Comparison of fesoterodine and tolterodine extended release for the treatment of overactive bladder: a head‐to‐head placebo‐controlled trial
Study Type – Therapy (RCT) Level of Evidence 1b OBJECTIVE To compare the efficacy and tolerability of fesoterodine 8 mg with tolterodine extended‐release (ER) 4 mg and placebo in a randomized clinical trial of patients with an overactive bladder (OAB). PATIENTS AND METHODS In this 12‐week double‐bli...
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| creator | Herschorn, Sender Swift, Steven Guan, Zhonghong Carlsson, Martin Morrow, Jon D. Brodsky, Marina Gong, Jason |
| description | Study Type – Therapy (RCT)
Level of Evidence 1b
OBJECTIVE
To compare the efficacy and tolerability of fesoterodine 8 mg with tolterodine extended‐release (ER) 4 mg and placebo in a randomized clinical trial of patients with an overactive bladder (OAB).
PATIENTS AND METHODS
In this 12‐week double‐blind, double‐dummy, placebo‐controlled, randomized clinical trial, eligible patients reported OAB symptoms for ≥3 months and recorded ≥8 voids and ≥1 urgency urinary incontinence (UUI) episode per 24 h in 3‐day bladder diaries at baseline. Patients were randomized in a 2:2:1 ratio to fesoterodine (4 mg for 1 week then 8 mg for 11 weeks); tolterodine ER 4 mg; or placebo (with sham dose escalation for tolterodine ER and placebo). Endpoints were changes from baseline to week 12 in UUI episodes (primary endpoint), total and nocturnal voids, urgency episodes, severe urgency episodes, and frequency‐urgency sum per 24 h; mean voided volume per void (MVV); and the OAB questionnaire (OAB‐q), Patient Perception of Bladder Condition (PPBC), and Urgency Perception Scale (UPS). Safety and tolerability were assessed and summarized over the 12‐week study period.
RESULTS
Fesoterodine (636 patients) significantly improved UUI episodes at week 12 (primary endpoint) compared with tolterodine ER (641 patients; P = 0.017) and placebo (313 patients; P |
| doi_str_mv | 10.1111/j.1464-410X.2009.09086.x |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_734275853</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>734275853</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4346-bad21c7a30fc52f0304fffb6f8d0f57d8ef178b1baf06b01f8944dd60fd3315a3</originalsourceid><addsrcrecordid>eNqNUctOHDEQtKKg8Eh-IfKN0w7tseexkTgkKwJBSFxAys3qGbfFrDzjje2F5ZZPQHxivoQZFvacPriru6vLUhdjXEAmxjhZZkKVaqYE_M5ygHkGc6jLbPOBHewGH98xzMt9dhjjEmBslMUntp-DkLkAecCeF75fYeiiH7i33FL0iYI33UAcB8OTd7uaNokGQ4YHcoSRuPWBpzviKRCmnoY0Sfh7Ctim7p5449AYCt848jtC8-_vU_LjM2G-cthSM5WtH1Lwzo3CKXToPrM9iy7Sl7d8xG5_nt0sLmZX1-e_Ft-vZq2Sqpw1aHLRVijBtkVuQYKy1jalrQ3YojI1WVHVjWjQQtmAsPVcKWNKsEZKUaA8Ysdb3VXwf9YUk-672JJzOJBfR11JlVdFXciRWW-ZbfAxBrJ6Fboew6MWoCdD9FJPt9bT3fVkiH41RG_G1a9vn6ybnsxu8d2BkXC6JTx0jh7_W1j_uLydkHwB6meg4w</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>734275853</pqid></control><display><type>article</type><title>Comparison of fesoterodine and tolterodine extended release for the treatment of overactive bladder: a head‐to‐head placebo‐controlled trial</title><source>MEDLINE</source><source>Wiley Journals</source><creator>Herschorn, Sender ; Swift, Steven ; Guan, Zhonghong ; Carlsson, Martin ; Morrow, Jon D. ; Brodsky, Marina ; Gong, Jason</creator><creatorcontrib>Herschorn, Sender ; Swift, Steven ; Guan, Zhonghong ; Carlsson, Martin ; Morrow, Jon D. ; Brodsky, Marina ; Gong, Jason</creatorcontrib><description><![CDATA[Study Type – Therapy (RCT)
Level of Evidence 1b
OBJECTIVE
To compare the efficacy and tolerability of fesoterodine 8 mg with tolterodine extended‐release (ER) 4 mg and placebo in a randomized clinical trial of patients with an overactive bladder (OAB).
