saad, Benjamin Z. Leder, Chunlei Ke, Narciso Hernández Toriz, Matthew R. Smith, Denosumab HALT Prostate Cancer Study Group, Agus, D., Aronoff, D., Axler, M., Baker, K., Brosman, S., Chang, S., Charu, V., Chodak, G., Chu, F., Cochran, J., Colombo, G., Dhillon, G., Dineen, M., Dula, E., Efros, M., Ekbal, S., Feldman, R.G., Fisher, H., Friedel, W., Gittelman, M., Gleason, D., Goldberg, K., Goldfischer, E., Gopalakrishnan, G., Greengold, R., Grossfeld, G., Hahn, N., Hale, B., Hassman, D., Hopkins, S., Iranmanesh, A., Israeli, R., Jepson, B., Jones, W., Kagan, R., Karlin, G., Katz, J., Kaufman, J., Keiller, D., Kim, D., Klimberg, I., Kramolowsky, E., Lanctin, H., Lilly, J., Lugg, J., Lumerman, J., Madorsky, M., McMurray, J., Mehlhaff, B., Mellinger, B., Modiano, M., Moseley, W., Murdock, M., Penson, D., Reed, D., Roberts, B., Saltzstein, D., Sharkey, J., Shepherd, D., Sidhom, A., Sieber, P., Sipio, J., Smith, R., Smith, F., Steidle, C., Tchekmedyian, S., Teigland, C., Thrasher, J., Tomera, K., Updegrove, J., Wachs, B., Wells, W.G., Whitlock, N., Williams, R., Wurzel, R., Yee, L., Aaron, L., Andreou, C., Barkin, J., Bora, B., Buckley, R., Casey, R., Chetner, M., Chin, J., DiConstanzo, G., Donnelly, B., Flax, S., Gleave, M., Goldfarb, B., Hewitt, R., Hirshberg, E., Jansz, K., Kapoor, A., Kinahan, T., Klotz, L., Lacombe, L., Leung, W., Liquornik, M., Love, W., Mathur, A., Morash, C., Okafo, B., Palmer, B., Pommerville, P., Siemens, D.R., Steinhoff, G., Tanguay, S., Trachtenberg, J., Woods, E., Zadra, J., Cruz-Rodriguez, M., Galicia-Samano, R., Hernandez-Ordonez, O., Martinez-Martinez, C., Robles-Avina, J., Octavio-Rovelo-Diaz, C., Suarez-Sahui, T., Vargas-Zamora, H., Bar, K., Darewicz, B., Demkow, T., Jablonska, Z., Jarzemski, P., Kania, P., Niezabitowski, J., Pypno, W., Szwedowski, R., Hanus, M., Hesoun, P., Jansa, J., Pacik, D., Pernicka, J., Richter, J., Urban, M., Zmeskal, P., Barten, E., van den Broeke, P.J., Bruins, J.L., Khoe, G., Kil, P.J., Meier, A.H., van Berkel, J., Body, G., Kondas, J., Koranyi, L., Tenke, P., Torzsok, F., Toth, T., Lamy, O., Lippuner, K., Theiler, R., and Leppilahti, M.
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Bone mineral ,medicine.medical_specialty ,Bone density ,business.industry ,Osteoporosis ,General Medicine ,Aged ,Aged, 80 and over ,Androgen Antagonists/adverse effects ,Androgen Antagonists/therapeutic use ,Antibodies, Monoclonal/adverse effects ,Antibodies, Monoclonal/pharmacology ,Antibodies, Monoclonal/therapeutic use ,Antibodies, Monoclonal, Humanized ,Bone Density/drug effects ,Bone Density Conservation Agents/adverse effects ,Bone Density Conservation Agents/pharmacology ,Bone Density Conservation Agents/therapeutic use ,Bone Remodeling/drug effects ,Denosumab ,Double-Blind Method ,Fractures, Bone/epidemiology ,Fractures, Bone/prevention & control ,Gonadotropin-Releasing Hormone/agonists ,Humans ,Incidence ,Injections, Subcutaneous ,Lumbar Vertebrae/drug effects ,Lumbar Vertebrae/injuries ,Lumbar Vertebrae/physiology ,Male ,Middle Aged ,Orchiectomy ,Osteoporosis/chemically induced ,Osteoporosis/drug therapy ,Prostatic Neoplasms/drug therapy ,Prostatic Neoplasms/physiopathology ,Prostatic Neoplasms/surgery ,RANK Ligand/adverse effects ,RANK Ligand/pharmacology ,RANK Ligand/therapeutic use ,Spinal Fractures/epidemiology ,Spinal Fractures/prevention & control ,medicine.disease ,Article ,Bone remodeling ,Surgery ,Androgen deprivation therapy ,Prostate cancer ,medicine.anatomical_structure ,medicine ,business ,Femoral neck ,medicine.drug - Abstract
Androgen-deprivation therapy is well-established for treating prostate cancer but is associated with bone loss and an increased risk of fracture. We investigated the effects of denosumab, a fully human monoclonal antibody against receptor activator of nuclear factor-kappaB ligand, on bone mineral density and fractures in men receiving androgen-deprivation therapy for nonmetastatic prostate cancer. In this double-blind, multicenter study, we randomly assigned patients to receive denosumab at a dose of 60 mg subcutaneously every 6 months or placebo (734 patients in each group). The primary end point was percent change in bone mineral density at the lumbar spine at 24 months. Key secondary end points included percent change in bone mineral densities at the femoral neck and total hip at 24 months and at all three sites at 36 months, as well as incidence of new vertebral fractures. At 24 months, bone mineral density of the lumbar spine had increased by 5.6% in the denosumab group as compared with a loss of 1.0% in the placebo group (P
- Published
- 2009
15. Multicenter prospective randomized 52-week trial of calcium hydroxylapatite versus bovine dermal collagen for treatment of stress urinary incontinence.
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Mayer RD, Dmochowski RR, Appell RA, Sand PK, Klimberg IW, Jacoby K, Graham CW, Snyder JA, Nitti VW, and Winters JC
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- Adult, Aged, Animals, Cattle, Cross-Over Studies, Female, Follow-Up Studies, Humans, Middle Aged, Probability, Prospective Studies, Reference Values, Risk Assessment, Single-Blind Method, Treatment Outcome, Urinary Incontinence, Stress diagnosis, Urodynamics, Collagen therapeutic use, Durapatite therapeutic use, Quality of Life, Urinary Incontinence, Stress therapy
- Abstract
Objectives: To evaluate the safety and effectiveness of soft-tissue augmentation of the urethral sphincter with calcium hydroxylapatite (CaHA; Coaptite) compared with glutaraldehyde cross-linked bovine collagen (Contigen) in female patients with stress urinary incontinence due to intrinsic sphincter deficiency and without associated urethral hypermobility., Methods: This 12-month prospective, randomized, comparative, multicenter, single-blind, parallel, clinical trial of CaHA and collagen for soft-tissue augmentation of the urethral sphincter in the treatment of stress urinary incontinence enrolled 296 women. Up to five injections were performed in the first 6 months of the trial. Twelve-month postinjection efficacy data were available for 231 patients., Results: The results indicated that CaHA and collagen were both well tolerated in this study. No systemic adverse events were observed with either product. We used the Stamey Urinary Incontinence Scale to grade the improvement, which was the primary endpoint of the study. At 12 months, 83 (63.4%) of 131 CaHA patients compared with 57 (57.0%) of 100 collagen patients showed improvement of one Stamey grade or more (P = 0.34). More CaHA patients required only one injection (n = 60; 38.0%) during the study compared with the Contigen patients (n = 36; 26.1%; P = 0.034). Also, the average total volume of material injected during the course of the study was less for CaHA than for collagen (4.0 mL versus 6.6 mL, respectively; P <0.0001)., Conclusions: The results of the study have demonstrated that Coaptite is an appropriate and well-tolerated treatment for patients with incontinence due to intrinsic sphincter deficiency. This new soft-tissue augmentation material has a good safety profile and appears to provide durable improvement.
