Comparative efficacy of two alpha-adrenoreceptor antagonists, doxazosin and alfuzosin, in patients with lower urinary tract symptoms from benign prostatic enlargement.

OBJECTIVES: To compare doxazosin and alfuzosin in patients with moderate to severe lower urinary tract symptoms (LUTS) suggestive of bladder outlet obstruction. PATIENTS AND METHODS: In all, 210 men with LUTS were randomized to receive doxazosin 1-8 mg once daily or alfuzosin 5-10 mg divided in two or three daily doses in a 14-week, multicentre, double-blind, baseline-controlled, dose-titration study. The International Prostate Symptom Score (IPSS) and maximum urinary flow rate were used to assess the efficacy of the treatment. RESULTS: At study completion, the mean dose of doxazosin was 6.1 mg/day and alfuzosin 8.8 mg/day. The least squares mean (se) change from baseline in total IPSS was -9.23 (0.6) for doxazosin and -7.45 (0.6) (both P < 0.001) for alfuzosin. The respective mean change from baseline in irritative symptoms was -3.5 (0.2) and -2.8 (0.3) (both P < 0.001). The differences between the treatment groups were statistically significant in favour of doxazosin (total IPSS, P = 0.036; irritative symptoms, P = 0.049). The improvement between groups was also significantly different for postvoid residual urine volume, at -29.19 (8.6) and + 9.59 (8.9) mL for doxazosin and alfuzosin, respectively (P = 0.002). Improvements in mean and maximum urinary flow rates were similar for both treatments, at + 1.5 and + 1.2, and + 2.8 and + 2.5 mL/s, respectively. Doxazosin and alfuzosin were both well tolerated, with most all-cause adverse events reported as mild or moderate. CONCLUSIONS: The mean doses of doxazosin and alfuzosin used in this study were not equipotent. Doxazosin 6.1 mg/day produced significantly greater improvements than alfuzosin 8.8 mg/day in total and irritative urinary symptom scores and postvoid residual urine volume in men with moderate to severe LUTS. Changes in maximum and mean flow rates were comparable. Doxazosin and alfuzosin were both well tolerated.

Hydrophilic versus non-coated catheters for intermittent catheterization.

Since Lapides reintroduced clean intermittent catheterization (CIC) in 1972, this procedure has been used routinely in individualized programmes for bladder evacuation in various bladder disorders. It has been suggested that in clinical practice hydrophilic catheters are preferable to non-coated catheters. In reviewing the literature on CIC, many of the reports were found to rely on data from non-randomized retrospective studies. In some recent prospective studies, involving a limited number of patients, hydrophilic and non-coated catheters have been evaluated and compared, especially with regard to bacteriuria and urethral irritation. The available data indicate that using hydrophilic catheters for CIC may induce lower rates of bacteriuria and long-term urethral complications such as urethral strictures. However, to reach a reliable conclusion about the supposed advantage of the hydrophilic catheters, there is a need for a prospective, randomized long-term multicentre study. It is important in such a study to define patient characteristics including age, gender, diagnosis of bladder dysfunction, reason for CIC, physical and mental handicap, manual dexterity and previous treatments. Effect parameters should include number of catheterizations, urinary tract infection, early and long-term urethral complications, patient satisfaction, preferences and dropout rates. It is obligatory to include factors such as cost-benefit and cost-effectiveness.

The accuracy of the frequency-volume chart: comparison of self-reported and measured volumes.

OBJECTIVE: To assess the accuracy of frequency-volume charts recorded by patients with voiding symptoms by comparing self-reported voiding data with the volumes of urine collected in same period. PATIENTS AND METHODS: The study comprised 18 patients (median age 63 years, range 20-80) and lasted 3 days, during which the patients recorded their fluid intake and voided volumes, and collected 24 h urine samples. RESULTS: The recorded volumes exceeded or underestimated the collected volume in 49% and 51%, respectively, of the samples, but the agreement between the accumulated daily voiding volumes on the charts and the volumes collected was acceptable. The median difference between volumes recorded on the charts and collected as samples was 100 (0-1450) mL per 24 h or 10 (0-117) mL per voiding (not significant). The median daily variation of creatinine in the urine was 1.1 (0.1-9.4) mmol (not significant), indicating that the 24 h collection periods were respected. CONCLUSION: Recordings on frequency-volume charts are valid and useful in the investigation of patients with voiding symptoms.

