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Biomedical subjects

J Curtis Nickel

Publications and source records attributed to J Curtis Nickel.

At least 37 records · Page 2Linked to original sources
PubMed2005

A randomized controlled trial of intravesical bacillus calmette-guerin for treatment refractory interstitial cystitis.

PURPOSE: We compared intravesical bacillus Calmette-Guerin (BCG) to placebo instillations in patients with treatment refractory interstitial cystitis (IC). MATERIALS AND METHODS: Subjects who met the National Institutes of Health-National Institute for Diabetes and Digestive and Kidney Diseases criteria for IC, and reported at least moderate pain and frequency for a minimum of 6 months before study entry, were randomized to 6 weekly double-blinded intravesical instillations of either BCG or placebo, and then followed for a total of 34 weeks. The primary outcome was a patient reported global response assessment at week 34, supplemented with medications for IC during weeks 31 to 34. Secondary outcomes included a 24-hour voiding diary, pain, urgency, validated IC symptom indexes and adverse events. The target sample size was 260 participants, designed to detect a difference in response rates between placebo and BCG of 30% and 50%, respectively. RESULTS: A total of 265 participants were randomized and 17 (6%) patients withdrew from study. The response rates for the primary outcome were 12% for placebo and 21% for BCG (p = 0.062). Small improvements were observed for all secondary outcomes, some more so with BCG, but these differences were of borderline statistical significance. Although a large number of adverse events were reported in the BCG arm, there was no statistically significant difference between the treatment arms in overall adverse event rates. CONCLUSIONS: Although the BCG safety profile was acceptable, the response rate for the primary outcome was low. Effective medical treatment for patients with moderate to severe interstitial cystitis remains elusive.

Administration, Intravesical↗
PubMed2005

Pentosan polysulfate sodium therapy for men with chronic pelvic pain syndrome: a multicenter, randomized, placebo controlled study.

PURPOSE: We evaluated the efficacy and tolerability of pentosan polysulfate sodium (PPS) for the treatment of men with chronic pelvic pain syndrome (CPPS), National Institutes of Health (NIH) category III. MATERIALS AND METHODS: In a 16-week double-blind study 100 men with a clinical diagnosis of CPPS were randomized to receive 300 mg PPS or placebo 3 times daily. Clinical Global Improvement (CGI) was the primary outcome measure. Additional outcome measures were the NIH-Chronic Prostatitis Symptom Index (CPSI), Subjective Global Assessment and Symptom Severity Index assessment tools. RESULTS: Significantly more patients receiving PPS experienced moderate to marked improvement based on CGI assessment (18 or 37% vs 8 or 18%, p = 0.04). However, mean CGI scores were not significantly different between the PPS group (1.0) and placebo groups (1.0 vs 0.6, p = 0.107). All NIH-CPSI domains suggested a positive effect for PPS and for total NIH-CPSI the difference approached statistical significance (-5.9 or 22% vs -3.2 or 12%, p = 0.068). The PPS group showed significantly greater improvement in NIH-CPSI quality of life domain scores than the placebo group (-2.0 or 22% vs -1.0 or 12%, p = 0.031). Of patients receiving PPS 67% and 80% of those receiving placebo completed the 16-week study. Diarrhea, nausea and headache were the most common adverse events. CONCLUSIONS: Pentosan polysulfate (900 mg daily) was more likely than placebo to provide relief for CPPS symptoms.

Adolescent↗
PubMed2005

Benign prostatic hyperplasia (BPH) and prostatitis: prevalence of painful ejaculation in men with clinical BPH.

