Randomized, double-blind, placebo-controlled study of postoperative nightly sildenafil citrate for the prevention of erectile dysfunction after bilateral nerve-sparing radical prostatectomy
Four weeks after bilateral nerve-sparing radical retropubic prostatectomy, men with normal erectile function before surgery were randomized to double-blind sildenafil (50 or 100 mg) or placebo nightly for 36 weeks, followed by an 8-week drug-free period before assessment of erectile function. Enroll...
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| Veröffentlicht in: | International journal of impotence research 2008-09, Vol.20 (5), p.479-486 |
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| container_title | International journal of impotence research |
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| creator | Padma-Nathan, H McCullough, A R Levine, L A Lipshultz, L I Siegel, R Montorsi, F Giuliano, F Brock, G |
| description | Four weeks after bilateral nerve-sparing radical retropubic prostatectomy, men with normal erectile function before surgery were randomized to double-blind sildenafil (50 or 100 mg) or placebo nightly for 36 weeks, followed by an 8-week drug-free period before assessment of erectile function. Enrollment was prematurely ceased and only 76 men completed because, assuming a placebo response rate similar to the published literature (for example, 34% in meta-analysis), the 25% response at blinded interim review suggested a lack of treatment effect. On the contrary, spontaneous erectile function (a combined score of ⩾8 for questions 3 and 4 of the International Index of Erectile Function and a positive response to ‘Were erections good enough for satisfactory sexual activity?’) occurred in only 4% of the placebo group (
n
=1 of 25) versus 27% (
n
=14 of 51,
P
=0.0156, Fisher's exact test) of the sildenafil group. Nightly sildenafil administration for 36 weeks after surgery markedly increased the return of normal spontaneous erections. |
| doi_str_mv | 10.1038/ijir.2008.33 |
| format | Article |
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n
=1 of 25) versus 27% (
n
=14 of 51,
P
=0.0156, Fisher's exact test) of the sildenafil group. Nightly sildenafil administration for 36 weeks after surgery markedly increased the return of normal spontaneous erections.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Alprostadil</subject><subject>Biological and medical sciences</subject><subject>Darkness</subject><subject>Dosage and administration</subject><subject>Double-blind studies</subject><subject>Drug therapy</subject><subject>Erectile dysfunction</subject><subject>Erectile Dysfunction - prevention & control</subject><subject>Gynecology. Andrology. Obstetrics</subject><subject>Health aspects</subject><subject>Humans</subject><subject>Impotence</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>original-article</subject><subject>Piperazines - adverse effects</subject><subject>Piperazines - pharmacology</subject><subject>Postoperative Care</subject><subject>Prevention</subject><subject>Prostate - innervation</subject><subject>Prostate - surgery</subject><subject>Prostatectomy</subject><subject>Prostatectomy - methods</subject><subject>Purines - adverse effects</subject><subject>Purines - pharmacology</subject><subject>Reproductive Medicine</subject><subject>rology</subject><subject>Sildenafil</subject><subject>Sildenafil Citrate</subject><subject>Sulfones - adverse effects</subject><subject>Sulfones - pharmacology</subject><subject>Urological surgery</subject><subject>Urology</subject><issn>0955-9930</issn><issn>1476-5489</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2008</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp1kl2P1CAUhhujcdfVO68NcaPebEdKCy2Xm41fySYmRq8bCocZJhQq0EnG_-Z_kzoTxzVruCAcnnMOvO8piucVXlW47t6arQkrgnG3qusHxXnVtKykTccfFueYU1pyXuOz4kmMW4wxxxV7XJxVHaO4I-158fOLcMqP5geoK6T8PFgoB2tcPk1WSBh8Kb1LwVsLCsU0qz3yGk0-Jj9BEMnsADmz3iS7R9FYBU5oY5E0KV8C0j6gtAE0BdiBS8a7JR0CyGQsILWPenbyd1zoBAENxua8ICxyEHZQxkkE49YoCGVkjk4ht86ETH7cPy0eaWEjPDvuF8W39---3nwsbz9_-HRzfVtK1rBUDpxJBU071A3TTJOBN7jDVGJJKNaYdjUMDITkmpOWU9YMA24JKCpahYmu64vizaFu7v59hpj60UQJ1goHfo5917aUY85JJi__Ibd-Di4_riesoXWd7Wkz9fK_VNXxriGMnUqthYXeOO2zpHJp3F9XHJOGsnqhVvdQeSkYTbYOshtwN-H1XwkbEDZtorfz4kG8C14dQJkljwF0PwUzirDvK9wvo9cvo9cvo9fXi0Yvjn-ahxHUCT7OWgZeHQERs5M6CCdN_MMRzEhXkUXC8sDFaXEewkmcexv_AjEW8zA</recordid><startdate>20080901</startdate><enddate>20080901</enddate><creator>Padma-Nathan, H</creator><creator>McCullough, A R</creator><creator>Levine, L A</creator><creator>Lipshultz, L I</creator><creator>Siegel, R</creator><creator>Montorsi, F</creator><creator>Giuliano, F</creator><creator>Brock, G</creator><general>Nature Publishing Group UK</general><general>Nature Publishing</general><general>Nature Publishing Group</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AN0</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7TK</scope></search><sort><creationdate>20080901</creationdate><title>Randomized, double-blind, placebo-controlled study of postoperative nightly sildenafil citrate for the prevention of erectile dysfunction after bilateral nerve-sparing radical prostatectomy</title><author>Padma-Nathan, H ; McCullough, A R ; Levine, L A ; Lipshultz, L I ; Siegel, R ; Montorsi, F ; Giuliano, F ; Brock, G</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c646t-b96cde47b346f6f2b940805c0c250f0583eb6eac9f9279564bb072ed5a7d02f33</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2008</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Alprostadil</topic><topic>Biological and medical sciences</topic><topic>Darkness</topic><topic>Dosage and administration</topic><topic>Double-blind studies</topic><topic>Drug therapy</topic><topic>Erectile dysfunction</topic><topic>Erectile Dysfunction - prevention & control</topic><topic>Gynecology. Andrology. Obstetrics</topic><topic>Health aspects</topic><topic>Humans</topic><topic>Impotence</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>original-article</topic><topic>Piperazines - adverse effects</topic><topic>Piperazines - pharmacology</topic><topic>Postoperative Care</topic><topic>Prevention</topic><topic>Prostate - innervation</topic><topic>Prostate - surgery</topic><topic>Prostatectomy</topic><topic>Prostatectomy - methods</topic><topic>Purines - adverse effects</topic><topic>Purines - pharmacology</topic><topic>Reproductive Medicine</topic><topic>rology</topic><topic>Sildenafil</topic><topic>Sildenafil Citrate</topic><topic>Sulfones - adverse effects</topic><topic>Sulfones - pharmacology</topic><topic>Urological surgery</topic><topic>Urology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Padma-Nathan, H</creatorcontrib><creatorcontrib>McCullough, A R</creatorcontrib><creatorcontrib>Levine, L A</creatorcontrib><creatorcontrib>Lipshultz, L I</creatorcontrib><creatorcontrib>Siegel, R</creatorcontrib><creatorcontrib>Montorsi, F</creatorcontrib><creatorcontrib>Giuliano, F</creatorcontrib><creatorcontrib>Brock, G</creatorcontrib><creatorcontrib>Study Group</creatorcontrib><creatorcontrib>on behalf of the Study Group</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>British Nursing Database</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>Neurosciences Abstracts</collection><jtitle>International journal of impotence research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Padma-Nathan, H</au><au>McCullough, A R</au><au>Levine, L A</au><au>Lipshultz, L I</au><au>Siegel, R</au><au>Montorsi, F</au><au>Giuliano, F</au><au>Brock, G</au><aucorp>Study Group</aucorp><aucorp>on behalf of the Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Randomized, double-blind, placebo-controlled study of postoperative nightly sildenafil citrate for the prevention of erectile dysfunction after bilateral nerve-sparing radical prostatectomy</atitle><jtitle>International journal of impotence research</jtitle><stitle>Int J Impot Res</stitle><addtitle>Int J Impot Res</addtitle><date>2008-09-01</date><risdate>2008</risdate><volume>20</volume><issue>5</issue><spage>479</spage><epage>486</epage><pages>479-486</pages><issn>0955-9930</issn><eissn>1476-5489</eissn><abstract>Four weeks after bilateral nerve-sparing radical retropubic prostatectomy, men with normal erectile function before surgery were randomized to double-blind sildenafil (50 or 100 mg) or placebo nightly for 36 weeks, followed by an 8-week drug-free period before assessment of erectile function. Enrollment was prematurely ceased and only 76 men completed because, assuming a placebo response rate similar to the published literature (for example, 34% in meta-analysis), the 25% response at blinded interim review suggested a lack of treatment effect. On the contrary, spontaneous erectile function (a combined score of ⩾8 for questions 3 and 4 of the International Index of Erectile Function and a positive response to ‘Were erections good enough for satisfactory sexual activity?’) occurred in only 4% of the placebo group (
n
=1 of 25) versus 27% (
n
=14 of 51,
P
=0.0156, Fisher's exact test) of the sildenafil group. Nightly sildenafil administration for 36 weeks after surgery markedly increased the return of normal spontaneous erections.</abstract><cop>London</cop><pub>Nature Publishing Group UK</pub><pmid>18650827</pmid><doi>10.1038/ijir.2008.33</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0955-9930 |
| ispartof | International journal of impotence research, 2008-09, Vol.20 (5), p.479-486 |
| issn | 0955-9930 1476-5489 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_877590992 |
| source | MEDLINE; EZB-FREE-00999 freely available EZB journals; SpringerLink Journals - AutoHoldings |
| subjects | Adolescent Adult Aged Alprostadil Biological and medical sciences Darkness Dosage and administration Double-blind studies Drug therapy Erectile dysfunction Erectile Dysfunction - prevention & control Gynecology. Andrology. Obstetrics Health aspects Humans Impotence Male Medical sciences Medicine Medicine & Public Health Middle Aged original-article Piperazines - adverse effects Piperazines - pharmacology Postoperative Care Prevention Prostate - innervation Prostate - surgery Prostatectomy Prostatectomy - methods Purines - adverse effects Purines - pharmacology Reproductive Medicine rology Sildenafil Sildenafil Citrate Sulfones - adverse effects Sulfones - pharmacology Urological surgery Urology |
| title | Randomized, double-blind, placebo-controlled study of postoperative nightly sildenafil citrate for the prevention of erectile dysfunction after bilateral nerve-sparing radical prostatectomy |
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