Estramustine phosphate versus placebo as second line treatment after orchiectomy in patients with metastatic prostate cancer: DAPROCA study 9002. Danish Prostatic Cancer Group.

PURPOSE: We compared the effect of 560 mg. estramustine phosphate daily to placebo as a supplement to standard palliative therapy in patients with progressive disease after bilateral orchiectomy as first line therapy for metastatic prostate cancer. MATERIALS AND METHODS: In a double-blind multicenter study 131 patients with progressing metastatic hormone refractory prostate cancer were randomized to receive 280 mg. estramustine phosphate 2 times daily versus placebo. End points were clinical progression and death. Adverse events, decrease in prostate specific antigen (PSA) and subjective response were also assessed. RESULTS: Adverse events were common in both groups but breast tenderness/gynecomastia and diarrhea were more frequent among patients in the estramustine phosphate group. Subjective responses were few (9 of 50 estramustine phosphate and 4 of 57 placebo cases, p = 0.15). Median observation time for survival was 43 months and 124 patients died. Median time to subjective progression and median overall survival did not differ significantly between the 2 groups at 4.6 and 9.4 months in the estramustine phosphate group versus 5.0 and 6.1 months in the placebo group. Of 61 patients in the estramustine phosphate group 29 achieved a reduction in PSA of more than 25% at 1 month of followup compared to only 3 of 68 receiving placebo. A decrease in PSA after 1 month correlated significantly with survival. CONCLUSIONS: Although this study did not prove estramustine phosphate to be superior to placebo in terms of protocol end points, it generates the hypothesis that prolonged survival may be achieved with estramustine phosphate treatment in a subgroup of patients and that this may be predicted by a decrease in PSA after 1 month of therapy.

The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction.

This article presents a standard system of terminology recently approved by the International Continence Society, the American Urogynecologic Society, and the Society of Gynecologic Surgeons for the description of female pelvic organ prolapse and pelvic floor dysfunction. An objective site-specific system for describing, quantitating, and staging pelvic support in women is included. It has been developed to enhance both clinical and academic communication regarding individual patients and populations of patients. Clinicians and researchers caring for women with pelvic organ prolapse and pelvic floor dysfunction are encouraged to learn and use the system.

Assessment of lower urinary tract symptoms in women by a self-administered questionnaire: test-retest reliability.

A self-administered questionnaire assessing female lower urinary tract symptoms and their impact on quality of life is described and validated, on 56 females in six participating departments. The patients answered two identical questionnaires on separate occasions before treatment. Test-retest reliability of the questionnaire, correlation between the symptoms and their troublesomeness, and the reproducibility of this correlation were assessed. The percentage of mistakes in answers to each of the questions varied from 1.8% to 49.1%, mainly owing to missing answers in the item groups: appliances, sexual function and social activities. Test-retest showed a repeat frequency of 50.0%-91.0% for symptoms and 44.6%-82.1% for trouble. A highly significant positive correlation was found between symptoms and trouble, which was most pronounced for questions concerning pain and incontinence. This correlation was consistent within time. The primary validation of this questionnaire is good. Its relevance as a basis for medical priority and clinical decision making remains to be investigated.

Absence of hepatic enzyme induction in prostate cancer patients receiving 'Casodex' (bicalutamide).

The potential for hepatic enzyme induction by bicalutamide ('Casodex') was assessed in an open study in prostate cancer patients. A single, oral dose of antipyrine 1000 mg was given before and after 12 weeks' bicalutamide therapy [once daily 50 mg (n = 7) or 150 mg (n = 11)] and its pharmacokinetics and metabolism were determined. Plasma or saliva samples were taken for the measurement of antipyrine concentration. Urine samples were assayed for antipyrine and its three major metabolites. With bicalutamide 50 mg, plasma antipyrine concentrations were maximal between 2 and 4 h after administration, declined in a log-linear manner and were unaffected by bicalutamide therapy; with bicalutamide 150 mg, saliva antipyrine concentrations were maximal between 2 and 4 h, declined in a log-linear manner, and were also unaffected by bicalutamide therapy. Antipyrine half-life was 16.3% shorter after bicalutamide 50 mg (p < 0.05); a small decrease (13.5%) in half-life after bicalutamide 150 mg was not statistically significant. A small reduction (18.6%, p < 0.05) in the AUCinfinity for antipyrine was noted after bicalutamide 150 mg. A statistically significant reduction in antipyrine recovery was seen with the lower bicalutamide dose (23.7%, p < 0.05). The statistically significant changes were small in absolute terms and showed no dose-response relationship. Bicalutamide does not significantly induce the hepatic enzymes responsible for antipyrine metabolism and has no obvious potential for producing clinically significant drug interactions due to enzyme induction.