OBJECTIVES: To determine the prevalence and importance of pain/discomfort on ejaculation (prostatitis-like symptom) in men with lower urinary tract symptoms (LUTS) diagnosed with clinical benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: Baseline data from 5096 men reporting LUTS suggestive of BPH, and enrolled in the ALF-ONE study by general practitioners and urologists in Europe, Asia, Latin America, the Middle East and Canada, were analysed to determine the prevalence and significance of pain/discomfort on ejaculation. All the men were asked to complete the International Prostate Symptom Score (IPSS) questionnaire, the bother score (IPSS question 8), and the Danish Prostate Symptom Score sexual-function questionnaire (DAN-PSSsex) which assesses three symptoms (rigidity of erection, amount of ejaculate and pain/discomfort on ejaculation) and their bothersomeness. RESULTS: There were 3700 sexually active men who had an evaluable answer to the DAN-PSSsex question related to pain/discomfort on ejaculation. Of these, 688 (18.6%) reported pain/discomfort on ejaculation and 609 (88%) considered it was a problem. Patients with painful ejaculation had more severe LUTS and reported greater bother (P < 0.001). Of men with painful ejaculation, 72% reported erectile dysfunction, of whom 91% considered it a problem, and 75% reported reduced ejaculation, of whom 81% considered it a problem. By contrast, of men with no ejaculatory discomfort, 57% reported erectile dysfunction, of whom 79% considered it a problem, and 56% reported reduced ejaculation, of whom 57% considered it a problem. A history of urinary tract infection was reported by 12% of men in the ejaculatory pain group, compared with 7% in the LUTS-only group, while 5% of men in the ejaculatory pain group reported macroscopic haematuria, compared to 3% in the LUTS-only group. Men with ejaculatory pain were slightly younger, but there were no significant differences in duration of LUTS, history of acute urinary retention, prostate-specific antigen concentrations or maximum urinary flow rate compared to the LUTS-only group. CONCLUSIONS: Of sexually active men with LUTS suggestive of BPH, approximately 20% complain of specific prostatitis-like symptoms of pain/discomfort on ejaculation, and these men clearly differ from those who present with LUTS only. For most the symptom is a significant bother. Men with BPH and painful ejaculation have more severe LUTS and reported greater bother, and had a higher prevalence of erectile dysfunction and reduced ejaculation, than men with LUTS only. Evaluation and treatment strategies should address this population of men with symptoms suggestive of both prostatitis and BPH.

Aged↗
PubMed2005

Canadian guidelines for the management of benign prostatic hyperplasia.

OBJECTIVE: To develop the first Canadian guidelines for the management of lower urinary tract symptoms in men with benign prostatic hyperplasia (BPH). METHODS: These guidelines, developed under a mandate provided by the Canadian Urological Association (CUA), were a collaborative effort between the CUA guidelines committee and the Canadian Prostate Health Council. BPH guidelines developed by the American Urological Association, the European Association of Urology, the World Health Organization International Consultation on BPH, and similar committees from Germany, Sweden and Australia were reviewed. The committee further reviewed a systematic literature search, updated to May 2004, and systematically derived Canadian urological opinion data. RESULTS: The subsequent Canadian BPH guidelines were developed as an evidence based consensus among the committee members. Mandatory evaluation includes history, physical examination and urinalysis, while a symptom inventory and PSA in selected patients are recommended. Serum creatinine, uroflow, voiding diary, post void residual and sexual function questionnaire are optional. Unless there is an indication, other related tests are not recommended. Treatment choices should be governed by the severity of the symptoms, bother and patient preference. Guidelines for medical, surgical and minimally invasive treatment as well as special considerations are described in terms of guideline, option and recommendation. CONCLUSIONS: Diagnostic and treatment guidelines for BPH reflect the Canadian social priorities, economics, socialized medical practice, manpower issues, and medicolegal considerations.

Canada↗
PubMed2005

Natural history of urinary tract infection in a primary care environment in Canada.