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- 2007
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16. The bicalutamide 150 mg early prostate cancer program: findings of the North American trial at 7.7-year median followup.
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McLeod DG, See WA, Klimberg I, Gleason D, Chodak G, Montie J, Bernstein G, Morris C, and Armstrong J
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- Adult, Aged, Aged, 80 and over, Androgen Antagonists adverse effects, Anilides adverse effects, Antineoplastic Agents, Hormonal adverse effects, Combined Modality Therapy, Disease Progression, Disease-Free Survival, Double-Blind Method, Follow-Up Studies, Humans, Male, Middle Aged, Nitriles, Prostatic Neoplasms mortality, Survival Rate, Tosyl Compounds, Androgen Antagonists administration & dosage, Anilides administration & dosage, Antineoplastic Agents, Hormonal administration & dosage, Prostatic Neoplasms therapy
- Abstract
Purpose: We describe the results of North American Trial 23 of the bicalutamide (Casodex) early prostate cancer program in the context of the overall early prostate cancer program findings., Materials and Methods: In Trial 23, 3,292 men with T1b-4, N0-Nx (N+ not allowed) M0 prostate cancer who had undergone radical prostatectomy or radiotherapy at 96 specialist referral centers in the United States (2,974) and Canada (318) were randomized 1:1 to 150 mg bicalutamide daily or placebo in addition to standard care for 2 years., Results: In Trial 23 at a 7.7-year median followup there were few clinical events in the bicalutamide or standard care groups and the rates of objective progression were 15.4% and 15.3%, respectively. Mortality rates were 12.9% in the treatment group and 12.3% in the standard care group, including 11.2% and 11.0% for nonprostate cancer deaths in the absence of objective progression and 1.6% and 0.9%, respectively, for mortality due to prostate cancer. No differences in the primary end points (objective progression-free and overall survival) were seen between patients treated with bicalutamide and those treated with standard care alone. Bicalutamide (150 mg) significantly improved time to PSA progression (HR 0.80, 95% CI 0.72 to 0.90, p <0.001). The tolerability profile of bicalutamide was similar to that previously described., Conclusions: In Trial 23 the current data suggest that early or adjuvant therapy may not benefit patients at low risk for recurrence, such as those with localized disease. The findings of Trial 23 contrast with the results in the overall early prostate cancer program and in other published literature, in which bicalutamide has been shown to provide significant clinical benefit for locally advanced disease.
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- 2006
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17. Time to symptom relief for uncomplicated urinary tract infection treated with extended-release ciprofloxacin: a prospective, open-label, uncontrolled primary care study.
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Klimberg I, Shockey G, Ellison H, Fuller-Jonap F, Colgan R, Song J, Keating K, and Cyrus P
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- Acute Disease, Adolescent, Adult, Aged, Anti-Infective Agents administration & dosage, Anti-Infective Agents adverse effects, Ciprofloxacin administration & dosage, Ciprofloxacin adverse effects, Delayed-Action Preparations, Female, Humans, Middle Aged, Prospective Studies, Surveys and Questionnaires, Time Factors, Treatment Outcome, Urinary Tract Infections physiopathology, Anti-Infective Agents therapeutic use, Ciprofloxacin therapeutic use, Urinary Tract Infections drug therapy
- Abstract
Objective: Few studies have investigated symptom relief in urinary tract infections. This innovative exploratory trial aimed to measure the time to improvement of the signs and symptoms of uncomplicated urinary tract infection (UTI) in women receiving extended-release ciprofloxacin. Time to return to normal daily activities was also evaluated., Research Design and Methods: An open-label, multicenter US study in adult female outpatients with uncomplicated UTI. Patients completed serial questionnaires: the Urinary tract infection Symptom Assessment [USA], tracking time to symptom improvement, and the Activity Impairment Assessment [AIA], measuring the time to return to normal daily activities, using hand-held electronic diaries. Severity on the USA questionnaire was categorized using a 4-point Likert-type scale, with improvement defined as a reduction of at least one degree of symptom severity. All patients received once-daily extended-release ciprofloxacin 500 mg tablets for 3 days., Results: Of 276 female patients aged 18-78 years who enrolled at 28 sites, 273 (99%) were safety-valid, 264 (96%) completed at least 24 h of questionnaires and were valid for symptom relief analysis, and 170 (62%) had pre-therapy pathogen(s) > or = 10(3) CFU/mL and were valid for efficacy analysis. Six hours after the first dose of study drug, 50% of patients reported symptom improvement; 87% by 24 h and 91% by 48 h. At study entry, 54% of patients reported considerably decreased time at work or other activities; reduced to 23% by Day 2 and 10% by Day 3. At the test-of-cure visit (5-11 days post-therapy), 96% (163/170) of patients were clinical cures. Drug-related adverse events were reported by 18 (7%) patients and were consistent with previous extended-release ciprofloxacin studies (e.g., gastrointestinal disturbance, fungal superinfections). There were no serious adverse events or discontinuations due to adverse events., Conclusion: This open-label, non-comparative trial in adult women demonstrated a rapid improvement in uncomplicated UTI symptom severity (6-24 h) and the ability to return to work within 24 h following extended-release ciprofloxacin treatment. Clinical cure rate and tolerability profile were similar to results of previous extended-release ciprofloxacin studies.
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- 2005
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18. Is the efficacy of hormonal therapy affected by lymph node status? data from the bicalutamide (Casodex) Early Prostate Cancer program.