PATIENTS AND METHODS
In this 12‐week double‐blind, double‐dummy, placebo‐controlled, randomized clinical trial, eligible patients reported OAB symptoms for ≥3 months and recorded ≥8 voids and ≥1 urgency urinary incontinence (UUI) episode per 24 h in 3‐day bladder diaries at baseline. Patients were randomized in a 2:2:1 ratio to fesoterodine (4 mg for 1 week then 8 mg for 11 weeks); tolterodine ER 4 mg; or placebo (with sham dose escalation for tolterodine ER and placebo). Endpoints were changes from baseline to week 12 in UUI episodes (primary endpoint), total and nocturnal voids, urgency episodes, severe urgency episodes, and frequency‐urgency sum per 24 h; mean voided volume per void (MVV); and the OAB questionnaire (OAB‐q), Patient Perception of Bladder Condition (PPBC), and Urgency Perception Scale (UPS). Safety and tolerability were assessed and summarized over the 12‐week study period.
RESULTS
Fesoterodine (636 patients) significantly improved UUI episodes at week 12 (primary endpoint) compared with tolterodine ER (641 patients; P = 0.017) and placebo (313 patients; P < 0.001). Fesoterodine also produced significantly greater improvements than tolterodine ER in MVV (P = 0.005). Fesoterodine significantly improved all diary endpoints compared with placebo (P < 0.001), except for nocturnal voids (P = 0.327). Tolterodine ER significantly improved all diary endpoints vs placebo (P < 0.001), except for nocturnal voids (P = 0.506) and MVV (P = 0.103). Diary dry rates (the proportion of patients reporting no UUI episodes at endpoint among those with one or more UUI episodes at baseline) were significantly higher with fesoterodine (64%) than with tolterodine ER (57%; P = 0.015) and placebo (45%; P < 0.001). Improvements in PPBC, UPS and OAB‐q scale and domain scores at week 12 were all significantly better with fesoterodine than placebo (all P < 0.001) and tolterodine ER (all P < 0.05) except for the OAB‐q Sleep domain vs tolterodine ER (P = 0.081). Dry mouth and constipation rates were 28% and 5% in the fesoterodine group, 16% and 4% in the tolterodine ER group, and 6% and 3% with placebo, respectively. Discontinuations due to treatment‐emergent adverse events were 6%, 4% and 2% in the fesoterodine, tolterodine ER, and placebo groups, respectively.
CONCLUSION
In patients with OAB, fesoterodine 8 mg showed superior efficacy over tolterodine ER 4 mg and placebo in reducing UUI episodes (primary endpoint) and in improving most patient‐reported outcome measures. Both active treatments were well tolerated.]]></description><identifier>ISSN: 1464-4096</identifier><identifier>EISSN: 1464-410X</identifier><identifier>DOI: 10.1111/j.1464-410X.2009.09086.x</identifier><identifier>PMID: 20132103</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>Adolescent ; Adult ; Aged ; Aged, 80 and over ; Benzhydryl Compounds - therapeutic use ; Cresols - therapeutic use ; Delayed-Action Preparations ; efficacy ; Epidemiologic Methods ; Female ; fesoterodine ; head‐to‐head ; Humans ; Male ; Middle Aged ; Muscarinic Antagonists - therapeutic use ; Patient Satisfaction ; patient‐reported outcomes ; Phenylpropanolamine - therapeutic use ; Quality of Life ; safety ; tolterodine ; Tolterodine Tartrate ; Treatment Outcome ; Urinary Bladder, Overactive - complications ; Urinary Bladder, Overactive - drug therapy ; Urinary Incontinence, Urge - drug therapy ; Urinary Incontinence, Urge - etiology ; Young Adult</subject><ispartof>BJU international, 2010-01, Vol.105 (1), p.58-66</ispartof><rights>2009 THE AUTHORS. JOURNAL COMPILATION © 2009 BJU INTERNATIONAL</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4346-bad21c7a30fc52f0304fffb6f8d0f57d8ef178b1baf06b01f8944dd60fd3315a3</citedby><cites>FETCH-LOGICAL-c4346-bad21c7a30fc52f0304fffb6f8d0f57d8ef178b1baf06b01f8944dd60fd3315a3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fj.1464-410X.2009.09086.x$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fj.1464-410X.2009.09086.x$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20132103$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Herschorn, Sender</creatorcontrib><creatorcontrib>Swift, Steven</creatorcontrib><creatorcontrib>Guan, Zhonghong</creatorcontrib><creatorcontrib>Carlsson, Martin</creatorcontrib><creatorcontrib>Morrow, Jon D.</creatorcontrib><creatorcontrib>Brodsky, Marina</creatorcontrib><creatorcontrib>Gong, Jason</creatorcontrib><title>Comparison of fesoterodine and tolterodine extended release for the treatment of overactive bladder: a head‐to‐head placebo‐controlled trial</title><title>BJU international</title><addtitle>BJU Int</addtitle><description><![CDATA[Study Type – Therapy (RCT)
Level of Evidence 1b
OBJECTIVE
To compare the efficacy and tolerability of fesoterodine 8 mg with tolterodine extended‐release (ER) 4 mg and placebo in a randomized clinical trial of patients with an overactive bladder (OAB).
