| Effect of nightly versus on-demand vardenafil on recovery of erectile function in men following bilateral nerve-sparing radical prostatectomy. | |
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MedLine Citation:
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PMID: 18640769 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: To date, no data have been available from large, well-designed trials comparing on demand and nightly dosing of phosphodiesterase type 5 (PDE5) inhibitors on recovery of erectile function in postprostatectomy patients with erectile dysfunction (ED). OBJECTIVE: To investigate the effect of early postoperative dosing with vardenafil, administered either nightly or on demand, compared with placebo on recovery of erectile function in men with ED following bilateral nerve-sparing radical prostatectomy (NSRP) surgery. DESIGN, SETTING, AND PARTICIPANTS: A randomised, double-blind, double-dummy, multicentre, parallel group study conducted at 87 centres across Europe, Canada, South Africa, and the United States. For inclusion, patients had to be scheduled to undergo bilateral NSRP within 1 mo of screening and have a normal International Index of Erectile Function erectile function domain (IIEF-EF) score of > or =26 at screening. A total of 628 men, aged 18-64 yr, were randomised to treatment. Study design consisted of a 9-mo double-blind treatment period, a 2-mo single-blind washout period, and an optional 2-mo open-label period. INTERVENTION: Patients received placebo, nightly vardenafil, or on demand vardenafil. MEASUREMENTS: Primary outcome measure was the percentage of subjects with an IIEF-EF score of > or =22 after the 2-mo washout period. Secondary variables included mean per-patient success rates for Sexual Encounter Profile (SEP) questions 2 and 3. RESULTS AND LIMITATIONS: No statistically significant differences were observed among treatment groups in the proportion of patients with an IIEF-EF score of > or =22 or in SEP3 success rates after the washout period. On-demand vardenafil treatment resulted in significantly greater IIEF-EF scores and better SEP3 response rates than placebo over the entire treatment period. CONCLUSIONS: In this study of men with ED following bilateral NSRP, vardenafil was efficacious when used on demand, supporting a paradigm shift towards on demand dosing with PDE5 inhibitors in this patient group. TRIAL REGISTRATION: European clinical trials database (EudraCT; available at http://eudract.emea.europa.eu/). Trial registration number: 11336. |
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Authors:
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Francesco Montorsi; Gerald Brock; Jay Lee; JoAnn Shapiro; Hendrik Van Poppel; Markus Graefen; Christian Stief |
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Publication Detail:
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Type: Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't Date: 2008-07-09 |
Journal Detail:
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Title: European urology Volume: 54 ISSN: 0302-2838 ISO Abbreviation: Eur. Urol. Publication Date: 2008 Oct |
Date Detail:
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Created Date: 2008-09-08 Completed Date: 2009-01-15 Revised Date: 2009-07-30 |
Medline Journal Info:
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Nlm Unique ID: 7512719 Medline TA: Eur Urol Country: Switzerland |
Other Details:
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Languages: eng Pagination: 924-31 Citation Subset: IM |
Affiliation:
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Division of Urology, Universita Vita Salute San Raffaele, Via Olgettina 60, Milan, Italy. montorsi.francesco@hsr.it |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Double-Blind Method Erectile Dysfunction / drug therapy*, etiology* Humans Imidazoles / administration & dosage* Male Middle Aged Phosphodiesterase Inhibitors / administration & dosage* Piperazines / administration & dosage* Prostate / innervation Prostatectomy / adverse effects*, methods* Recovery of Function Sulfones / administration & dosage Triazines / administration & dosage |
| Chemical | |
Reg. No./Substance:
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0/Imidazoles; 0/Phosphodiesterase Inhibitors; 0/Piperazines; 0/Sulfones; 0/Triazines; 224785-90-4/vardenafil |
| Comments/Corrections | |
Comment In:
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Nat Clin Pract Urol. 2009 Jan;6(1):14-5
[PMID:
19065139
]
Eur Urol. 2009 May;55(5):e95-6; author reply e97-8 [PMID: 19081174 ] |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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