Abstract:
OBJECTIVE:To evaluate the efficacy and tolerability of extended-release oxybutynin in combination with the alpha1-blocker tamsulosin in reducing lower urinary tract symptoms in men. PATIENTS AND METHODS:In this multicenter, double-blind trial performed between March 29, 2004, and June 22, 2005, 420 men aged 45 years or older with a total International Prostate Symptom Score (IPSS) of 13 or more and IPSS for storage of 8 or more were randomized to receive tamsulosin (0.4 mg/d) with either extended-release oxybutynin (10 mg/d) or placebo for 12 weeks. Eligibility requirements included a maximum flow rate of 8 mL/s or more with voided volume of 125 mL or more and a postvoid residual volume of 150 mL or less on 2 occasions. Postvoid residual volume and peak flow rates at weeks 4, 8, and 12 were measured. The primary end point was change from baseline in total IPSS after 12 weeks of treatment. Secondary outcomes included change in IPSSs for storage and quality of life. RESULTS:Tamsulosin combined with extended-release oxybutynin resulted in significantly greater improvement in total IPSS compared with tamsulosin and placebo after 8 (P=.03) and 12 (P=.006) weeks of treatment, and improved IPSS for storage and quality of life at all assessment points (P<.01). The incidence of postvoid residual volume higher than 300 mL was 2.9% (6/209) in patients receiving combination therapy compared with 0.5% (1/209) in patients receiving tamsulosin alone (P=.12). Occurrence of peak flow rates below 5 mL/s was 3.8% (8/209) for combination therapy and 5.7% (12/209) for tamsulosin alone (P=.49). CONCLUSION:In men with substantial storage symptoms, combination therapy with tamsulosin and extended-release oxybutynin demonstrated greater efficacy than and comparable safety and tolerability to tamsulosin monotherapy.
journal_name
Mayo Clin Procjournal_title
Mayo Clinic proceedingsauthors
MacDiarmid SA,Peters KM,Chen A,Armstrong RB,Orman C,Aquilina JW,Nitti VWdoi
10.4065/83.9.1002subject
Has Abstractpub_date
2008-09-01 00:00:00pages
1002-10issue
9eissn
0025-6196issn
1942-5546pii
S0025-6196(11)60603-4journal_volume
83pub_type
杂志文章,多中心研究,随机对照试验abstract:OBJECTIVE:To study the impact of parental leave on extending residency training and the timing of entrance into the specialty board certification examination system. METHODS:From June 3, 2005, through December 28, 2005, primary specialty board policies regarding parental leave, absence from training, and the timing of...
journal_title:Mayo Clinic proceedings
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journal_title:Mayo Clinic proceedings
pub_type: 杂志文章
doi:
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pub_type: 杂志文章,评审
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pub_type: 杂志文章,评审
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pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
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journal_title:Mayo Clinic proceedings
pub_type: 临床试验,杂志文章,随机对照试验
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