Hypersensitivity reaction associated with intravesical bacillus Calmette-Guerin for interstitial cystitis.
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Biomedical subjects
Publications and source records attributed to J Curtis Nickel.
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PURPOSE: We determined the effect of a best evidence based monotherapeutic strategy for patients diagnosed with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) referred to a specialized prostatitis clinic. MATERIALS AND METHODS: Patients with CP/CPPS referred by urologists after failure of prescribed therapy for evaluation and treatment at Queen's University prostatitis research clinic were extensively evaluated, aggressively treated following a standardized treatment algorithm and followed for 1 year using a validated prostatitis specific symptom and quality of life instrument, the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI). All patients underwent a standardized protocol for CP/CPPS including a history, physical examination, standard 4-glass test, plus urethral swab and semen for microscopy and culture, uroflowmetry and residual urine determination. Treatment followed a best evidence based strategy with a standardized monotherapy based algorithm. RESULTS: A total of 100 consecutive patients with CP/CPPS (average age 42.2 years, range 20 to 70 and average symptom duration 6.5 years, range 0.5 to 39) had 1-year followup after initial evaluation. Patients were prescribed treatment based on documentation of "failed," "successful" and "never tried" therapies based on a standardized treatment algorithm. Patients treated successfully were continued on the prescribed therapy, while therapy was discontinued and new therapy instituted (based on algorithm) in those in whom the initially prescribed therapy failed. At 1 year there was a statistically significant decrease in total NIH-CPSI (23.3 to 19.5, p = 0.0004), pain (11.0 to 9.4, p = 0.03) and quality of life (7.7 to 6.1, p <0.001), but not voiding (4.6 to 4.0, p = 0.12). A perceptible 25% decrease in total NIH-CPSI symptom score was noted in 37% and the greatest improvement was in the quality of life domain (43% of patients had greater than 25% improvement in quality of life). Of the patients 35% had a significant decrease of greater than 6 points in total NIH-CPSI. A clear, clinically significant improvement in total NIH-CPSI (greater than 50% decrease) was noted in 19%. CONCLUSIONS: Approximately a third of patients with treatment refractory CP/CPPS undergoing extensive evaluation and therapy based on a sequential monotherapy treatment strategy in a specialized prostatitis clinic had at least modest improvement in symptoms during 1 year. This study confirms that a treatment strategy based on the sequential application of monotherapies for patients with a long history of severe CP/CPPS remains relatively poor.
PURPOSE: Chronic Pelvic Pain Syndrome (CPPS) is a common debilitating condition in which ejaculation relieves symptoms for some but exacerbates them in others. We studied ejaculatory pain in a cohort with CPPS to investigate associations with symptoms, quality of life and risk factors. MATERIALS AND METHODS: The 486 men in the National Institutes of Health Chronic Prostatitis Cohort study were stratified into 4 subgroups according to the presence of ejaculatory pain at baseline visit and at each of 3 monthly followup contacts. Subgroups were based on answers and labeled NO (always "no"), Nvar ("no" at baseline but "yes" or missing at least once), Yvar ("yes" at baseline but "no" or missing at least once) and YES (always "yes"). Demographic and quality of life data were obtained at baseline, together with medical and sexual history, symptoms, and cultures and microscopy of urine and seminal fluids. Associations among selected baseline risk factors, symptoms and post-ejaculatory pain were analyzed. RESULTS: Overall 128 men were classified as NO, 106 as Nvar, 137 as Yvar and 115 as YES. There was a progressive increase in baseline National Institutes of Health-Chronic Prostatitis Symptom Index total score (modified to exclude post-ejaculatory pain) from 18.5 for the NO subgroup to 25.5 for the YES subgroup (p <0.0001). Mental and physical quality of life were also progressively lower from the NO to the YES subgroup (p <0.001). There were no significant differences in white blood cell count or bacterial growth in urine, prostate fluid or semen among subgroups. Men in the YES subgroup were younger, more likely to live alone, had lower income and a greater variety of sexual practices than those without ejaculatory pain (NO subgroup). CONCLUSIONS: Patients with CPPS and persistent ejaculatory pain have more severe symptoms, are less likely to improve with time, and have differences in demographic and sexual history compared to other patients with CPPS.