OBJECTIVE: To characterize the natural history of uncomplicated urinary tract infection (uUTI) in a Canadian primary care environment from the patient's perspective. MATERIALS AND METHODS: Female patients (n = 2323) with symptoms of uUTI were recruited by 581 family physicians who collected baseline demographic and clinical data and prescribed 500 mg/day extended release ciprofloxacin (Cipro XL). Follow-up data were collected 4 and 10 days later by patient telephone interview assessing uUTI symptoms, medication compliance, time to symptom resolution, impact on usual activities and overall satisfaction. RESULTS: Patients (mean age 40) had on average 3.56 uUTI symptoms at baseline, the most common of which was frequency (94% of patients). The mean duration of symptoms was 4.9 days. Sixty-three percent of patients reported an impact of uUTI on usual activities prior to antibiotic therapy with a mean impact score of 4.33 {scale 0 to 10 (maximum)}. At day 4, uUTI symptoms had decreased to 0.74/patient, 71.5% of patients reported symptom resolution, while medication compliance was 97%. By day 10, uUTI symptoms had decreased further to 0.42/patient, 84.3% of patients had symptom resolution and only 13% reported a residual impact on usual activities (mean impact score, 0.76). Patients showed high levels of satisfaction (> 80%) with all aspects of therapy. CONCLUSIONS: Patients wait almost 5 days before seeking medical attention for uUTI and by that time symptoms can significantly impact normal activities. This assessment of symptoms and outcomes of uUTI provides physicians with a better view of the impact of infection on patient's lives.

Adult↗
PubMed2005

Early symptom improvement of benign prostatic hyperplasia (BPH) treated with once daily alfuzosin.

INTRODUCTION AND OBJECTIVES: A novel slow release formulation of alfuzosin should improve compliance by reducing dosing to one 10 mg tablet per day. The current study examined efficacy, at 9 days and 3 months, and safety of this formulation of alfuzosin in BPH patients. METHODS: ALF-X was a 3-month, non-comparative, observational study of 353 BPH patients from 39 Canadian Urology centres. RESULTS: At baseline (BL), mean age was 63.1+/-9.01 years, 92.6% of patients were Caucasian, 3.4% had a history of acute urinary retention, mean duration of the micturition disorder was 48.6+/-54.15 months, and mean PSA was 3.3+/-6.65 ng/mL. Mean total International Prostate Symptom Score (I-PSS) decreased from 17.5 at BL to 10.4 at M3--an improvement of 7.1+/-6.82 points (40.6%, p < 0.001), mostly occurring (27.0%, p < 0.001)) during the first 9 days. Mean Quality of Life Assessment Index improved by 0.7+/-1.39 points between BL and D9 (17.5%, p < 0.001), and by 1.5+/-1.52 points between BL and M3 (37.5%, p < 0.001). The proportion of 'mild' I-PSS patients increased from 11.8% (BL) to 29.7% (D9) to 39.0% (M3); those with 'severe' I-PSS decreased from 37.8% (BL) to 14.5% (D9) to 9.4% (M3). Of 144 patients with nocturia (>2 nightly voidings) at D1, 51.4% improved to < or = 2 nightly voidings at D9, and 60.4% at M3. Adverse events related to alfuzosin occurred in 7.8% of patients; 2.0% experienced serious adverse events. There were no vasodilatory events related to alfuzosin or deaths. CONCLUSIONS: In routine clinical practice, slow-release alfuzosin is associated with a significant improvement in LUTS, and frequency of nocturia, and an excellent safety profile.

Adrenergic alpha-Antagonists↗
PubMed2005

Practical management of recurrent urinary tract infections in premenopausal women.

Recurrent urinary tract infections (UTIs) are a major healthcare concern for premenopausal, healthy, sexually active women. A practical approach to the management and prevention of recurrent UTIs should be simple, practical, and cost effective. Low-dose or postcoital antimicrobial therapy can be effective for women with constellations of many recurrent UTIs, but for women with 2 to 4 UTIs per year, the most cost-effective and empowering management strategy is patient-initiated antimicrobial treatment.

Journal Article↗
PubMed2005

alpha-Blockers for Treatment of the Prostatitis Syndromes.

The prostatitis syndromes are among the most common and frustrating clinical challenges for urologists in outpatient practice. Available treatment, especially for the chronic prostatitis syndromes, is poor, with no standard therapy producing significant cure rates. alpha-Blocker therapy has been advocated (with various levels of evidence) as a treatment modality for all categories of the prostatitis syndromes. This article reviews the evidence supporting the use of alpha-blocker therapy in patients with prostatitis. Further trials of longer duration, perhaps employing combination therapies, are indicated to better evaluate the role of alpha-blockers in the management of the prostatitis syndromes.

Journal Article↗
PubMed2004

Clinical characterization of the prostatitis patient in Italy: a prospective urology outpatient study.