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Iversen P, Wirth MP, See WA, McLeod DG, Klimberg I, Gleason D, Chodak G, Montie J, Tyrrell C, Wallace DM, Delaere KP, Lundmo P, Tammela TL, Johansson JE, Morris T, and Carroll K
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- Adult, Aged, Aged, 80 and over, Androgen Antagonists therapeutic use, Disease Progression, Humans, Lymphatic Metastasis pathology, Male, Middle Aged, Neoplasm Staging, Nitriles, Prostate-Specific Antigen blood, Prostatectomy, Prostatic Neoplasms blood, Regression Analysis, Tosyl Compounds, Anilides therapeutic use, Antineoplastic Agents therapeutic use, Prostatic Neoplasms pathology, Prostatic Neoplasms therapy
- Abstract
Objectives: To report an exploratory subgroup analysis assessing the extent to which the overall benefit found in the Early Prostate Cancer program is dependent on lymph node status at randomization. The program is ongoing, and the overall survival data are immature. The first combined analysis of the bicalutamide (Casodex) Early Prostate Cancer program at 3 years' median follow-up showed that bicalutamide, 150 mg once daily, plus standard care (radical prostatectomy, radiotherapy, or watchful waiting), significantly reduced the risk of objective progression and prostate-specific antigen (PSA) doubling in patients with localized/locally advanced prostate cancer., Methods: Men (n = 8113) with localized/locally advanced disease received bicalutamide 150 mg or placebo once daily, plus standard care. The time to event data (objective progression, PSA doubling) was analyzed by lymph node status at randomization., Results: Compared with standard care alone, bicalutamide significantly reduced the risk of objective progression, irrespective of lymph node status, with the most pronounced reduction in patients with N+ (hazard ratio [HR] 0.29; 95% confidence interval [CI] 0.15 to 0.56) compared with those with N0 (HR 0.59; 95% CI 0.48 to 0.73) and Nx (HR 0.60; 95% CI 0.50 to 0.72) disease. The largest decrease in risk of PSA doubling with bicalutamide was observed in N+ disease (HR 0.16; 95% CI 0.09 to 0.29), with significantly reduced risks seen in N0 (HR 0.45; 95% CI 0.40 to 0.51) and Nx (HR 0.38; 95% CI 0.33 to 0.44) disease., Conclusions: The greatest reduction in the risk of objective progression and PSA doubling with bicalutamide was seen in patients with N+ disease. However, bicalutamide also provided a statistically significant benefit in those with N0 and Nx disease.
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- 2004
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19. Bicalutamide as immediate therapy either alone or as adjuvant to standard care of patients with localized or locally advanced prostate cancer: first analysis of the early prostate cancer program.
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See WA, Wirth MP, McLeod DG, Iversen P, Klimberg I, Gleason D, Chodak G, Montie J, Tyrrell C, Wallace DM, Delaere KP, Vaage S, Tammela TL, Lukkarinen O, Persson BE, Carroll K, and Kolvenbag GJ
- Subjects
- Adult, Aged, Aged, 80 and over, Androgen Antagonists adverse effects, Anilides adverse effects, Antineoplastic Agents adverse effects, Chemotherapy, Adjuvant, Combined Modality Therapy, Disease Progression, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Humans, Male, Middle Aged, Neoplasm Staging, Nitriles, Prostatic Neoplasms mortality, Prostatic Neoplasms pathology, Survival Rate, Tosyl Compounds, Androgen Antagonists administration & dosage, Anilides administration & dosage, Antineoplastic Agents administration & dosage, Prostatic Neoplasms drug therapy
- Abstract
Purpose: We determine the efficacy and tolerability of bicalutamide as immediate therapy, either alone or as adjuvant to treatment of curative intent, in patients with clinically localized or locally advanced prostate cancer., Materials and Methods: This international program consists of 3 ongoing, randomized, double-blind, placebo controlled clinical trials (trials 23, 24, and 25). Men with localized or locally advanced (T1-T4, Nx/N0, M0) prostate cancer were randomized to receive 150 mg. bicalutamide daily or placebo, in addition to standard care with radical prostatectomy, radiotherapy or watchful waiting. Primary end points are time to objective progression and overall survival. In this first analysis data from the trials were combined in a single overview analysis according to protocol., Results: Data are available for 8,113 patients (4,052 randomized to bicalutamide, 4,061 to standard care alone) at a median followup of 3.0 years. Treatment with bicalutamide provided a highly significant reduction of 42% in the risk of objective progression compared with standard care alone (9.0% versus 13.8%, hazards ratio 0.58; 95% confidence interval 0.51, 0.66; p <<0.0001). The overall result was reflected in 2 of the 3 trials (trials 24 and 25) with trial 3 (trial 23) showing a nonsignificant difference at this time. Reductions in the risk of disease progression were seen across the entire patient population, irrespective of primary treatment or disease stage. Overall survival data are currently immature and longer followup will determine if there is also a survival benefit with bicalutamide. The most frequently reported side effects of bicalutamide were gynecomastia and breast pain., Conclusions: Immediate treatment with 150 mg. bicalutamide daily, either alone or as adjuvant to treatment of curative intent, significantly reduces the risk of disease progression in patients with localized or locally advanced prostate cancer. This benefit must be balanced with the morbidity associated with long-term hormonal therapy. Followup is ongoing to determine potential survival benefits of this treatment approach.
- Published
- 2002
20. Randomized trial of a combination of natural products (cernitin, saw palmetto, B-sitosterol, vitamin E) on symptoms of benign prostatic hyperplasia (BPH).
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Preuss HG, Marcusen C, Regan J, Klimberg IW, Welebir TA, and Jones WA
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- Double-Blind Method, Humans, Male, Prostatic Hyperplasia physiopathology, Secale, Serenoa, Urodynamics, Androgen Antagonists therapeutic use, Biological Products therapeutic use, Plant Extracts therapeutic use, Prostatic Hyperplasia therapy, Sitosterols therapeutic use, Vitamin E therapeutic use
- Abstract
Because benign prostatic hyperplasia (BPH) is relatively common, it is important to discover safe and effective means to treat this often debilitating perturbation. Accordingly, we examined the effectiveness of a combination of natural products (cernitin, saw palmetto, B-sitosterol, vitamin E) in treating symptoms of BPH. We undertook a randomized, placebo-controlled, double-blind study. Patients were enrolled from 3 urological practices in the USA. 144 subjects were randomized for study. 17 subjects eventually withdrew, leaving 70 patients in the test group and 57 in the placebo group to complete the study. Inclusion criteria consisted of a diagnosis of BPH, no evidence of cancer, and a maximal urinary flow rate between 5 and 15 ml/second. Patients received either placebo or the combined natural products for 3 months. Evaluations were performed via the American Urological Association (AUA) Symptom Index score, urinary flow rate, PSA measurement, and residual bladder volume. Nocturia showed a markedly significant decrease in severity in patients receiving the combined natural products compared to those taking placebo (p < 0.001). Daytime frequency was also lessened significantly (p < 0.04). When the average individual total AUA Symptom Index score in the test group was compared to that in the placebo group at the end of the study, the difference proved highly significant (p < 0.014). PSA measurements, maximal and average urinary flow rates, and residual volumes showed no statistically significant differences. When taken for 3 months, a combination of natural products (cernitin, saw palmetto, B-sitosterol, vitamin E) compared to placebo can significantly lessen nocturia and frequency and diminish overall symptomatology of BPH as indicated by an improvement in the total AUA Symptom Index score. The combination of natural products caused no significant adverse side effects.
