Skip to main content
Erschienen in: International Urogynecology Journal 12/2009

01.12.2009 | Original Article

Trospium chloride extended release is effective and well tolerated in women with overactive bladder syndrome

verfasst von: Peter K. Sand, Roger R. Dmochowski, Norman R. Zinner, David R. Staskin, Rodney A. Appell

Erschienen in: International Urogynecology Journal | Ausgabe 12/2009

Einloggen, um Zugang zu erhalten

Abstract

Introduction and hypothesis

To confirm the efficacy and tolerability of extended release (ER) trospium chloride in women with overactive bladder syndrome (OAB), data from two identical phase III studies were analyzed.

Methods

Adults (aged ≥ 18 years) who had OAB with urinary urgency, frequency, and urge urinary incontinence (UUI) were randomized to trospium ER 60 mg or placebo once daily for 12 weeks. The analysis included 989 women (trospium ER, n = 484; placebo, n = 505). Endpoints examined included changes from baseline in number of toilet voids and UUI episodes/day at week 12. Continuous data were analyzed using rank analysis of variance.

Results

At week 12, significantly greater mean reductions in numbers of toilet voids and UUI episodes/day occurred with trospium ER versus placebo (P < 0.0001). Adverse events considered at least possibly related to treatment with trospium ER included dry mouth (11.4%) and constipation (8.9%).