PATIENTS AND METHODS
In this 12‐week double‐blind, double‐dummy, placebo‐controlled, randomized clinical trial, eligible patients reported OAB symptoms for ≥3 months and recorded ≥8 voids and ≥1 urgency urinary incontinence (UUI) episode per 24 h in 3‐day bladder diaries at baseline. Patients were randomized in a 2:2:1 ratio to fesoterodine (4 mg for 1 week then 8 mg for 11 weeks); tolterodine ER 4 mg; or placebo (with sham dose escalation for tolterodine ER and placebo). Endpoints were changes from baseline to week 12 in UUI episodes (primary endpoint), total and nocturnal voids, urgency episodes, severe urgency episodes, and frequency‐urgency sum per 24 h; mean voided volume per void (MVV); and the OAB questionnaire (OAB‐q), Patient Perception of Bladder Condition (PPBC), and Urgency Perception Scale (UPS). Safety and tolerability were assessed and summarized over the 12‐week study period.
RESULTS
Fesoterodine (636 patients) significantly improved UUI episodes at week 12 (primary endpoint) compared with tolterodine ER (641 patients; P = 0.017) and placebo (313 patients; P < 0.001). Fesoterodine also produced significantly greater improvements than tolterodine ER in MVV (P = 0.005). Fesoterodine significantly improved all diary endpoints compared with placebo (P < 0.001), except for nocturnal voids (P = 0.327). Tolterodine ER significantly improved all diary endpoints vs placebo (P < 0.001), except for nocturnal voids (P = 0.506) and MVV (P = 0.103). Diary dry rates (the proportion of patients reporting no UUI episodes at endpoint among those with one or more UUI episodes at baseline) were significantly higher with fesoterodine (64%) than with tolterodine ER (57%; P = 0.015) and placebo (45%; P < 0.001). Improvements in PPBC, UPS and OAB‐q scale and domain scores at week 12 were all significantly better with fesoterodine than placebo (all P < 0.001) and tolterodine ER (all P < 0.05) except for the OAB‐q Sleep domain vs tolterodine ER (P = 0.081). Dry mouth and constipation rates were 28% and 5% in the fesoterodine group, 16% and 4% in the tolterodine ER group, and 6% and 3% with placebo, respectively. Discontinuations due to treatment‐emergent adverse events were 6%, 4% and 2% in the fesoterodine, tolterodine ER, and placebo groups, respectively.