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- 2001
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21. Single-dose oral ciprofloxacin compared with cefotaxime and placebo for prophylaxis during transurethral surgery.
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Klimberg IW, Malek GH, Cox CE, Patterson AL, Whalen E, Kowalsky SF, and Echols RM
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- Administration, Oral, Adult, Aged, Double-Blind Method, Female, Humans, Male, Middle Aged, Placebos, Anti-Infective Agents therapeutic use, Bacteriuria prevention & control, Cefotaxime therapeutic use, Cephalosporins therapeutic use, Ciprofloxacin therapeutic use, Prostatectomy adverse effects
- Abstract
To determine the efficacy and safety of single-dose oral ciprofloxacin prophylaxis for the prevention of post-operative bacteriuria following transurethral resection of the prostate or bladder tumour, a prospective, randomized, double-blind, placebo-controlled trial was conducted. Five hundred and eighteen patients were randomized in a 2:2:1 ratio to receive ciprofloxacin 500 mg, cefotaxime 1 g or placebo 30-90 min before surgery. Of the 368 efficacy-evaluable patients, five (3.3%) ciprofloxacin, seven (4.8%) cefotaxime and five (7.0%) placebo recipients had post-operative bacteriuria (> or = 10(4) cfu/mL) during post-operative days 2-15. Five (3.4%) ciprofloxacin, five (3.4%) cefotaxime and one (2.4%) placebo recipients were considered clinical failures, of whom one, two and one patients, respectively, had concomitant bacteriuria. Drug-related adverse events were reported in six of 204 (3%) ciprofloxacin, 12 of 197 (6%) cefotaxime and one of 101 (1%) placebo patients. The observed rates of post-operative bacteriuria suggest that a single 500 mg dose of ciprofloxacin is suitable prophylaxis for transurethral surgery.
- Published
- 1999
22. A trial comparing low-dose, short-course ciprofloxacin and standard 7 day therapy with co-trimoxazole or nitrofurantoin in the treatment of uncomplicated urinary tract infection.
- Author
-
Iravani A, Klimberg I, Briefer C, Munera C, Kowalsky SF, and Echols RM
- Subjects
- Acute Disease, Adolescent, Adult, Aged, Aged, 80 and over, Anti-Infective Agents adverse effects, Anti-Infective Agents, Urinary adverse effects, Ciprofloxacin adverse effects, Cystitis drug therapy, Cystitis microbiology, Dose-Response Relationship, Drug, Double-Blind Method, Escherichia coli Infections drug therapy, Female, Humans, Middle Aged, Nitrofurantoin adverse effects, Prospective Studies, Staphylococcal Infections drug therapy, Streptococcal Infections drug therapy, Trimethoprim, Sulfamethoxazole Drug Combination adverse effects, Urinary Tract Infections microbiology, Anti-Infective Agents therapeutic use, Anti-Infective Agents, Urinary therapeutic use, Ciprofloxacin therapeutic use, Nitrofurantoin therapeutic use, Trimethoprim, Sulfamethoxazole Drug Combination therapeutic use, Urinary Tract Infections drug therapy
- Abstract
The study was undertaken to compare the safety and efficacy of twice-daily ciprofloxacin for 3 days with standard 7 day therapy with either co-trimoxazole or nitrofurantoin in the treatment of women with acute, uncomplicated urinary tract infections (UTI). This multicentre, prospective, randomized, double-blind trial compared oral ciprofloxacin (100 mg bd) for 3 days with co-trimoxazole (160/800 mg bd) or nitrofurantoin (100 mg bd) for 7 days. Bacteriological and clinical evaluations were performed at study entry, during therapy and 4-10 days and 4-6 weeks after the completion of therapy. The primary efficacy parameter was eradication of the causative organism 4-10 days following treatment. Of 713 women enrolled and evaluable for safety, 521 were evaluable for efficacy (168 ciprofloxacin, 174 co-trimoxazole, 179 nitrofurantoin). Escherichia coli (83%) was the most frequently isolated pathogen in all treatment groups. Bacteriological eradication was reported in 88% of ciprofloxacin patients, 93% of co-trimoxazole patients and 86% of nitrofurantoin patients. At the 4-6 week follow-up, ciprofloxacin had statistically significantly higher eradication rates (91%) than co-trimoxazole (79%; 95% confidence limit (CL) = -20.6%, -3.9%) and nitrofurantoin (82%; 95% CL = -17.1%, -0.9%). Clinical resolution 4-10 days after therapy and at the 4-6 week follow-up was similar among the three treatment groups. The overall incidence of treatment-emergent adverse events was not significantly different (P = 0.093) among the three drug regimens, although co-trimoxazole was associated with a greater number of adverse events than ciprofloxacin (P < or = 0.05). Ciprofloxacin also caused fewer episodes of nausea than either of the other agents (P < or = 0.01).
- Published
- 1999
23. Levofloxacin versus ciprofloxacin versus lomefloxacin in acute pyelonephritis.
- Author
-
Richard GA, Klimberg IN, Fowler CL, Callery-D'Amico S, and Kim SS
- Subjects
- Acute Disease, Adolescent, Adult, Aged, Aged, 80 and over, Female, Humans, Male, Middle Aged, Pyelonephritis microbiology, Anti-Infective Agents therapeutic use, Ciprofloxacin therapeutic use, Levofloxacin, Ofloxacin therapeutic use, Pyelonephritis drug therapy
- Abstract
Objectives: To evaluate, in two randomized, multicenter trials, levofloxacin compared with ciprofloxacin and lomefloxacin for efficacy and safety in treating acute pyelonephritis., Methods: We enrolled a total of 186 patients with bacteriologically proved infection. Of these, 89 patients in both trials combined received levofloxacin 250 mg once daily; 58 received ciprofloxacin 500 mg twice daily in the first trial (double blind); and 39 received lomefloxacin 400 mg once daily in the second trial (open label). Microbiologic response of patients evaluable for microbiologic efficacy was the primary efficacy variable, and clinical response of microbiologically evaluable patients was the secondary efficacy variable in both studies., Results: Escherichia coli was the most prevalent pathogen. At 5 to 9 days after the end of treatment, 95% of uropathogens were eradicated in patients who received levofloxacin compared with 94% in the ciprofloxacin-treated group and 95% in the lomefloxacin-treated group. The clinical cure rate was 92% for levofloxacin in both studies combined, 88% for ciprofloxacin, and 80% for lomefloxacin. Drug-related adverse events were reported by 2% of levofloxacin-treated patients, 8% of ciprofloxacin-treated patients, and 5% of lomefloxacin-treated patients., Conclusions: The once-daily oral administration, proven efficacy, and good tolerability make levofloxacin an excellent choice for empiric treatment of acute pyelonephritis.
- Published
- 1998
- Full Text
- View/download PDF
24. Doxazosin for benign prostatic hyperplasia: long-term efficacy and safety in hypertensive and normotensive patients. The Multicenter Study Group.
