Randomised, placebo controlled, double blind study of alfuzosin SR in patients undergoing trial without catheter following acute urinary retention. Sustained-release alfuzosin and trial without catheter after acute urinary retention: a prospective, placebo-controlled. Efficacy and safety of a dual inhibitor of 5-alpha-reductase types 1 and 2 (dutasteride) in men with benign prostatic hyperplasia. The economic impact of using alfuzosin 10 mg once daily in the management of acute urinary retention in the UK: a 6-month analysis.
Acute urinary retention caused by bladder outlet obstruction resulting from prostatic enlargement is one of the commonest causes for acute admission to urology wards. More recently, there has been a trend to commence treatment with alpha-blockers after catheterisation followed by a trial without catheter (TWOC), in the hope that surgery may be avoided in a significant proportion of patients. There is no conclusive evidence of the efficacy of this treatment. We conducted a study to evaluate the efficacy of using the alpha-blocker alfuzosin SR in patients with acute urinary retention.
                All patients presenting with acute urinary retention to our unit were included in the trial. Exclusion criteria included patients with known bladder or prostate malignancy, bladder calculi, urinary tract infections, urethral stricture or patients on alpha-blockers. A total of 81 patients consented and were randomised. Sixty-two patients completed the study. The retention volume was recorded. Trial medicine was recorded on a twice-daily dose and the first TWOC was carried out after a minimum of three doses or 36 hours after admission. TWOC was considered successful on voiding with a residual volume of <200 ml. Unsuccessful patients were recatheterised and discharged home on trial medication, and called for a second TWOC after 2 weeks. Successful patients were continued on alpha-blockers and failures were put on the operating list for TURP. Patients on active treatments were reviewed at 2 year.
                Of the 34 patients treated with alfuzosin SR, 17 (50%) resumed voiding and of the 28 patients from placebo group, 16 (57%) voided successfully. All 33 patients were continued open labelled on alfuzosin SR 5mg BD. Out of 33 patients, 13 (43%) had TURP within first year after TWOC and three died due to various medical causes. Out of remaining 17 patients, 15 attended for follow-up. The mean peak flow rate was 8.4 ml/s and the mean residual volume was 112 ml. Six patients (40%) required TURP for severe lower urinary tract symptoms (LUTS). So out of 28 patients followed at 2 year, 19 (68%) had TURP.
                These data do not support the routine use of alpha-blockers in patients with acute urinary retention. Also continuing use of alpha-blockers does not seem to prevent further requirements of TURP, although larger studies are needed to support this.
                Copyright 2002 Elsevier Science B.V. To establish whether the administration of sustained-release (SR) alfuzosin improves the outcome of a trial without catheter (TWOC) after an episode of acute urinary retention.
                In a prospective, randomized, placebo-controlled trial, 81 patients with acute urinary retention related to benign prostatic obstruction received either SR alfuzosin (n=40), an alpha1-selective blocker, given at a dose of 5 mg twice daily, or placebo (n=41) for 48 h. The catheter was removed after 24 h of treatment. The main outcome measurement was success or failure of the TWOC. At the end of this double-blind phase the patients were followed up on an open basis.
                After removal of the catheter, 42% of patients voided successfully, 22 of 40 (55%) with SR alfuzosin and 12 of 41 (29%) with placebo (P=0.03). The mean age of patients voiding successfully, regardless of treatment group, was 68. 4 years, whilst the mean age of those who were not successful was 72. 9 years (P=0.015). In an intention-to-treat analysis of outcome adjusted for this age difference, the benefit in favour of those receiving SR alfuzosin was not significant, but at P=0.052 there was a strong suggestion of a positive treatment effect. The observed benefit remained significant in a per-protocol analysis adjusted for age. Taken together, these results indicate that treatment with SR alfuzosin was effective and that the observed benefit was not simply the effect of age difference between the groups. Of the 34 patients who voided successfully 23 (68%) required no further intervention within a mean follow-up of 7 months.
