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document
Use of an alpha 1-blocker , YM617 , in the treatment of benign prostatic hypertrophy . YM617 Clinical Study Group . A recently synthesized alpha 1-blocker , ( R ) ( - ) -5- [ 2- [ [ 2- ( o-ethoxyphenoxy ) ethyl ] amino ] propyl ] -2- methoxybenzenesulfonamide hydrochloride ( YM617 ) , was evaluated in 270 patients with benign prostatic hypertrophy in a double-blind study . After 2 weeks on placebo the patients were assigned at random to 4 groups : group P -- placebo , group L -- 0.1 mg. , group M -- 0.2 mg. and group H -- 0.4 mg. of YM617 . Comparing the placebo to the treatment period , subjective symptoms , such as nocturia and urgency , were significantly decreased in group H ( p less than 0.01 ) . The sensation of incomplete voiding was significantly improved in groups M and H ( p less than 0.01 ) . However , the differences among the groups were statistically insignificant . Residual urine volume was significantly decreased in groups L , M and H after instillation of saline into the bladder ( p less than 0.01 ) but not in group P. The maximum and average flow rates were significantly increased in groups L , M and H ( p less than 0.01 ) but not in group P. Average flow rate showed significant differences between groups M or H versus group P. Neither orthostatic hypotension nor a decrease in blood pressure was noted . Adverse side effects and changes in laboratory data were all slight and disappeared when the second tests were performed . In summary , the irritative and obstructive symptoms caused by benign prostatic hypertrophy were decreased and urodynamic studies were markedly improved by the alpha 1-blocker , YM617 . The drug seems to be useful in the treatment of patients with benign prostatic hypertrophy .
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Intervention_Pharmacological
alpha 1-blocker , YM617
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Intervention_Pharmacological
alpha 1-blocker , ( R ) ( - ) -5- [ 2- [ [ 2- ( o-ethoxyphenoxy ) ethyl ] amino ] propyl ] -2- methoxybenzenesulfonamide hydrochloride ( YM617 )
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Intervention_Control
placebo
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Intervention_Control
P -- placebo
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Intervention_Control
placebo
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Outcome_Physical
nocturia and urgency
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Outcome_Physical
sensation of incomplete voiding
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Outcome_Physical
Residual urine volume
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Outcome_Physical
maximum and average flow rates
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Outcome_Physical
Average flow rate
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Outcome_Adverse-effects
orthostatic hypotension
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Outcome_Adverse-effects
blood pressure
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Outcome_Physical
irritative and obstructive symptoms
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Outcome_Physical
benign prostatic hypertrophy
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Outcome_Physical
urodynamic studies
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Participant_Condition
benign prostatic hypertrophy
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Participant_Sample-size
270
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Participant_Sample-size
benign prostatic hypertrophy
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Participant_Sample-size
benign prostatic hypertrophy