- Author
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Lepor H, Kaplan SA, Klimberg I, Mobley DF, Fawzy A, Gaffney M, Ice K, and Dias N
- Subjects
- Aged, Aged, 80 and over, Humans, Hypertension complications, Male, Middle Aged, Prostatic Hyperplasia complications, Time Factors, Antihypertensive Agents therapeutic use, Doxazosin therapeutic use, Hypertension drug therapy, Prostatic Hyperplasia drug therapy
- Abstract
Purpose: We evaluated the sustained efficacy and safety of doxazosin for long-term treatment (up to 48 months) of normotensive and hypertensive patients with benign prostatic hyperplasia (BPH)., Materials and Methods: A total of 272 normotensive and 178 mildly to moderately hypertensive men entered a long-term extension study of doxazosin therapy (1 to 8 and 1 to 12 mg. 1 time daily, respectively) for BPH following participation in double-blind, placebo controlled studies. The starting dose of doxazosin was 1 mg. with upward titrations at 2-week intervals to a stable, efficacious and well tolerated dose. At the time of data analysis patients had received between 1 and 48 months of stable dose doxazosin therapy (mean 668 days for normotensive and 807 for hypertensive patients). Mean daily doses were 4 and 6.4 mg. for normotensive and hypertensive men, respectively., Results: At the end point analysis doxazosin treatment resulted in significant increases above baseline in maximum and average urinary flow rates (1.9 and 1.0 ml. per second, respectively). As assessed by the patient, total, obstructive and irritative BPH symptoms also improved significantly with doxazosin treatment. In the 28 patients who completed 45 to 48 months of treatment improvement in symptom bothersomeness (13.2%) was similar to that of the overall group at the end point (14.8%). Sustained blood pressure decreases (approximately 8/11 mm. Hg systolic/diastolic blood pressure) with doxazosin were statistically and clinically significant in hypertensive patients. Blood pressure decreases in normotensive patients were not clinically significant (approximately 4/2 mm. Hg) and few withdrew from study for reasons related directly to decreased blood pressure or hypotension. Changes in heart rate were not significant. Doxazosin was well tolerated with almost 90% of adverse experiences considered mild or moderate in severity. The most common adverse events were dizziness, headache and fatigue in normotensive and hypertensive patients., Conclusions: In this study long-term doxazosin treatment was significantly effective and well tolerated for treating BPH in normotensive and hypertensive patients.
- Published
- 1997
- Full Text
- View/download PDF
25. A dose-response study of the effect of flutamide on benign prostatic hyperplasia: results of a multicenter study.
- Author
-
Narayan P, Trachtenberg J, Lepor H, Debruyne FM, Tewari A, Stone N, Das S, Jimenez-Cruz JF, Shearer R, Klimberg I, Schellhammer PF, and Costello AJ
- Subjects
- Aged, Androgen Antagonists adverse effects, Androgen Antagonists therapeutic use, Dose-Response Relationship, Drug, Double-Blind Method, Flutamide adverse effects, Flutamide therapeutic use, Humans, Male, Middle Aged, Prostatic Hyperplasia physiopathology, Treatment Outcome, Urodynamics, Androgen Antagonists administration & dosage, Flutamide administration & dosage, Prostatic Hyperplasia drug therapy
- Abstract
Objectives: The objective of this study was to evaluate efficacy, safety, and dose-response profiles of four dosing schemes of flutamide over 24 weeks., Methods: Patients were randomized to receive one of the following five treatment regimens for a period of 24 weeks: placebo capsule, flutamide capsules 125 mg twice daily, 250 mg once daily, 250 mg twice daily, and 250 mg three times daily. Patients were then evaluated at baseline (0 weeks) and at 4, 6, 12, 18, and 24 weeks after the start of treatment, and 8 weeks after the end of treatment (32 weeks). Evaluation of efficacy was performed by noting changes in urine flow rate, residual urine volume, symptom score, prostate volume, and prostate-specific antigen level. A total of 372 patients were enrolled into the study at 32 centers (14 centers in the United States and 18 international centers)., Results: Baseline peak urinary flow rate and percent change from baseline in maximum flow rate showed a dose-related increase at 4 and 6 weeks; this increase was significant in the 250 mg three times daily group. At later time points, no significant differences between the flutamide and placebo groups were observed, largely because of the decreasing number of evaluable patients. At 4 and 6 weeks, 25% of patients in the 250 mg three times daily group had more than 3 cc/s increase in uroflow compared to about 10% of placebo patients (P < 0.05). All flutamide-treated groups had a significant decrease in prostate volume from baseline to the last treatment visit compared to placebo and this reduction was dose related (in comparison to placebo: P < 0.05 for 125 mg twice daily and P < 0.001 for all other treatment arms). Median decrease for the flutamide-treated groups ranged from 6% to 23% at 12 weeks and from 14% to 29% at 24 weeks. All treatment groups showed a subsequent increase in prostate volume after treatment was stopped. Furthermore, there was a significant reduction in residual urine volume at 24 weeks only in the 250 mg three times daily group. It increased following cessation of therapy. Urinary symptoms at 6, 12, 18, and 24 weeks did not show any significant difference between placebo and any flutamide dose group. The most common adverse events were nipple and breast tenderness (42% to 52%), diarrhea (29% to 34%), and gynecomastia (14% to 19%). Each of these adverse events had a significantly higher incidence in all flutamide dose groups compared with placebo, but none appeared to occur in a dose-related fashion. Sixteen percent of patients in the placebo group and 25% to 39% of patients in flutamide groups were discontinued due to diarrhea (12% to 17%) or nipple and breast tenderness (4% to 8%). A total of 1% to 3% of patients in various treatment arms discontinued due to deranged liver enzymes (1% for placebo); and 1% to 4% due to impotence (1% for placebo)., Conclusions: Flutamide reduced the prostate volume in a dose-related fashion and resulted in an increase in peak flow rate at 4 weeks (3% for 250 mg three times daily, P value < 0.05), but the early positive effects did not maintain statistical significance due to an increasing number of dropouts due to adverse events. Effect on postvoid residual volume was observed only at the highest dose and at 24 weeks (median reduction, 23 mL, P < 0.05). Despite volume reduction and early improvement in peak flow rate, there were no significant differences in urinary symptoms among the placebo and flutamide groups. Higher incidences of diarrhea, breast tenderness, and gynecomastia, however, were the main limiting factors in this study and until these problems are overcome, the role of flutamide in the management of benign prostatic hyperplasia remains investigational.