A prospective multi-center Italian urology outpatient survey, undertaken to determine the prevalence of prostatitis in Italy, provided an ideal opportunity to identify and characterize the typical prostatitis patient presenting to Italian urologists. A total of 70 urologists, representing a cross section of urologic centers in Italy, counted and recorded the overall total male patients reported in the clinic and the overall total patients diagnosed with prostatitis over a 5 week period in late 2001. Data on demographics, previous diagnoses, symptoms (frequency and severity), quality of life, physical examination and laboratory data were prospectively collected. A total of 1,148 patients were identified with prostatitis (12.8%). Of these, 1,074 patients had complete data and could be included in this characterization analysis. The mean age of the prostatitis patients was 47.1 years (range 16-83); two thirds had experienced their first symptom within the last year. A family history of prostatitis was reported by 20.4%. The most common urinary diseases were benign prostatic hyperplasia (17.4%), recurrent urinary tract infection (11.2%) and urinary calculogenesis (11.1%), while the most common concurrent diseases were diabetes (7.2%) and depression (6.8%). The most frequently reported and most severe symptoms at the time of evaluation were irritative voiding symptoms, perineal and suprapubic pain and discomfort. Over three quarters of the patients were dissatisfied with their quality of life. Bacteria were cultured in 15.6%, 17.7% and 14.0% of expressed prostatic secretions, urine specimens after prostatic massage and semen specimens, respectively. Prostatitis is a common outpatient diagnosis, comprising over 10% of male outpatient visits to urologists in Italy. This comprehensive characterization of the typical prostatitis patient diagnosed in routine urological outpatient practice can be employed to generate hypothesis-driven studies in diagnosis and treatment.

Adult↗
PubMed2004

Ciprofloxacin or tamsulosin in men with chronic prostatitis/chronic pelvic pain syndrome: a randomized, double-blind trial.

BACKGROUND: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) in men is principally defined by pain in the pelvic region lasting more than 3 months. No cause of the disease has been established, and therapies are empirical and mostly untested. Antimicrobial agents and alpha-adrenergic receptor blockers are frequently used. OBJECTIVE: To determine whether 6-week therapy with ciprofloxacin or tamsulosin is more effective than placebo at improving symptoms in men with refractory, long-standing CP/CPPS. DESIGN: Randomized, double-blind trial with a 2 x 2 factorial design comparing 6 weeks of therapy with ciprofloxacin, tamsulosin, both drugs, or placebo. SETTING: Urology outpatient clinics at 10 tertiary care medical centers in North America. PATIENTS: Patients were identified from referral-based practices of urologists. One hundred ninety-six men with a National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score of at least 15 and a mean of 6.2 years of symptoms were enrolled. Patients had received substantial previous treatment. MEASUREMENTS: The authors evaluated NIH-CPSI total score and subscores, patient-reported global response assessment, a generic measure of quality of life, and adverse events. INTERVENTIONS: Ciprofloxacin, 500 mg twice daily; tamsulosin, 0.4 mg once daily; a combination of the 2 drugs; or placebo. RESULTS: The NIH-CPSI total score decreased modestly in all treatment groups. No statistically significant difference in the primary outcome was seen for ciprofloxacin versus no ciprofloxacin (P = 0.15) or tamsulosin versus no tamsulosin (P > 0.2). Treatments also did not differ significantly for any of the secondary outcomes. LIMITATIONS: Treatment lasting longer than 6 weeks was not tested. Patients who had received less pretreatment may have responded differently. CONCLUSION: Ciprofloxacin and tamsulosin did not substantially reduce symptoms in men with long-standing CP/CPPS who had at least moderate symptoms.

Adrenergic alpha-Antagonists↗
PubMed2004

Acupuncture for chronic prostatitis/chronic pelvic pain syndrome.

Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is prevalent in urological practice and has a significant impact on quality of life. Standard therapies often fail to achieve sustainable amelioration of symptoms. This article attempts to show that neuromodulatory treatment in the form of electroacupuncture can be a minimally invasive and effective treatment for CP/CPPS that is refractory to standard therapies. This neuromodulatory therapy lends support to the hypothesis that the end stage of CP/CPPS may be a neuropathic pain syndrome.