                Treatment with SR alfuzosin is effective in improving the success rate of a TWOC after an episode of acute urinary retention, although older patients are less likely to void successfully. By reducing the numbers of men sent home with urinary catheters, such treatment may result in a reduction in the associated perioperative morbidity in those undergoing prostatic surgery, and is clearly desirable for the patients' comfort and convenience. To study the efficacy and safety of dutasteride, a dual inhibitor of the 5-alpha-reductase isoenzymes types I and II.
                A total of 4325 men (2951 completed) with clinical benign prostatic hyperplasia, moderate to severe symptoms (American Urological Association-Symptom Index score of 12 points or greater), a peak flow rate of 15 mL/s or less, a prostate volume of 30 cm3 or greater (as measured by transrectal ultrasonography), and a serum prostate-specific antigen level of 1.5 to 10.0 ng/mL (inclusive) were enrolled into three identical clinical trials and randomized to 0.5 mg dutasteride daily or placebo. After a 1-month, single-blind, placebo lead-in, patients were followed up for 24 months in a double-blind trial with multiple interval assessments.
                At 24 months, serum dihydrotestosterone was reduced from baseline by a mean of 90.2% (median -93.7%; P <0.001), and the total prostate and transition zone volumes were reduced by a mean of 25.7% and 20.4%, respectively (P <0.001). The symptom score was improved by as early as 3 months, with pooled significance from 6 months onward (P <0.001) and a reduction of 4.5 points (21.4%) at 24 months (P <0.001). The maximal flow rate improved significantly from 1 month (P <0.01), with an increase of 2.2 mL/s reported at 24 months (P <0.001). Hence, the risk reduction of acute urinary retention was 57% and the risk reduction of benign prostatic hyperplasia-related surgical intervention was 48% compared with placebo. The drug was well tolerated.
                Dutasteride is a potent inhibitor of dihydrotestosterone production that is safe and effective in terms of the reduction of prostate volume and symptoms, flow rate improvement, and the reduction of the risk of acute urinary retention and surgery during a 24-month study period. To calculate the economic consequences of using alfuzosin 10 mg once daily for managing acute urinary retention (AUR) related to benign prostatic hyperplasia (BPH).
                We examined whether alfuzosin use during hospitalization for AUR and for 6 months after a successful trial without catheter (TWOC) is cost effective compared to placebo and immediate prostatectomy, from the perspective of patients managed in the National Health Service (NHS) in the UK. A decision-analysis model was developed to estimate the costs of various treatment options within the first 6 months after a first episode of AUR. Clinical data were obtained from a large randomized clinical trial comparing alfuzosin 10 mg with placebo, and from published reports. Cost data were obtained from both NHS and resource-use data gathered during the clinical trial. A Monte Carlo analysis, allowing variability in all uncertain variables of the model, was used to calculate the uncertainty surrounding the results.
                Treating patients with alfuzosin during initial hospitalization for AUR and in the first 6 months after a successful TWOC generates a cost-saving of pounds 349 relative to placebo. Savings related to immediate prostatectomy were pounds 892; both savings were significant (P < 0.05). Alfuzosin treatment was associated with a lower rate of prostatectomy after discharge from hospital after a successful TWOC.
                Treatment with alfuzosin 10 mg once daily before and after a successful TWOC has both clinical and economic benefits. It decreases the need for emergency surgery for BPH and reduces treatment costs in the first 6 months.
The limited available evidence suggests that alpha blockers increase success rates of TWOC. Alpha blocker side effects are low and comparable to placebo. It is uncertain whether alpha blockers reduce the risk of recurrent urinary retention and need for prostate surgery. The cost effectiveness and recommended duration of alpha blocker treatment after successful TWOC remains unknown. There are a lack of internationally agreed outcome measures for what constitutes successful TWOC. This makes meta-analysis difficult. More randomised clinical trials are needed to address these issues.