- Published
- 1996
- Full Text
- View/download PDF
26. Outpatient transurethral resection of the prostate at a urological ambulatory surgery center.
- Author
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Klimberg IW, Locke DR, Leonard E, Madore R, and Klimberg SR
- Subjects
- Adult, Aged, Aged, 80 and over, Humans, Male, Middle Aged, Postoperative Complications epidemiology, Postoperative Complications therapy, Ambulatory Surgical Procedures, Prostatectomy, Prostatic Hyperplasia surgery
- Abstract
Transurethral resection of the prostate has been the standard treatment for patients with benign prostatic hyperplasia, and it has traditionally required 2 to 7 days of hospitalization. Since 1991 we performed outpatient transurethral resection of the prostate at a urological ambulatory surgery center on 125 select patients. Standard resection techniques were used with particular attention to hemostasis, since bladder irrigation was stopped before patients were discharged home. Transfer to a hospital was required for 3 patients because of hematuria, 1 for fever and suspected bacteremia, and 1 for cardiac dysrhythmia. No patient required hospitalization after he was discharged from the ambulatory surgery center. Outpatient transurethral resection of the prostate can be performed safely with excellent patient satisfaction and cost-effectiveness. Alternative treatment modalities for benign prostatic hyperplasia should be evaluated against outpatient transurethral resection of the prostate before they are broadly embraced.
- Published
- 1994
- Full Text
- View/download PDF
27. Intravesical bacillus Calmette-Guerin for patients with high-risk superficial bladder cancer.
- Author
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Klimberg IW, Pow-Sang JM, Cartwright CK, and Wajsman Z
- Subjects
- Administration, Intravesical, Adult, Aged, Aged, 80 and over, BCG Vaccine adverse effects, Carcinoma, Transitional Cell pathology, Female, Follow-Up Studies, Humans, Male, Middle Aged, Neoplasm Recurrence, Local, Urinary Bladder Neoplasms pathology, BCG Vaccine administration & dosage, Carcinoma, Transitional Cell therapy, Urinary Bladder Neoplasms therapy
- Abstract
Intravesical bacillus Calmette-Guérin (BCG) was employed in the treatment of 55 patients with aggressive superficial transitional cell carcinoma of the bladder (cTa, cT1, cTis). All of the patients had a previous history of recurrent superficial disease, and 41 (75%) were treatment failures following other intravesical therapy. Thirty-six (66%) patients responded to treatment, and 19 (34%) were treatment failures. Twenty-seven (66%) of 41 patients with cTa-cT1 tumors and 9 (64%) of 14 patients with cTis responded, with a mean follow-up period of 30.5 months. Disease progression was noted in 8 (15%) of the patients and muscle invasive disease in 6. Patients with a history of three or more previous events of tumor recurrence, positive urinary cytology, and multicentric disease, all fared worse than patients without these characteristics (p less than 0.05). BCG is an effective agent in controlling superficial transitional cell carcinoma of the bladder, even in a high-risk group of patients who failed previous intravesical therapy. BCG should be employed in this group of patients prior to radical surgery.
- Published
- 1991
- Full Text
- View/download PDF
28. The prognostic value of the pT-category after combination chemotherapy for patients with invasive bladder cancer who underwent cystectomy. EORTC-GU group.
- Author
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Splinter TA, Scher HI, Denis L, Bukowski R, Soloway M, Vogelzang N, Klimberg I, Dalesio O, and Herr H
- Subjects
- Carcinoma, Transitional Cell mortality, Carcinoma, Transitional Cell pathology, Combined Modality Therapy, Follow-Up Studies, Humans, Neoplasm Invasiveness, Neoplasm Staging, Prognosis, Survival Rate, Urinary Bladder Neoplasms mortality, Urinary Bladder Neoplasms pathology, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carcinoma, Transitional Cell therapy, Cystectomy, Urinary Bladder Neoplasms therapy
- Published
- 1990
29. Staging evaluation and follow-up of patients with advanced prostatic cancer.
- Author
-
Wajsman Z and Klimberg IW
- Subjects
- Biomarkers, Tumor blood, Bone Neoplasms blood, Bone Neoplasms diagnostic imaging, Bone Neoplasms secondary, Carcinoma blood, Follow-Up Studies, Humans, Lymphatic Metastasis, Male, Neoplasm Staging, Pelvis, Prostatic Neoplasms blood, Radionuclide Imaging, Carcinoma pathology, Prostatic Neoplasms pathology
- Published
- 1988
30. Duplicated inferior vena cava simulating retroperitoneal lymphadenopathy in a patient with embryonal cell carcinoma of the testicle.
- Author
-
Klimberg I and Wajsman Z
- Subjects
- Adult, Diagnosis, Differential, Humans, Male, Tomography, X-Ray Computed, Vena Cava, Inferior diagnostic imaging, Lymphatic Diseases diagnostic imaging, Retroperitoneal Space diagnostic imaging, Teratoma diagnostic imaging, Testicular Neoplasms diagnostic imaging, Vena Cava, Inferior abnormalities
- Abstract
Computerized tomography has become the most widely applied staging technique in the assessment of retroperitoneal lymph nodes in patients with nonseminomatous testicular carcinoma. Errors in clinical staging of testicular carcinoma can have serious implications for the treatment afforded these patients. We describe a duplicated inferior vena cava that simulated retroperitoneal lymphadenopathy on abdominal computerized tomography in a patient with embryonal cell carcinoma of the testicle. The embryology and implications of anomalous lymphatic drainage of the testicle are discussed.
- Published
- 1986
- Full Text
- View/download PDF
31. Hemorrhage from congenital renal arteriovenous malformation in pregnancy.
- Author
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Klimberg I, Wilson J, Davis K, and Finlayson B
- Subjects
- Adult, Arteriovenous Malformations pathology, Arteriovenous Malformations surgery, Female, Hemorrhage pathology, Hemorrhage surgery, Humans, Kidney Pelvis pathology, Nephrectomy, Pregnancy, Pregnancy Complications, Cardiovascular pathology, Pregnancy Complications, Cardiovascular surgery, Radiography, Renal Artery diagnostic imaging, Renal Veins diagnostic imaging, Arteriovenous Malformations diagnostic imaging, Hemorrhage diagnostic imaging, Pregnancy Complications, Cardiovascular diagnostic imaging, Renal Artery abnormalities, Renal Veins abnormalities
- Abstract
A case report of life-threatening hemorrhage from a congenital renal arteriovenous malformation during pregnancy is presented. The hyperdynamic circulatory state that exists during pregnancy may predispose to bleeding from vascular malformations. We review the classification and clinical presentation of renal arteriovenous malformations.
- Published
- 1984
- Full Text
- View/download PDF
32. Oncocytoma in a horseshoe kidney.
- Author
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Klimberg I, Epstein H, and Wajsman Z
- Subjects
- Adenoma diagnostic imaging, Adenoma pathology, Humans, Kidney pathology, Kidney Neoplasms diagnostic imaging, Kidney Neoplasms pathology, Male, Middle Aged, Tomography, X-Ray Computed, Adenoma complications, Kidney abnormalities, Kidney Neoplasms complications
- Abstract
Renal oncocytoma is an unusual tumor that has been identified with increasing frequency during the last decade, and more than 150 cases have been reported in the literature, including multifocal and bilateral tumors. We report a case of oncocytoma in a horseshoe kidney. Oncocytoma and tumors in horseshoe kidneys are discussed.