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OBJECTIVES: To examine the cross-sectional relationship of age, urinary and depressive symptoms and partner status on pain intensity and quality of life (QoL) in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). PATIENTS AND METHODS: In all, 463 men enrolled in the National Institutes of Health (NIH) Chronic Prostatitis Cohort Study from seven clinical centres (six in the USA and one in Canada) reported baseline screening symptoms using the NIH Chronic Prostatitis Symptom Index (CPSI). The CPSI provides scores for pain, urinary symptoms and QoL. In addition, a demographic profile, including age and partner (living with another) status, and a depressive symptom score were obtained. Regression modelling of QoL, adjusting for between-centre variability, examined the unique effects of age, partner status, urological symptoms, depressive symptoms and pain. RESULTS: Urinary scores, depressive symptoms and pain intensity scores significantly predicted QoL for patients with CP/CPPS (higher CPSI QoL scores indicated more impairment; median 8.0, range 0-12). On average, for every 1-point increase in urinary scores, there was a corresponding increase in QoL score of 0.118 points (P = 0.001); for every 1-point increase in pain intensity score, there was a corresponding increase in QoL score of 0.722 points (P < 0.001); and for every 1-point decrease in depressive symptoms (lower scores equal poorer mood), the QoL score increased (poorer quality of life) by 0.381 points (P < 0.001). Age and partner status did not significantly contribute to poorer QoL. Urinary scores and depressive symptoms were significant predictors (P < 0.001) of pain in patients with CP/CPPS. CONCLUSIONS: These data show that depressive symptoms and pain intensity significantly predict a poorer QoL in patients with CP/CPPS, and that these effects are independent of partner status, age and urinary status. In particular, pain intensity was the most robust predictor of a poorer QoL. Further data relating pain and psychological factors to CP/CPPS are highly recommended, to aid in determining specific factors for pain and its impact on QoL. These data are essential if empirically guided efforts to manage pain are to progress.
The 2003 American Urological Association (AUA) guideline on management of benign prostatic hyperplasia (BPH) was released at the AUA annual meeting in Chicago, April 2003 and the diagnosis and treatment recommendations were published later in 2003. It is likely that the 2003 AUA guideline on the management of BPH will have a profound effect on clinical urologic practice in the USA, but its influence on Canadian urological practice will be different because of our socialized medical system, manpower issues, availability of expensive technology and our unique Canadian perspective. The authors review the 2003 AUA guideline on the management of BPH and based on a perspective obtained from recent publications, consensus/consultant meetings, focus groups and anecdotal experience, attempt to put the recommendations into Canadian context. We conclude that the 2003 AUA guideline for the management of BPH is an important document that should be studied, evaluated and understood by Canadian urologists. Although our perspective is clearly different than our US colleagues, it is likely that the guideline will influence the management of BPH in Canada.
OBJECTIVE: The Proscar Long-Term Efficacy and Safety Study (PLESS) and the Medical Therapy of Prostatic Symptoms (MTOPS) study provide new evidence regarding the benefits of finasteride in the treatment of benign prostatic hyperplasia (BPH). The objective of this study was to utilize data from the PLESS and MTOPS studies to assess the cost-utility of finasteride and finasteride in combination with doxazosin, compared to doxazosin alone in men with moderate to severe BPH symptoms. METHODS: A semi-Markov decision analytic model was constructed to estimate the clinical consequences, costs and cost-utility of doxazosin, finasteride, and combination therapy. Analyses were conducted for a 15-year time frame from the perspective of the Ontario Ministry of Health and Long Term Care (MOHLTC). Results are reported stratified by baseline serum prostate-specific antigen (PSA) level according to all baseline serum PSA levels, patients with baseline serum PSA > 1.3 ng/ml, and patients with baseline serum PSA > 3.2 ng/ml. RESULTS: Compared to doxazosin alone, combination therapy was more expensive but more effective. Cost-utility ratios ranged from 27,823 dollars/QALY for patients with PSA > 3.2 ng/ml to 34,085 dollars/QALY for all patients. Finasteride, although dominated by doxazosin, may be cost-effective compared to watchful waiting in patients who fail doxazosin and do not choose to proceed to surgery. Compared to watchful waiting, cost-utility ratios for finasteride ranged from 35016 dollars/QALY for patients with PSA > 3.2 ng/ml to 44,336 dollars/QALY for all patients. Results were robust across a wide range of sensitivity analyses. CONCLUSIONS: Combination therapy is cost-effective compared to doxazosin with cost-utility ratios under 40,000 dollars/QALY across a wide range of scenarios. The cost-effectiveness of combination therapy increases as serum PSA level increases.