Biofeedback treatment of bladder dysfunction in multiple sclerosis. A randomized trial.

Fifteen women and five men with bladder dysfunction due to multiple sclerosis were randomized to plus/minus biofeedback using bladder pressure and simultaneous EMG registration via surface electrodes. All the patients had behavioural modification, pharmacological adjustment and pelvis floor training. The number of incontinence episodes decreased and maximal cystometric capacity increased, while first sensation and pad test were unchanged. Subjective treatment results assessed by visual analogue scales for incontinence and obstrusive voiding symptoms were highly significant. However no biofeedback parameter was improved and no difference could be demonstrated between the two treatment groups. In conclusion the used biofeedback technique is insufficient and the 60 min. standardized pad weighing test is inadequate in this type of patients.

Long-term results of Danish Prostatic Cancer Group trial 86. Goserelin acetate plus flutamide versus orchiectomy in advanced prostate cancer.

In a multicenter trial conducted by the Danish Prostatic Cancer Group, 264 patients with advanced prostate cancer were randomized either to undergo bilateral orchiectomy or to receive combination treatment with goserelin acetate and flutamide. This report is an update of that study, covering a median follow-up for survival of 57 months. Of 262 patients who were evaluated, 208 have died. As noted in earlier analyses of this study, no differences in time to progression and cause-specific and overall survival could be identified between the two treatment groups. In conclusion, the combination of goserelin and flutamide was not clinically superior to bilateral orchiectomy in the treatment of advanced prostate cancer.

Pelvic floor muscle thickness measured by perineal ultrasonography.

Pelvic floor muscle thickness was assessed in nine healthy female physiotherapists by perineal sonography. All measurements were performed as triple-measurements. The aims were to assess the reliability of the measurements and to establish a reference material. The muscle thickness at rest and at contraction was 9.4 +/- 0.8 mm and 11.5 +/- 1.1 mm respectively (mean +/- SD). Contraction increased the thickness by 2.2 +/- 0.8 mm or 23 +/- 8%. The intra- and inter observer standard deviation of the estimate was in the range of 4-6%. In conclusion, we find the reliability of the measurements acceptable.

Bricker's ileal conduit urinary diversion with a simple non-refluxing uretero ileal anastomosis.

Fifty consecutive patients had ileal conduits constructed with a technically and quick simple antireflux ureteroileal anastomosis. Complications related to the ureteral implantation were studied retrospectively, and at follow-up (8 months-12 years later, median 3 years) conduit dysfunction and ureteral reflux were assessed in 18 patients out of the 25 patients who were still alive. Early complications and signs of late upper urinary tract deterioration were similar to those found after other operative techniques had been used. One patient had a postoperative urinary leak from the uretero ileal anastomosis. which was treated successfully by two weeks drainage. Hydronephrosis deteriorated in 18 (26%) of the renal units, remained unchanged in 39 (57%) and improved in 11 (16%). Increases in plasma creatinine concentrations up to 200 mumol/l were found in eight patients, and in one patient it increased from 300 to 420 mumol/l. Partial ureteral reflux was present in three (2 patients) of 33 ureters studied and minimal conduit dysfunction was found in 8 patients. In conclusion we find this method of urinary diversion to be quick, easy, and safe.

A phase III trial of zoladex and flutamide versus orchiectomy in the treatment of patients with advanced carcinoma of the prostate.

In a multicenter Phase III trial 264 patients with advanced prostatic cancer were randomized to either bilateral orchiectomy or treatment with zoladex supplemented by flutamide. Presently, median follow-up time is 30 months. A small difference in objective response was recorded in favor of the combination therapy, whereas no statistically significant difference was found in subjective response to therapy, time to progression, and overall survival. Adverse effects were more commonly encountered in the pharmacologically treated patients. It is concluded that the combination of zoladex plus flutamide is not clinically superior to orchiectomy in the treatment of patients with advanced carcinoma of the prostate.

The intraprostatic spiral. New treatment for urinary retention.