CONCLUSION
In patients with OAB, fesoterodine 8 mg showed superior efficacy over tolterodine ER 4 mg and placebo in reducing UUI episodes (primary endpoint) and in improving most patient‐reported outcome measures. Both active treatments were well tolerated.]]></description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Benzhydryl Compounds - therapeutic use</subject><subject>Cresols - therapeutic use</subject><subject>Delayed-Action Preparations</subject><subject>efficacy</subject><subject>Epidemiologic Methods</subject><subject>Female</subject><subject>fesoterodine</subject><subject>head‐to‐head</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Muscarinic Antagonists - therapeutic use</subject><subject>Patient Satisfaction</subject><subject>patient‐reported outcomes</subject><subject>Phenylpropanolamine - therapeutic use</subject><subject>Quality of Life</subject><subject>safety</subject><subject>tolterodine</subject><subject>Tolterodine Tartrate</subject><subject>Treatment Outcome</subject><subject>Urinary Bladder, Overactive - complications</subject><subject>Urinary Bladder, Overactive - drug therapy</subject><subject>Urinary Incontinence, Urge - drug therapy</subject><subject>Urinary Incontinence, Urge - etiology</subject><subject>Young Adult</subject><issn>1464-4096</issn><issn>1464-410X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNUctOHDEQtKKg8Eh-IfKN0w7tseexkTgkKwJBSFxAys3qGbfFrDzjje2F5ZZPQHxivoQZFvacPriru6vLUhdjXEAmxjhZZkKVaqYE_M5ygHkGc6jLbPOBHewGH98xzMt9dhjjEmBslMUntp-DkLkAecCeF75fYeiiH7i33FL0iYI33UAcB8OTd7uaNokGQ4YHcoSRuPWBpzviKRCmnoY0Sfh7Ctim7p5449AYCt848jtC8-_vU_LjM2G-cthSM5WtH1Lwzo3CKXToPrM9iy7Sl7d8xG5_nt0sLmZX1-e_Ft-vZq2Sqpw1aHLRVijBtkVuQYKy1jalrQ3YojI1WVHVjWjQQtmAsPVcKWNKsEZKUaA8Ysdb3VXwf9YUk-672JJzOJBfR11JlVdFXciRWW-ZbfAxBrJ6Fboew6MWoCdD9FJPt9bT3fVkiH41RG_G1a9vn6ybnsxu8d2BkXC6JTx0jh7_W1j_uLydkHwB6meg4w</recordid><startdate>201001</startdate><enddate>201001</enddate><creator>Herschorn, Sender</creator><creator>Swift, Steven</creator><creator>Guan, Zhonghong</creator><creator>Carlsson, Martin</creator><creator>Morrow, Jon D.</creator><creator>Brodsky, Marina</creator><creator>Gong, Jason</creator><general>Blackwell Publishing Ltd</general><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>7X8</scope></search><sort><creationdate>201001</creationdate><title>Comparison of fesoterodine and tolterodine extended release for the treatment of overactive bladder: a head‐to‐head placebo‐controlled trial</title><author>Herschorn, Sender ; Swift, Steven ; Guan, Zhonghong ; Carlsson, Martin ; Morrow, Jon D. ; Brodsky, Marina ; Gong, Jason</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4346-bad21c7a30fc52f0304fffb6f8d0f57d8ef178b1baf06b01f8944dd60fd3315a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Benzhydryl Compounds - therapeutic use</topic><topic>Cresols - therapeutic use</topic><topic>Delayed-Action Preparations</topic><topic>efficacy</topic><topic>Epidemiologic Methods</topic><topic>Female</topic><topic>fesoterodine</topic><topic>head‐to‐head</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Muscarinic Antagonists - therapeutic use</topic><topic>Patient Satisfaction</topic><topic>patient‐reported outcomes</topic><topic>Phenylpropanolamine - therapeutic use</topic><topic>Quality of Life</topic><topic>safety</topic><topic>tolterodine</topic><topic>Tolterodine Tartrate</topic><topic>Treatment Outcome</topic><topic>Urinary Bladder, Overactive - complications</topic><topic>Urinary Bladder, Overactive - drug therapy</topic><topic>Urinary Incontinence, Urge - drug therapy</topic><topic>Urinary Incontinence, Urge - etiology</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Herschorn, Sender</creatorcontrib><creatorcontrib>Swift, Steven</creatorcontrib><creatorcontrib>Guan, Zhonghong</creatorcontrib><creatorcontrib>Carlsson, Martin</creatorcontrib><creatorcontrib>Morrow, Jon D.</creatorcontrib><creatorcontrib>Brodsky, Marina</creatorcontrib><creatorcontrib>Gong, Jason</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>BJU international</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Herschorn, Sender</au><au>Swift, Steven</au><au>Guan, Zhonghong</au><au>Carlsson, Martin</au><au>Morrow, Jon D.</au><au>Brodsky, Marina</au><au>Gong, Jason</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Comparison of fesoterodine and tolterodine extended release for the treatment of overactive bladder: a head‐to‐head placebo‐controlled trial</atitle><jtitle>BJU international</jtitle><addtitle>BJU Int</addtitle><date>2010-01</date><risdate>2010</risdate><volume>105</volume><issue>1</issue><spage>58</spage><epage>66</epage><pages>58-66</pages><issn>1464-4096</issn><eissn>1464-410X</eissn><abstract><![CDATA[Study Type – Therapy (RCT)
Level of Evidence 1b
OBJECTIVE
To compare the efficacy and tolerability of fesoterodine 8 mg with tolterodine extended‐release (ER) 4 mg and placebo in a randomized clinical trial of patients with an overactive bladder (OAB).