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Finasteride selectively inhibits the Type 2 isoenzyme of 5alpha-reductase (5AR) (the enzyme responsible for converting testosterone to dihydrotestosterone [DHT]) whereas dutasteride inhibits both Type 1 and Type 2 5AR. General conclusions regarding the differences and similarities of these 2 agents, in terms of pharmacologic effect, safety, and efficacy, can be drawn from evaluation of short-term comparative trials and similar but non-comparative long-term trials. Dutasteride therapy reduces serum DHT significantly more than does finasteride. In men with benign prostatic hyperplasia (BPH), treatment with either agent results in similar prostate gland volume reduction, flow rate and symptom improvement, and similar reductions in long-term risk of BPH development in terms of symptom progression and acute urinary retention (AUR) and BPH-related surgery. There does not appear to be any clinically significant difference between the adverse event profiles of dutasteride and finasteride. Although weak evidence suggests a difference in the onset of clinical benefit, the available non-comparative trial data do not confirm this finding. Patients with symptomatic BPH who receive dutasteride or finasteride, either as monotherapy or combination therapy with alpha-blockers, can expect to experience significant prostate gland size reduction, improved symptoms, and reduced risk of progression in terms of long-term adverse outcomes.
Prostatitis is a prevalent, confusing and frustrating clinical presentation for urologists. Three recent international and North American consensus meetings have drafted suggestions for the evaluation of a man presenting with prostatitis. Published consensus statements from the 2000 Washington meeting of the International Prostatitis Collaborative Network, the 2002 Virginia meeting of the National Institutes of Health Chronic Prostatitis Collaborative Research Network and the 2002 Giessen meeting of the International Consensus Conference on Advances in the Diagnosis and Treatment of Prostatitis were examined to develop suggestions for evaluation of the prostatitis patient by urologists. Clinical, laboratory and imaging evaluations for the patient presenting with prostatitis and chronic prostatitis/chronic pelvic pain syndrome can be categorized as basic or mandatory evaluations (which would include a complete history, focused physical examination, and urinalysis/urine culture), further or recommended evaluations (those that are recommended but not mandatory) and optional evaluations in selected patients. As more evidence and data are accumulated and published, these recommendations may eventually evolve into practice guidelines for the evaluation of men presenting with prostatitis symptoms.
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OBJECTIVES: To determine in a pilot study whether acupuncture improved pain, voiding symptoms, and the quality of life of men with chronic prostatitis/chronic pelvic pain syndrome. METHODS: Men diagnosed with chronic prostatitis/chronic pelvic pain syndrome (National Institutes of Health [NIH] criteria) who were refractory to standard therapy (antibiotics, alpha-blockers, anti-inflammatories, phytotherapy) were referred for acupuncture therapy. The treatment protocol involved three sets of acupuncture points totaling 30 points (8 points were electrically stimulated) given alternatively twice weekly for 6 weeks. The patients completed the NIH Chronic Prostatitis Symptom Index (CPSI) at baseline and the CPSI and subjective global assessment at 6 weeks (end of treatment), 12 weeks, and at least 6 months after the baseline assessment. RESULTS: Twelve men underwent a minimum of 6 weeks of acupuncture treatment. The average follow-up (from baseline) was 33 weeks (range 24 to 52). A significant decrease occurred in total NIH-CPSI (28.2 to 8.5), NIH-CPSI pain (14.1 to 4.8), NIH-CPSI urinary (5.2 to 1.3), and NIH-CPSI quality-of-life (8.8 to 2.3) scores after an average of 33 weeks of follow-up. Ten patients (83%) had a sustained greater than 50% decrease in NIH-CPSI at final visit (average 33 weeks). Ten patients (83%) reported marked improvement on the subjective global assessment at 12 weeks. At an average of 33 weeks, 8 patients (67%) had sustained marked improvement on subjective global assessment evaluation. No adverse events were reported in this pilot study. CONCLUSIONS: Acupuncture appears to be a safe, effective, and durable treatment in improving symptoms in, and the quality of life of, men with chronic prostatitis/chronic pelvic pain syndrome refractory to treatment. A larger controlled study is required to confirm these encouraging initial results.