- Published
- 1986
- Full Text
- View/download PDF
33. A comparison of the Mustardé and Horton-Devine flip-flap techniques of hypospadias repair.
- Author
-
Klimberg I and Walker RD
- Subjects
- Adolescent, Child, Child, Preschool, Follow-Up Studies, Humans, Infant, Male, Methods, Postoperative Complications etiology, Surgical Flaps, Time Factors, Urethral Diseases etiology, Urinary Fistula etiology, Hypospadias surgery
- Abstract
We compared the results and complications of the Horton-Devine flip-flap and Mustardé techniques for 1-stage repair of distal hypospadias. Followup has been for at least 1 year so that long-term complications could be included. Urethral fistulas occurred in 6 of 20 patients treated with the Horton-Devine flip-flap and 3 of 20 who underwent the Mustardé repair. No strictures were noted with either procedure. In our opinion the meatus had a better configuration after the Mustardé repair. We conclude that the Mustardé procedure provides a more satisfying cosmetic and clinical result.
- Published
- 1985
- Full Text
- View/download PDF
34. Absolute ethanol renal angioinfarction for control of hypertension.
- Author
-
Klimberg IW, Locke DR, Hawkins IF Jr, and Drylie DM
- Subjects
- Adult, Antihypertensive Agents therapeutic use, Child, Female, Humans, Male, Renal Artery, Embolization, Therapeutic, Ethanol therapeutic use, Hypertension, Renal therapy
- Abstract
Six patients (11 renal units) underwent ethanol renal angioinfarction for medically uncontrollable hypertension. The mean preablation blood pressure was 175/112 mm Hg despite antihypertensive medications. Five of the patients demonstrated elevated renal vein renin levels prior to angioinfarction. Hypertension was improved in all 6 patients, during a mean follow-up period of fifty-one months. Systemic hypertension was completely eliminated in 4 patients. Two patients continue to require antihypertensive medication to control their hypertension. There were no major complications directly related to intra-arterial injection of ethanol. Transcatheter renal ablation employing intra-arterial injection of absolute ethanol for control of severe hypertension appears to be a safe and efficacious procedure. It should be considered an alternative to nephrectomy in selected high-risk patients.
- Published
- 1989
- Full Text
- View/download PDF
35. Primary malignant melanoma of the male urethra.
- Author
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Pow-Sang JM, Klimberg IW, Hackett RL, and Wajsman Z
- Subjects
- Aged, Humans, Male, Middle Aged, Urethra pathology, Melanoma epidemiology, Melanoma pathology, Urethral Neoplasms epidemiology, Urethral Neoplasms pathology
- Abstract
Primary malignant melanoma of the male urethra is a rare disease, with only 24 cases previously reported in the literature, including 1 black patient. We describe 2 additional patients with primary malignant melanoma of the urethra, one of whom was a black man. The literature is reviewed briefly and treatment recommendations are discussed.
- Published
- 1988
- Full Text
- View/download PDF
36. Treatment alternatives for invasive bladder cancer.
- Author
-
Wajsman Z and Klimberg IW
- Subjects
- Carcinoma, Transitional Cell radiotherapy, Carcinoma, Transitional Cell surgery, Cisplatin administration & dosage, Combined Modality Therapy, Humans, Methotrexate administration & dosage, Urinary Bladder Neoplasms radiotherapy, Urinary Bladder Neoplasms surgery, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carcinoma, Transitional Cell drug therapy, Urinary Bladder Neoplasms drug therapy
- Abstract
Radical cystectomy remains the gold standard in the treatment of patients with muscle invasive bladder cancer. However, the specter of high failure rates coupled with morbid treatment methods has caused urologists, oncologists, and radiotherapists to explore modifications in, and alternatives to, the traditional treatments for invasive bladder cancer. The identification of the active methotrexate-platinum-based combination chemotherapy regimens heralds a new era in our ability to treat advanced disease effectively. Patients with less extensive muscle invasive tumors may be efficiaciously treated using conservative surgical excision, either alone or in combination with adjunctive treatments. In addition, definitive radiation therapy, given via the interstitial route or in combination with radiosensitizers, may result in long-term survival and preservation of bladder function. Progress has been made on multiple fronts in our ability to improve overall survival rates while allowing for the preservation of bladder function. The ability of these new mixed multimodality treatment initiatives to produce viable statistics equal to that of radical exenteration is an important landmark on the route towards an ideal treatment for invasive bladder cancer.
- Published
- 1989
- Full Text
- View/download PDF
37. Spontaneous regression of testicular seminoma: case report.
- Author
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Holmes AS, Klimberg IW, Stonesifer KJ, Kramer BS, and Wajsman Z
- Subjects
- Adult, Humans, Lymphatic Metastasis, Male, Dysgerminoma pathology, Neoplasm Regression, Spontaneous, Testicular Neoplasms pathology, Testis pathology
- Abstract
A 33-year-old man had a 1-year history of a painless testicular mass and a 2-month history of an enlarging left supraclavicular mass. Biopsy of the supraclavicular mass showed classical seminoma. Massive abdominal lymphadenopathy was demonstrated by computerized tomography. Radical orchiectomy was performed and examination of the specimen showed only fibrous scar tissue consistent with regression of a primary tumor in the testis. While complete regression of a primary testicular tumor with progressive growth of metastases is well recognized in cases of nonseminomatous germ cell tumors, this phenomenon is reported rarely with seminoma.
- Published
- 1986
- Full Text
- View/download PDF
38. Percutaneous placement of suprapubic cystostomy tube.
- Author
-
Klimberg I and Wehle M
- Subjects
- Humans, Punctures methods, Urinary Catheterization instrumentation, Urinary Bladder surgery, Urinary Catheterization methods
- Published
- 1985
- Full Text
- View/download PDF
39. Preoperative angioinfarction of localized renal cell carcinoma using absolute ethanol.
- Author
-
Klimberg I, Hunter P, Hawkins IF, Drylie DM, and Wajsman Z
- Subjects
- Adult, Aged, Carcinoma, Renal Cell surgery, Female, Humans, Kidney Neoplasms surgery, Male, Middle Aged, Nephrectomy, Preoperative Care, Carcinoma, Renal Cell therapy, Embolization, Therapeutic, Ethanol therapeutic use, Kidney Neoplasms therapy
- Abstract
A total of 25 patients with renal cell carcinoma underwent angioinfarction of the tumor using absolute ethanol. An average of 15 ml. absolute ethanol was injected into the main renal artery through a balloon occlusion catheter. Complete cessation of renal arterial flow could be demonstrated in all cases. The post-embolization syndrome of pain, nausea, vomiting, hypertension and fever was minimal compared to other methods of renal artery occlusion. Of the patients 21 underwent post-infarction transabdominal radical nephrectomy without intraoperative or postoperative complications attributable to the injection of absolute ethanol. No damage to extrarenal tissue was noted at operation. Subsequent surgical dissection was facilitated, particularly in cases of large tumors when control of the renal pedicle often is difficult. Median blood loss was 725 ml. In light of recent reports concerning the benefit of angioinfarction and nephrectomy in metastatic disease a similar approach may be applicable to localized disease. This pilot study shows the safety of preoperative angioinfarction with absolute ethanol and may be used as a reference for future randomized prospective studies comparing angioinfarction and nephrectomy to nephrectomy alone for localized renal cell carcinoma.
