British Journalof Urology (1992), 70,40841 1 01992 British Journal of Urology
Is Indoramin an Effective Alternative to Prostatectomy? S. N. LLOYD, A. McMAHON, W. MULLER, J. F. BUCKLEY, R. F. DEANE, D. KIRK and K. F. KYLE Department of Urology, Western Infirmary, Glasgow
Summary-Alpha- 1-adrenergic antagonists are recommended for symptomatic treatment of patients awaiting prostatic surgery. Their efficacy has been confirmed in placebo controlled clinical trials, but to date no comparison of their effects with the results of subsequent prostatectomy has been made. Fifty-five patients awaiting prostatectomy were assessed (by symptom scores and peak urinary flow rates) prior to treatment, on indoramin 20 mg bd, and 2 months following prostatectomy. Side effects while taking indoramin were experienced by 36% of patients. Despite an overall improvement in mean symptom scores, 26% of patients with obstructive and 30% of those with irritative symptoms who were assessed while taking indoramin failed to experience any improvement. Of the 31 patients assessed while on indoramin and again following surgery, prostatectomy produced a greater symptomatic relief than indoramin. The increase in peak flow rate following prostatectomy was 11.7 ml/s compared with 3.2 ml/s on indoramin. However, 5 patients preferred to continue taking indoramin rather than proceeding to surgery. Indoramin is no substitute for prostatectomy. Although some patients might benefit from treatment while awaiting surgery, significant side effects may severely restrict its use for this purpose. The response to indoramin cannot be used as an accurate predictor of response to prostatectomy.
Indoramin is an alpha-1-adrenergic receptor antagonist which has been shown to be more effective than placebo in improving symptoms in patients with benign prostatic hyperplasia (lacovou and Dunn, 1987; Chow et al., 1990; Stott and Abrams, 1991). While controlled trials have demonstrated these apparent benefits, such studies usually involved selected patients and the tolerance and efficacy of indoramin in general urological practice are less clear. Having recently recruited patients for a large multi-centre trial of another alpha-1 receptor antagonist, we were aware that the majority of patients who might have been suitable for treatment were excluded from investigation because of the strict entry criteria imposed, and the results of that study might not be applicable to them. In addition, we know of no study directly comparing the efficacy of alpha receptor antagonists with prostatectomy. Accepted for publication 24 September 1991
The use of indoramin in an unselected group of patients awaiting prostatectomy, its value at predicting response and its effectiveness compared with the results of surgery have been monitored and the results are presented here. Patients and Methods A total of 55 patients who were on the waiting list for elective prostatectomy were treated with indoramin. Patients were excluded only if there were clear medical contraindications to alpha receptor antagonist therapy. Each patient was assessed by symptom score according to the method of Boyarsky et al. (1977), and by maximum urinary flow rates using a Urodyn 1000 (Dantec) uroflowmeter. Assessment was made prior to receiving indoramin 20 mg bd. The general practitioners were asked to prescribe the indoramin and to modify any existing antihypertensive therapy where appropriate in accordance with the data sheet recommendations
408
409
IS INDORAMIN AN EFFECTIVE ALTERNATIVE TO PROSTATECTOMY?
for the use of indoramin. Assessment of symptom scores and urinary flow rates was repeated after 2 months’ treatment on indoramin, usually just prior to prostatectomy. This assessment was repeated 2 months following surgery. For the purpose of statistical analysis, patients with Boyarsky scores of 2 or less for obstructive or irritative scores were not regarded as having significant symptoms. Urinary flow rates with voided volumes greater than 100 ml were preferred, but flow rates where the voided volume was less than 100 mi on 3 successive occasions were included for analysis if the tracing was considered representative of the patient’s normal voiding pattern. All statistical analyses were performed using Student’s paired t test, on the Minitab version 6 designed for the Apple Macintosh SE.