PATIENTS AND METHODS
In this 12‐week double‐blind, double‐dummy, placebo‐controlled, randomized clinical trial, eligible patients reported OAB symptoms for ≥3 months and recorded ≥8 voids and ≥1 urgency urinary incontinence (UUI) episode per 24 h in 3‐day bladder diaries at baseline. Patients were randomized in a 2:2:1 ratio to fesoterodine (4 mg for 1 week then 8 mg for 11 weeks); tolterodine ER 4 mg; or placebo (with sham dose escalation for tolterodine ER and placebo). Endpoints were changes from baseline to week 12 in UUI episodes (primary endpoint), total and nocturnal voids, urgency episodes, severe urgency episodes, and frequency‐urgency sum per 24 h; mean voided volume per void (MVV); and the OAB questionnaire (OAB‐q), Patient Perception of Bladder Condition (PPBC), and Urgency Perception Scale (UPS). Safety and tolerability were assessed and summarized over the 12‐week study period.
RESULTS
Fesoterodine (636 patients) significantly improved UUI episodes at week 12 (primary endpoint) compared with tolterodine ER (641 patients; P = 0.017) and placebo (313 patients; P < 0.001). Fesoterodine also produced significantly greater improvements than tolterodine ER in MVV (P = 0.005). Fesoterodine significantly improved all diary endpoints compared with placebo (P < 0.001), except for nocturnal voids (P = 0.327). Tolterodine ER significantly improved all diary endpoints vs placebo (P < 0.001), except for nocturnal voids (P = 0.506) and MVV (P = 0.103). Diary dry rates (the proportion of patients reporting no UUI episodes at endpoint among those with one or more UUI episodes at baseline) were significantly higher with fesoterodine (64%) than with tolterodine ER (57%; P = 0.015) and placebo (45%; P < 0.001). Improvements in PPBC, UPS and OAB‐q scale and domain scores at week 12 were all significantly better with fesoterodine than placebo (all P < 0.001) and tolterodine ER (all P < 0.05) except for the OAB‐q Sleep domain vs tolterodine ER (P = 0.081). Dry mouth and constipation rates were 28% and 5% in the fesoterodine group, 16% and 4% in the tolterodine ER group, and 6% and 3% with placebo, respectively. Discontinuations due to treatment‐emergent adverse events were 6%, 4% and 2% in the fesoterodine, tolterodine ER, and placebo groups, respectively.
CONCLUSION
In patients with OAB, fesoterodine 8 mg showed superior efficacy over tolterodine ER 4 mg and placebo in reducing UUI episodes (primary endpoint) and in improving most patient‐reported outcome measures. Both active treatments were well tolerated.]]></abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>20132103</pmid><doi>10.1111/j.1464-410X.2009.09086.x</doi><tpages>9</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1464-4096 |
| ispartof | BJU international, 2010-01, Vol.105 (1), p.58-66 |
| issn | 1464-4096 1464-410X |
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| subjects | Adolescent Adult Aged Aged, 80 and over Benzhydryl Compounds - therapeutic use Cresols - therapeutic use Delayed-Action Preparations efficacy Epidemiologic Methods Female fesoterodine head‐to‐head Humans Male Middle Aged Muscarinic Antagonists - therapeutic use Patient Satisfaction patient‐reported outcomes Phenylpropanolamine - therapeutic use Quality of Life safety tolterodine Tolterodine Tartrate Treatment Outcome Urinary Bladder, Overactive - complications Urinary Bladder, Overactive - drug therapy Urinary Incontinence, Urge - drug therapy Urinary Incontinence, Urge - etiology Young Adult |
| title | Comparison of fesoterodine and tolterodine extended release for the treatment of overactive bladder: a head‐to‐head placebo‐controlled trial |
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