OBJECTIVES: To perform a prospective, placebo-controlled study to examine the long-term efficacy of alfuzosin compared with placebo and standard therapy in patients with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), because alpha-blockers have been suggested for the treatment of CP/CPPS. METHODS: One hundred twenty consecutive men diagnosed with CP/CPPS were prospectively screened and then asked to participate in a prostatitis treatment trial. Patients who agreed to be randomized were subsequently randomized to alfuzosin 5 mg twice daily or placebo and patients who agreed to participate but not be randomized were entered into a control or standard (except alpha-blockers) therapy group. Patients were prospectively treated for 6 months and then followed up for an additional 6 months. The change from baseline in the total and domain scores of the validated Finnish version of the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) was the primary outcome parameter for this study. RESULTS: Seventy subjects agreed to participate in the study. The data from 66 patients were available for evaluation (17 in the alfuzosin, 20 in the placebo, and 29 in the control/standard group). At the end of 6 months of active therapy, the alfuzosin group had had a statistically significant decrease in total NIH-CPSI score compared with the placebo and control/standard groups (9.9, 3.8, and 4.3 decrease, respectively, P = 0.01). A statistically significant improvement occurred in the pain score in the alfuzosin group at 6 months compared with the placebo and control/standard groups (P = 0.01), but not in the voiding or quality-of-life score among the three groups. Of the patients in the alfuzosin group, 65% had a greater than 33% improvement in the mean NIH-CPSI total score compared with 24% and 32% of the placebo and control/standard groups, respectively (P = 0.02). At 12 months (6 months after the alfuzosin/placebo treatment was discontinued), the symptom scores in all domains of the NIH-CPSI showed deterioration compared with original baseline score in the alfuzosin and placebo groups but not in the control/standard group (NIH-CPSI score 3.5, 0.1, and 5.6 points below baseline, respectively). Gastrointestinal symptoms and a decrease in ejaculate volume were noted by 1 and 4 patients, respectively, in the alfuzosin group. No patients dropped out of the study because of an adverse event. CONCLUSIONS: Six months of alfuzosin therapy for CP/CPPS is safe and well tolerated and results in a modest, but statistically significant, improvement in the NIH-CPSI, particularly in the pain domain, compared with placebo and standard/traditional treatment. The beneficial effect is only apparent after several months of treatment and disappears when treatment is discontinued.
The first empirical use of alpha(1)-adrenoceptor antagonists in urology occurred about 25 years ago in patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH), or LUTS/BPH. Today, many randomized, controlled trials have provided evidence for the efficacy and tolerability of alpha(1)-adrenoceptor antagonists in LUTS/BPH, and they are the most frequently used initial treatment option for this cause of LUTS. For many years, alpha(1)-adrenoceptor antagonists have also been used empirically in other types of lower urinary tract dysfunction (LUTD), such as chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) and neurogenic LUTD (NLUTD). Several investigators have shown that alpha(1)-adrenoceptor antagonists may be useful in patients with CP/CPPS. This was recently confirmed by a 6-week, double-blind, placebo-controlled pilot study evaluating the efficacy and safety of tamsulosin in 58 CP/CPPS patients. Further well-designed and -powered research into the use of alpha(1)-adrenoceptor antagonists in patients with CP/CPPS is currently ongoing. Several small-scale predominantly open-label studies have suggested that alpha(1)-adrenoceptor antagonists may be of benefit in patients with NLUTD. Data from 2 recent large-scale studies with tamsulosin in patients with NLUTD caused by suprasacral spinal cord injury suggest that long-term tamsulosin treatment improves bladder storage and emptying and also reduces symptoms of autonomic dysreflexia. Tamsulosin has also shown promise in ameliorating (early) storage symptoms and urinary retention associated with transurethral microwave thermotherapy, external-beam radiotherapy, and brachytherapy. In BPH patients presenting with the ultimate form of LUTS-acute urinary retention-treatment with tamsulosin before catheter removal results in a higher success rate of catheter-free voiding. Finally, it seems that alpha(1)-adrenoceptor antagonists may reduce the occurrence of urinary retention after (general) surgery. We can therefore conclude that alpha(1)-adrenoceptor antagonists, such as tamsulosin, may be useful for treating men with LUTS beyond BPH.