RHults Of the 55 patients who were prescribed indoramin, 20 experienced side effects (Table 1) and 7 stopped treatment as a result. Six more patients stopped because they failed to perceive any appreciable improvement in their symptoms and 1 patient was taken off medication following a myocardial infarction. There was an improvement in overall mean symptom scores which was statistically significant (P
Is Indoramin an Effective Alternative to Prostatectomy? S. N. LLOYD, A. McMAHON, W. MULLER, J. F. BUCKLEY, R. F. DEANE, D. KIRK and K. F. KYLE Department of Urology, Western Infirmary, Glasgow
Summary-Alpha- 1-adrenergic antagonists are recommended for symptomatic treatment of patients awaiting prostatic surgery. Their efficacy has been confirmed in placebo controlled clinical trials, but to date no comparison of their effects with the results of subsequent prostatectomy has been made. Fifty-five patients awaiting prostatectomy were assessed (by symptom scores and peak urinary flow rates) prior to treatment, on indoramin 20 mg bd, and 2 months following prostatectomy. Side effects while taking indoramin were experienced by 36% of patients. Despite an overall improvement in mean symptom scores, 26% of patients with obstructive and 30% of those with irritative symptoms who were assessed while taking indoramin failed to experience any improvement. Of the 31 patients assessed while on indoramin and again following surgery, prostatectomy produced a greater symptomatic relief than indoramin. The increase in peak flow rate following prostatectomy was 11.7 ml/s compared with 3.2 ml/s on indoramin. However, 5 patients preferred to continue taking indoramin rather than proceeding to surgery. Indoramin is no substitute for prostatectomy. Although some patients might benefit from treatment while awaiting surgery, significant side effects may severely restrict its use for this purpose. The response to indoramin cannot be used as an accurate predictor of response to prostatectomy.
Indoramin is an alpha-1-adrenergic receptor antagonist which has been shown to be more effective than placebo in improving symptoms in patients with benign prostatic hyperplasia (lacovou and Dunn, 1987; Chow et al., 1990; Stott and Abrams, 1991). While controlled trials have demonstrated these apparent benefits, such studies usually involved selected patients and the tolerance and efficacy of indoramin in general urological practice are less clear. Having recently recruited patients for a large multi-centre trial of another alpha-1 receptor antagonist, we were aware that the majority of patients who might have been suitable for treatment were excluded from investigation because of the strict entry criteria imposed, and the results of that study might not be applicable to them. In addition, we know of no study directly comparing the efficacy of alpha receptor antagonists with prostatectomy. Accepted for publication 24 September 1991
The use of indoramin in an unselected group of patients awaiting prostatectomy, its value at predicting response and its effectiveness compared with the results of surgery have been monitored and the results are presented here. Patients and Methods A total of 55 patients who were on the waiting list for elective prostatectomy were treated with indoramin. Patients were excluded only if there were clear medical contraindications to alpha receptor antagonist therapy. Each patient was assessed by symptom score according to the method of Boyarsky et al. (1977), and by maximum urinary flow rates using a Urodyn 1000 (Dantec) uroflowmeter. Assessment was made prior to receiving indoramin 20 mg bd. The general practitioners were asked to prescribe the indoramin and to modify any existing antihypertensive therapy where appropriate in accordance with the data sheet recommendations
408
409
IS INDORAMIN AN EFFECTIVE ALTERNATIVE TO PROSTATECTOMY?
for the use of indoramin. Assessment of symptom scores and urinary flow rates was repeated after 2 months’ treatment on indoramin, usually just prior to prostatectomy. This assessment was repeated 2 months following surgery. For the purpose of statistical analysis, patients with Boyarsky scores of 2 or less for obstructive or irritative scores were not regarded as having significant symptoms. Urinary flow rates with voided volumes greater than 100 ml were preferred, but flow rates where the voided volume was less than 100 mi on 3 successive occasions were included for analysis if the tracing was considered representative of the patient’s normal voiding pattern. All statistical analyses were performed using Student’s paired t test, on the Minitab version 6 designed for the Apple Macintosh SE.
RHults Of the 55 patients who were prescribed indoramin, 20 experienced side effects (Table 1) and 7 stopped treatment as a result. Six more patients stopped because they failed to perceive any appreciable improvement in their symptoms and 1 patient was taken off medication following a myocardial infarction. There was an improvement in overall mean symptom scores which was statistically significant (P