- Published
- 1985
- Full Text
- View/download PDF
40. Autotransfusion and blood conservation in urologic oncology.
- Author
-
Klimberg IW
- Subjects
- Blood Transfusion, Autologous instrumentation, Humans, Intraoperative Period, Blood Transfusion, Autologous methods, Hemodilution methods, Urologic Neoplasms surgery
- Abstract
Autotransfusion is the reinfusion of the patient's own blood. Currently utilized forms include preoperative donation, perioperative hemodilution, and intraoperative salvage. The principal benefit of autotransfusion is a reduction in the complications associated with receipt of homologous blood products. Principal among these are febrile reactions, allergic and hemolytic reactions, alloimmunization, and the transmission of hepatitis and acquired immune deficiency syndrome. An additional benefit in the management of cancer patients is the avoidance of transfusion induced immunosuppression. Predeposit autologous transfusion is a simple and safe method to reduce patient's requirements for exogenous blood. Although well suited for cancer patients, predeposit programs remain underutilized with only 5% participation. Perioperative hemodilution can be a valuable adjunct in selected patients. Although the presence of malignancy has been regarded as a contraindication to the use of intraoperative autotransfusion, preliminary reports suggest that intraoperative autotransfusion can be safely used in patients undergoing surgery for urologic malignancies.
- Published
- 1989
- Full Text
- View/download PDF
41. Intraoperative autotransfusion in radical cystectomy for carcinoma of the bladder.
- Author
-
Hart OJ 3rd, Klimberg IW, Wajsman Z, and Baker J
- Subjects
- Adult, Aged, Carcinoma, Transitional Cell secondary, Female, Humans, Intraoperative Period, Male, Middle Aged, Blood Transfusion, Autologous adverse effects, Carcinoma, Transitional Cell surgery, Urinary Bladder surgery, Urinary Bladder Neoplasms surgery
- Abstract
From 1984 to 1987, 49 patients with transitional cell carcinoma of the bladder underwent radical cystectomy during which intraoperative autotransfusion was used. Thirty-three patients were observed for a minimum of one year postoperatively; the mean and median follow-up periods in this group were 23.8 and 26.0 months. Twenty-nine of these 33 patients were alive at the time of reporting; 25 were alive with no evidence of disease, and seven had postoperative recurrence of disease, and seven had postoperative recurrence of tumor. Diffused metastatic disease compatible with intravascular dissemination of tumor during autotransfusion did not develop in any of the patients. Intraoperative loss of blood ranged from 400 to 4,000 milliliters; the mean was 1,497, and the median, 1,300 milliliters. The mean volume of autotransfused blood was 492 milliliters. Autotransfusion accounted for 40 per cent of the total transfusion requirements of the patients and proved to be cost effective for the entire study group. Fear of dissemination of tumor has limited the use of intraoperative autotransfusion during surgical procedures for carcinoma. Analysis of our data failed to define any evidence for dissemination of tumor caused by autotransfusion in patients who underwent radical cystectomy.
- Published
- 1989
42. Persistent acid-fast bacilli following intravesical bacillus Calmette-Guerin.
- Author
-
Linn R, Klimberg IW, and Wajsman Z
- Subjects
- Administration, Intravesical, Aged, BCG Vaccine therapeutic use, Humans, Male, Risk Factors, Time Factors, BCG Vaccine adverse effects, Carcinoma, Transitional Cell therapy, Epididymitis etiology, Granuloma etiology, Prostatitis etiology, Urinary Bladder Diseases etiology, Urinary Bladder Neoplasms therapy
- Abstract
Intravesical bacillus Calmette-Guerin immunotherapy has great efficacy in the treatment of superficial transitional cell carcinoma of the bladder. We report a case of persistent acid-fast bacilli contained within granulomas of the bladder, prostate and epididymides 1 year after treatment with intravesical bacillus Calmette-Guerin. Although commonly encountered immediately after therapy, there are no reported cases of persistent acid-fast bacilli following intravesical administration of bacillus Calmette-Guerin.
- Published
- 1989
- Full Text
- View/download PDF
43. Treatment for muscle invasive carcinoma of the bladder.
- Author
-
Klimberg IW and Wajsman Z
- Subjects
- Combined Modality Therapy, Humans, Urinary Bladder Neoplasms mortality, Urinary Bladder Neoplasms therapy
- Published
- 1986
- Full Text
- View/download PDF
44. Needle aspiration and needle biopsy procedures.
- Author
-
Wajsman Z and Klimberg I
- Subjects
- Humans, Male, Pelvic Neoplasms pathology, Penile Neoplasms pathology, Prostatic Neoplasms pathology, Urinary Bladder Neoplasms pathology, Urologic Diseases pathology, Ambulatory Care, Biopsy, Needle, Lymph Nodes pathology, Prostate pathology
- Abstract
Needle biopsy of the prostate, employing large "core" needles and performed via the transperineal or transrectal routes, is a well-established method for diagnosing prostatic malignancy. This procedure can be performed safely under local anesthesia in an outpatient setting. Rectal cleansing and prophylactic antibiotics have minimized infectious complications following transrectal biopsy, and it remains the favored technique in patients with small lesions. Repeat biopsy under anesthesia is indicated when the clinical suspicion of malignancy remains high despite negative biopsies. In contrast to "core" needle biopsy, which obtains a cylinder of tissue for histologic examination, the fine-needle biopsy obtains a specimen for cytologic examination. If cytologic expertise is unavailable locally, the specimen may be fixed in the office and shipped to a major medical center for interpretation. Fine-needle aspiration may be safely employed to biopsy the prostate, pelvic masses, and inguinal and pelvic lymph nodes. Biopsy of palpable masses can be done simply and safely with morbidity akin to venipuncture. Nonpalpable tissues may be biopsied under radiographic guidance. Fine-needle aspiration biopsy is safe and cost-effective, has resulted in a significant improvement in the accuracy of our clinical staging, and has spared many patients unnecessary surgical procedures.
- Published
- 1987
45. Renal cell carcinoma and idiopathic thrombocytopenic purpura.
- Author
-
Klimberg I and Drylie DM
- Subjects
- Adenocarcinoma diagnosis, Aged, Humans, Kidney Neoplasms diagnosis, Male, Purpura, Thrombocytopenic diagnosis, Adenocarcinoma complications, Kidney Neoplasms complications, Purpura, Thrombocytopenic complications
- Abstract
A syndrome resembling idiopathic thrombocytopenic purpura has been described previously to occur in association with diverse forms of cancer. Herein we present the first reported case of renal cell carcinoma associated with idiopathic thrombocytopenic purpura, a review of the literature, and the pathophysiology of platelet destruction.
- Published
- 1984
- Full Text
- View/download PDF
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