In a series of 45 consecutive patients with acute or chronic urinary retention, 41 were treated by insertion of an intraprostatic spiral using ultrasonic guidance under local anaesthesia. Insertion was successful in 35 patients and in 6 the spiral was inserted endoscopically. During a follow-up period of 12 months 8 patients died, all with a functioning spiral. The device was removed in 16 patients; in 6 cases the reasons for removal were related to the spiral and in 10 they were not. The spiral remained in situ in 17 patients and all had satisfactory voiding. This device is a good alternative to an indwelling catheter in patients awaiting prostatic surgery and also in those who are either unfit or unwilling to undergo prostatectomy.

Secondary treatment of advanced cancer of the prostate with Zoladex.

Twelve patients with advanced prostatic carcinoma and relapse following previous hormone manipulation therapy were treated with Zoladex-depot every 4 weeks. The treatment was well tolerated and the endocrine response was satisfactory. However, no clinically important improvement was obtained.

The intraprostatic spiral: a new device for insertion with the patient under local anesthesia and with ultrasonic guidance with 3 months of followup.

Acute or chronic urinary retention (median retention volume 1,000 ml.) was relieved successfully in 41 of 45 consecutive patients by insertion of an intraprostatic spiral with the patient under local anesthesia and with ultrasonic guidance. Insertion guided by ultrasound was successful in 35 patients (77 per cent). In 6 patients the spiral was inserted via the traditional endoscopic technique. During 3 months of followup the spiral remained in situ in 27 patients and in 6 it was repositioned. These 33 patients had free voiding with a median maximum flow rate of 13.6 ml. per second. Residual urine volume 1 month after insertion of the spiral was low (median 27 ml.). In 8 patients the spiral was removed during the observation period due to urinary incontinence or retention. The intraprostatic spiral is a favorable alternative to an indwelling catheter in patients awaiting an operation and in those with a high operative risk.

Reliability of voiding colpo-cysto-urethrography in female urinary stress incontinence before and after treatment.

Voiding colpo-cysto-urethrography was performed in 52 consecutive female patients with genuine urinary stress incontinence before treatment and in 50 of the patients after treatment. The patients were randomized to either pelvic floor training or surgery. Surgery included a colposuspension operation in patients with an anterior suspension defect and a vaginal repair in patients with a posterior suspension defect. All pre- and posttreatment examinations were reevaluated blindly by one observer 4 to 6 years later. The pretreatment radiologic reevaluation was in agreement with the original classification in 79 per cent and not in agreement in 21 per cent. Pelvic floor training did not change the degree of suspension defect systematically. The effect of squeezing was significantly improved following pelvic floor training. A colposuspension gave rise to a typical radiologic configuration of the bladder and urethra. A vaginal repair was not detectable radiologically and it did not correct a posterior descent. The degree of descent and the degree of incontinence were not correlated and it was not possible radiologically to distinguish treatment failures from treatment success.

Partial cystectomy for the myogenic decompensated bladder with excessive residual urine. Urodynamics, histology and 2-13 years follow-up.

Partial cystectomy was performed for myogenic decompensated bladder with excessive residual urine in 11 patients, in whom training instructions and pharmacological treatment were unsuccessful. Postoperatively, the patients were followed for 2-13 years (median 4 years). Both symptoms and residual urine were reduced permanently. Urodynamic testing had demonstrated underactive detrusor function in all. The supposed etiology was infravesical obstruction in 4, overdistension due to sensory bladder paresis in 3 and unknown in 4. Histological examination of the resected bladders showed focal degeneration of the smooth muscle cells (detrusor myopathy) in 7, transmural edema and vast deposits of collagen in 8, mastocytosis in 3 and eosinophilic cystitis in 1. In conclusion we regard partial cystectomy an alternative to clean intermittent self-catheterization in selected patients with excessive residual urine.

Flexible fiberoptic versus conventional cystourethroscopy in bladder tumor patients. A prospective study.

In 30 bladder tumor patients flexible fiberoptic and conventional cystourethroscopy was undertaken by two urologists in a random sequence. The findings at conventional cystoscopy, including histologic findings in biopsy and operative specimens, were taken to represent the true pathologic condition. Concordance was found in all but three patients, with solitary superficial grade II bladder tumors less than 2 mm in diameter that were overlooked at flexible cystoscopy. No discordance was observed in the evaluation of grade III or invasive bladder tumors. Flexible fiberoptic cystourethroscopy with urine cytology is recommended 1) as a follow-up investigation under local anesthesia in patients with non invasive bladder tumors and negative random biopsies, and 2) as a diagnostic procedure in poor-risk patients as an alternative to transabdominal ultrasonography.