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Efficacy and safety of tamsulosin for treating lower urinary tract symptoms associated with benign prostatic hyperplasia: a multicenter, randomized, controlled, open-label non-inferiority study.

ABSTRACT: To compare the efficacy and safety of Sulosin D (PACIFICPHARMA, Korea) and Harnal D (ASTELLAS PHARMA KOREA, Korea) in treating patients with lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH).This randomized, controlled, open-label, multicenter non-inferiority study was conducted at four sites in Korea. We randomly assigned 123 patients with an International Prostate Symptom Score (IPSS) ?12 to receive either Sulosin D or Harnal D treatment for 8 weeks. The primary outcome was the mean change in IPSS from baseline to endpoint. Secondary outcomes were the mean change from baseline to endpoint in IPSS quality of life subscores, maximum uroflowmetry (Qmax), and post-voiding residuals (PVR).In all, 123 patients were randomly assigned (60 Sulosin D and 63 Harnal D). The changes in the total IPSS from baseline in the Sulosin D- and Harnal D-treated groups were -4.97 and -4.03, respectively. There were significant decreases compared with baseline in both groups. The mean difference (Sulosin D - Harnal D) was -0.91 (with a two-sided 90% confidence interval), inferring that Sulosin D was not inferior to Harnal D. The mean changes in the IPSS subscore, Qmax, and PVR from baseline were comparable between the groups (both p>0.05). During the treatment periods, the incidence of adverse events was 23.33% and 34.92% in the Sulosin D and Harnal D groups, respectively (p=0.1580).We demonstrate the non-inferiority of Sulosin D to Harnal D in patients with lower urinary tract symptoms associated with BPH.

SUBMITTER: Lee HS

PROVIDER: S-EPMC3312066 | biostudies-other | 2012 Mar

REPOSITORIES: biostudies-other

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Efficacy and safety of tamsulosin for treating lower urinary tract symptoms associated with benign prostatic hyperplasia: a multicenter, randomized, controlled, open-label non-inferiority study.

Lee Hyo Serk HS Kim Sae Woong SW Oh Seung-June SJ Choo Myung-Soo MS Lee Kyu-Sung KS

Korean journal of urology 20120319 3

<h4>Purpose</h4>To compare the efficacy and safety of Sulosin D (PACIFICPHARMA, Korea) and Harnal D (ASTELLAS PHARMA KOREA, Korea) in treating patients with lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH).<h4>Materials and methods</h4>This randomized, controlled, open-label, multicenter non-inferiority study was conducted at four sites in Korea. We randomly assigned 123 patients with an International Prostate Symptom Score (IPSS) ≥12 to receive either Sulosin D or ...[more]

PMID: 22468213

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Project description:This study aimed to investigate perceived ejaculatory function/satisfaction before treatment for lower urinary tract symptoms (LUTS)/benign prostatic hyperplasia (BPH) and to identify associations between specific categories of ejaculatory dysfunctions (EjDs) and LUTS. A total of 1574 treatment-naïve men with LUTS/BPH were included in this study. All patients underwent routine evaluation for LUTS/BPH including the International Index of Erectile Function and a 5-item questionnaire developed to assess ejaculatory volume/force/pain/satisfaction/latency time. Patients who had sexual intercourse over the past 4 weeks were classified as sexually active group. A total of 783 patients were categorized as sexually active group. Decreased ejaculatory volume and force were reported by 53.4% and 55.7% of 783 sexually active men, respectively. There was a strong correlation between ejaculatory volume and force. Ejaculatory pain/discomfort, premature ejaculation (PE), and delayed ejaculation (DE) were reported in 41.0%, 16.3%, and 41.4% of the patients, respectively. Over 40.0% of men without decreased ejaculation volume/force were satisfied with ejaculatory function, whereas approximately 6.0% of men with decreased volume/force were satisfied with ejaculatory function. About 30.0% of men with decreased volume/force had orgasmic dysfunction, while approximately 10.0% of men without decreased volume/force did. Decreased ejaculatory volume or force was associated with LUTS severity after adjusting for other influential factors including testosterone level, erectile function, and prostate size on ultrasonography, but PE or DE or ejaculatory pain/discomfort was not. In conclusion, a considerable portion of men with LUTS/BPH appear to have a variety of EjDs. Ejaculatory volume/force and satisfaction/orgasm do not always appear to be concordant. Ejaculatory volume or force is independently associated with LUTS severity, whereas PE or DE or ejaculatory pain/discomfort is not.

Project description:ContextSeveral newer device-based procedures have recently become available for treating men with lower urinary tract symptoms attributed to benign prostatic hyperplasia, but their effectiveness remains uncertain.ObjectiveTo assess the longer-term comparative effectiveness (defined as >12 mo of follow-up) of the newer treatment modalities prostatic urethral lift (PUL), transurethral prostate convective radiofrequency water vapor (Rezūm), Aquablation, and prostatic arterial embolization (PAE).Evidence acquisitionOvid Medline, the Cochrane Central Register of Controlled Trials (CENTRAL), and the Agency for Healthcare Research and Quality databases were searched through September 30, 2019; hand searches of references of relevant studies were also performed. Eligible studies were randomized controlled trials (RCTs) published in English language. We excluded observational studies.Evidence synthesisOne RCT (n = 91) found that patients undergoing PUL may be less likely to respond (risk ratio [RR] 0.8; 95% confidence interval [CI] 0.7-1.0; low certainty of evidence [CoE]) and have a higher mean International Prostate Symptom Score (IPSS; mean difference 6.1; 95% CI 2.2-10.0; low CoE) than those undergoing transurethral resection of the prostate (TURP). Among patients undergoing PAE, one small RCT (n = 30) reported similar IPSS response rates (RR 0.9; 95% CI 0.7-1.1; low CoE) and one trial (n = 107) found similar mean IPSS (-0.7; 95% CI -1.3 to 2.7; moderate CoE) scores to those among patients undergoing TURP. A single study on Aquablation reported 12 mo of follow-up only, and a single 3-mo trial compared Rezūm with sham treatment.ConclusionsThe current best evidence underlying these newer therapies is limited to few trials (PUL and PAE), short-term follow-up of 12 mo (Aquablation and Rezūm), or sham comparison only (Rezūm).Patient summaryEvidence for four of the newer surgical treatments for men with an enlarged prostate is limited to few small trials with short-term follow-up; only one trial compared a new treatment modality with sham surgery.

Dataset Information

Efficacy and safety of tamsulosin for treating lower urinary tract symptoms associated with benign prostatic hyperplasia: a multicenter, randomized, controlled, open-label non-inferiority study.

Publications

Efficacy and safety of tamsulosin for treating lower urinary tract symptoms associated with benign prostatic hyperplasia: a multicenter, randomized, controlled, open-label non-inferiority study.

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