Acupuncture Points↗
PubMed2004

Interstitial cystitis: a chronic pelvic pain syndrome.

Interstitial cystitis, an enigmatic chronic pelvic pain syndrome that occurs primarily in women, is much more common than originally believed. Its etiology is unknown, its evaluation and diagnosis remain controversial, and its treatment is largely empiric. Recent basic and clinical research is unlocking some of the mystery surrounding this clinical syndrome. Diagnostic awareness, willingness to consider recently studied therapies, and reasonable therapeutic expectations on the part of both the physician and the patient seem to be the key to successful management of this condition.

Chronic Disease↗
PubMed2004

Sustained decrease in incidence of acute urinary retention and surgery with finasteride for 6 years in men with benign prostatic hyperplasia.

PURPOSE: We determined the effect of long-term treatment with finasteride on the incidence of acute urinary retention (AUR) and benign prostatic hyperplasia (BPH) related surgery in men with BPH. MATERIALS AND METHODS: The Proscar (Merck and Co., Inc., Whitehouse Station, New Jersey) Long-Term Efficacy and Safety Study (PLESS) was comprised of 3040 men with enlarged prostates, moderate to severe symptomatic BPH and no clinical evidence of prostate cancer. Patients were randomized to placebo or 5 mg finasteride daily for 4 years. Of the 3016 randomized patients with available efficacy data 62% completed the original 4-year study (1006 on finasteride and 891 on placebo) and 89% of these (908 from the original finasteride arm and 785 from the placebo arm) continued in a 2-year open extension on finasteride. Followup was attempted in discontinued patients. Complete 6-year outcomes data, including 6-year followup in 770 men who had discontinued treatment during years 1 to 6, were available for 2463 (82%) of the 3016 originally randomized patients. RESULTS: For patients on continuous finasteride treatment the decrease in incidence of AUR and/or BPH related surgery in the 4-year base study was sustained during the open extension. In patients who were switched from placebo to finasteride in the extension, the incidence of AUR and/or BPH related surgery was similar to that in the continuous finasteride arm. CONCLUSIONS: The 6-year data from PLESS confirmed and further extended the findings from the original 4-year trial, demonstrating that finasteride treatment led to a sustained decrease in the incidence of AUR and/or BPH related surgery in men with BPH and enlarged prostates.

Acute Disease↗
PubMed2004

Treatment of chronic prostatitis/chronic pelvic pain syndrome with tamsulosin: a randomized double blind trial.

PURPOSE: We compared the efficacy of tamsulosin with placebo for the treatment of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). MATERIALS AND METHODS: In a double blind phase II trial, 58 patients 55 years old or younger with moderate to severe CP/CPPS were randomized to receive 0.4 mg tamsulosin or placebo for 6 weeks. Patients were assessed on days -14 and -1 during a 2-week washout, and on days 15 and 45. The primary end point was the change from baseline in total National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score on day 45. Secondary end points were the change from baseline in total NIH-CPSI score on day 15 and the change from baseline in pain, urinary symptoms and quality of life/impact domains of the NIH-CPSI on days 15 and 45. Analyses of responders were performed post hoc. RESULTS: On day 45 the treatment effect (difference between treatment groups in change from baseline) was -3.6 (p = 0.04) in favor of tamsulosin. The overall effect of tamsulosin was a function of the baseline total NIH-CPSI score. Treatment effect increased significantly as the baseline score increased (for total NIH-CPSI p <0.01). Tamsulosin efficacy was superior to placebo at the 75th percentile of baseline score for the total NIH-CPSI score (-8.3, p <0.01), the pain domain (-2.9, p = 0.02), the urinary symptoms domain (-2.3, p <0.01) and the impact/quality of life domain (-2.1, p = 0.02). The efficacy of tamsulosin increased with time (no significant treatment difference at 15 days) and tamsulosin was well tolerated. CONCLUSIONS: Tamsulosin was superior to placebo in providing symptomatic relief in men with CP/CPPS, particularly in those with more severe symptoms.

Adrenergic alpha-1 Receptor Antagonists↗