OBJECTIVES: To perform a Canadian multicenter randomized placebo-controlled trial to evaluate the safety and efficacy of 6 weeks of levofloxacin therapy compared with placebo in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Uncontrolled studies have supported the use of antibiotics in CP/CPPS. METHODS: Men with a National Institutes of Health (NIH) diagnosis of CP/CPPS (specifically, no infection localized to the prostate) were randomized to levofloxacin (500 mg/day) or placebo for 6 weeks in 11 Canadian centers. Patients were assessed at baseline and at 3, 6, and 12 weeks with the NIH Chronic Prostatitis Symptom Index (NIH-CPSI) and global patient assessments (subjective global assessment and patient assessment questionnaire). RESULTS: Eighty men (average age 56.0 years, range 36 to 78; duration of symptoms 6.5 years, range 0.6 to 32) were randomized to receive levofloxacin (n = 45) or placebo (n = 35). All were evaluated in an intent-to-treat analysis. Both groups experienced progressive improvement in symptoms as measured by the NIH-CPSI. However, the difference in response was not statistically or clinically significant at end of treatment (6 weeks) or at the end of the follow-up visits (12 weeks). No patients withdrew because of adverse events. One patient withdrew before the 6-week assessment. Adverse events (all mild) were reported in 20% of the levofloxacin group and 17% of the placebo group. CONCLUSIONS: This pilot placebo-controlled study showed that 6 weeks of levofloxacin therapy in men diagnosed with CP/CPPS resulted in symptom improvement that was not significantly different from that with placebo at end of treatment or follow-up. The clinical ramifications of these findings need to be addressed.
PURPOSE: Topical steroids have been advocated as an effective economical alternative to circumcision in boys with phimosis. We evaluated the effectiveness of topical steroid therapy as primary treatment in 194 patients with phimosis. METHODS: Between January 1996 and November 2000, 228 boys 16 years old or younger were referred for consideration of circumcision. When intervention was determined to be necessary, a 6-week course of topical steroids was used as primary treatment. Efficacy of treatment was evaluated at 3 months from initiation of therapy. RESULTS: Of the 228 patients 15 had such a mild degree of phimosis that no intervention was believed to be necessary, 19 were scheduled directly for circumcision due to cosmetic reasons, parent wishes, or severe phimosis with associated voiding problems and the remaining 194 received topical steroids as primary treatment. Of these 194 patients 25 had coexisting balanitis and 4 had a history of urinary tract infection. Conservative treatment was successful in 87%, 88% and 75% of patients with phimosis alone, coexisting balanitis and history of urinary tract infection, respectively. Overall, circumcision was avoided in 87% of patients treated with topical steroids. CONCLUSION: Topical steroids are becoming the standard conservative measure for treating phimosis. Our study supports this trend, with an overall efficacy of 87%.
PURPOSE: We determine the effects of treatment with rofecoxib and placebo in patients with chronic prostatitis. MATERIALS AND METHODS: Patients diagnosed with chronic nonbacterial prostatitis were randomized to 6 weeks of 25 or 50 mg., rofecoxib or placebo in a double-blind multicenter study with a 1-week run in of placebo. End points included the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) (average pain score item 4 primary end point), and patient global assessment questions of pain, disease activity and response to therapy. RESULTS: A total of 161 patients were randomized in the study. The NIH-CPSI total, domain and pain scores significantly decreased from baseline in all groups and, although the mean scores numerically favored the rofecoxib groups, the difference was not significantly different among groups. There was a trend for the percentage of patients with a 25% (or 6 point) improvement in total score being superior on rofecoxib versus placebo with the difference being significantly different (p <0.05) for the 50 mg. rofecoxib group. Patient global assessment of pain, response to therapy and disease activity also favored rofecoxib over placebo (p <0.05, p = 0.07, p = 0.06, respectively). Of the patients 79% on 50 mg. rofecoxib versus 59% on placebo reported no or mild pain, and 56% of patients on 50 mg. rofecoxib versus 27% on placebo experienced significant improvement in quality of life (p <0.005). Rofecoxib was generally well tolerated. CONCLUSIONS: To our knowledge this study is the first to evaluate rofecoxib versus placebo in patients with prostatitis and the first large multicenter treatment study to use the NIH-CPSI. Subjective assessment with patient global questions may be more sensitive to change than the NIH-CPSI and, therefore, may be a better tool to use in future therapeutic trials. Although 6 weeks of rofecoxib treatment appear to benefit many men diagnosed with chronic prostatitis/chronic pelvic pain syndrome further studies are needed.