Conclusions

Trospium ER was effective and well tolerated in women with OAB.
Literatur
1.
Zurück zum Zitat Stewart WF, Van Rooyen JB, Cundiff GW, Abrams P, Herzog AR, Corey R et al (2003) Prevalence and burden of overactive bladder in the United States. World J Urol 20:327–336PubMed Stewart WF, Van Rooyen JB, Cundiff GW, Abrams P, Herzog AR, Corey R et al (2003) Prevalence and burden of overactive bladder in the United States. World J Urol 20:327–336PubMed
2.
Zurück zum Zitat Dmochowski RR, Newman DK (2007) Impact of overactive bladder on women in the United States: results of a national survey. Curr Med Res Opin 23:65–76CrossRefPubMed Dmochowski RR, Newman DK (2007) Impact of overactive bladder on women in the United States: results of a national survey. Curr Med Res Opin 23:65–76CrossRefPubMed
3.
Zurück zum Zitat Milsom I, Abrams P, Cardozo L, Roberts RG, Thuroff J, Wein AJ (2001) How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study. BJU Int 87:760–766CrossRefPubMed Milsom I, Abrams P, Cardozo L, Roberts RG, Thuroff J, Wein AJ (2001) How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study. BJU Int 87:760–766CrossRefPubMed
4.
Zurück zum Zitat Campbell UB, Stang P, Barron R (2007) Survey assessment of continuation of and satisfaction with pharmacological treatment for urinary incontinence. Value Health 11:726–732CrossRefPubMed Campbell UB, Stang P, Barron R (2007) Survey assessment of continuation of and satisfaction with pharmacological treatment for urinary incontinence. Value Health 11:726–732CrossRefPubMed
5.
Zurück zum Zitat Dmochowski RR, Sand PK, Zinner NR, Staskin DR (2008) Trospium 60 mg once daily (QD) for overactive bladder syndrome: results from a placebo-controlled interventional study. Urology 71:449–454CrossRefPubMed Dmochowski RR, Sand PK, Zinner NR, Staskin DR (2008) Trospium 60 mg once daily (QD) for overactive bladder syndrome: results from a placebo-controlled interventional study. Urology 71:449–454CrossRefPubMed
6.
Zurück zum Zitat Staskin D, Sand P, Zinner N, Dmochowski R (2007) Once daily trospium chloride is effective and well tolerated for the treatment of overactive bladder: results from a multicenter phase III trial. J Urol 178:978–983CrossRefPubMed Staskin D, Sand P, Zinner N, Dmochowski R (2007) Once daily trospium chloride is effective and well tolerated for the treatment of overactive bladder: results from a multicenter phase III trial. J Urol 178:978–983CrossRefPubMed
7.
Zurück zum Zitat Nixon A, Colman S, Sabounjian L, Sandage B, Schwiderski UE, Staskin DR et al (2005) A validated patient reported measure of urinary urgency severity in overactive bladder for use in clinical trials. J Urol 174:604–607CrossRefPubMed Nixon A, Colman S, Sabounjian L, Sandage B, Schwiderski UE, Staskin DR et al (2005) A validated patient reported measure of urinary urgency severity in overactive bladder for use in clinical trials. J Urol 174:604–607CrossRefPubMed
8.
Zurück zum Zitat Zinner N, Harnett M, Sabounjian L, Sandage B Jr, Dmochowski R, Staskin D (2005) The overactive bladder-symptom composite score: a composite symptom score of toilet voids, urgency severity and urge urinary incontinence in patients with overactive bladder. J Urol 173:1639–1643CrossRefPubMed Zinner N, Harnett M, Sabounjian L, Sandage B Jr, Dmochowski R, Staskin D (2005) The overactive bladder-symptom composite score: a composite symptom score of toilet voids, urgency severity and urge urinary incontinence in patients with overactive bladder. J Urol 173:1639–1643CrossRefPubMed
9.
Zurück zum Zitat Kelleher CJ, Cardozo LD, Khullar V, Salvatore S (1997) A new questionnaire to assess the quality of life of urinary incontinent women. Br J Obstet Gynaecol 104:1374–1379PubMed Kelleher CJ, Cardozo LD, Khullar V, Salvatore S (1997) A new questionnaire to assess the quality of life of urinary incontinent women. Br J Obstet Gynaecol 104:1374–1379PubMed
10.
Zurück zum Zitat Coyne K, Revicki D, Hunt T, Corey R, Stewart W, Bentkover J et al (2002) Psychometric validation of an overactive bladder symptom and health-related quality of life questionnaire: the OAB-q. Qual Life Res 11:563–574CrossRefPubMed Coyne K, Revicki D, Hunt T, Corey R, Stewart W, Bentkover J et al (2002) Psychometric validation of an overactive bladder symptom and health-related quality of life questionnaire: the OAB-q. Qual Life Res 11:563–574CrossRefPubMed
11.
Zurück zum Zitat Melville JL, Delaney K, Newton K, Katon W (2005) Incontinence severity and major depression in incontinent women. Obstet Gynecol 106:585–592PubMed Melville JL, Delaney K, Newton K, Katon W (2005) Incontinence severity and major depression in incontinent women. Obstet Gynecol 106:585–592PubMed
12.
Zurück zum Zitat Wilson L, Brown JS, Shin GP, Luc KO, Subak LL (2001) Annual direct cost of urinary incontinence. Obstet Gynecol 98:398–406CrossRefPubMed Wilson L, Brown JS, Shin GP, Luc KO, Subak LL (2001) Annual direct cost of urinary incontinence. Obstet Gynecol 98:398–406CrossRefPubMed
13.
Zurück zum Zitat Wein AJ, Khullar V, Wang JT, Guan Z (2007) Achieving continence with antimuscarinic therapy for overactive bladder: effects of baseline incontinence severity and bladder diary duration. BJU Int 99:360–363CrossRefPubMed Wein AJ, Khullar V, Wang JT, Guan Z (2007) Achieving continence with antimuscarinic therapy for overactive bladder: effects of baseline incontinence severity and bladder diary duration. BJU Int 99:360–363CrossRefPubMed
14.
Zurück zum Zitat Cardozo L, Castro-Diaz D, Gittelman M, Ridder A, Huang M (2006) Reductions in overactive bladder-related incontinence from pooled analysis of phase III trials evaluating treatment with solifenacin. Int Urogynecol J Pelvic Floor Dysfunct 17:512–519CrossRefPubMed Cardozo L, Castro-Diaz D, Gittelman M, Ridder A, Huang M (2006) Reductions in overactive bladder-related incontinence from pooled analysis of phase III trials evaluating treatment with solifenacin. Int Urogynecol J Pelvic Floor Dysfunct 17:512–519CrossRefPubMed
15.
Zurück zum Zitat Dmochowski RR, Sand PK, Zinner NR, Gittelman MC, Davila GW, Sanders SW (2003) Comparative efficacy and safety of transdermal oxybutynin and oral tolterodine versus placebo in previously treated patients with urge and mixed urinary incontinence. Urology 62:237–242CrossRefPubMed Dmochowski RR, Sand PK, Zinner NR, Gittelman MC, Davila GW, Sanders SW (2003) Comparative efficacy and safety of transdermal oxybutynin and oral tolterodine versus placebo in previously treated patients with urge and mixed urinary incontinence. Urology 62:237–242CrossRefPubMed
16.
Zurück zum Zitat Kay G, Crook T, Rekeda L, Lima R, Ebinger U, Arguinzoniz M et al (2006) Differential effects of the antimuscarinic agents darifenacin and oxybutynin ER on memory in older subjects. Eur Urol 50:317–326CrossRefPubMed Kay G, Crook T, Rekeda L, Lima R, Ebinger U, Arguinzoniz M et al (2006) Differential effects of the antimuscarinic agents darifenacin and oxybutynin ER on memory in older subjects. Eur Urol 50:317–326CrossRefPubMed
17.
Zurück zum Zitat Staskin DR, Harnett MD (2004) Effect of trospium chloride on somnolence and sleepiness in patients with overactive bladder. Curr Urol Rep 5:423–426CrossRefPubMed Staskin DR, Harnett MD (2004) Effect of trospium chloride on somnolence and sleepiness in patients with overactive bladder. Curr Urol Rep 5:423–426CrossRefPubMed
18.
Zurück zum Zitat Diefenbach K, Arold G, Wollny A, Schwantes U, Haselmann J, Roots I (2005) Effects on sleep of anticholinergics used for overactive bladder treatment in healthy volunteers aged ≥50 years. BJU Int 95:346–349CrossRefPubMed Diefenbach K, Arold G, Wollny A, Schwantes U, Haselmann J, Roots I (2005) Effects on sleep of anticholinergics used for overactive bladder treatment in healthy volunteers aged ≥50 years. BJU Int 95:346–349CrossRefPubMed
19.
Zurück zum Zitat Todorova A, Vonderheid-Guth B, Dimpfel W (2001) Effects of tolterodine, trospium chloride, and oxybutynin on the central nervous system. J Clin Pharmacol 41:636–644CrossRefPubMed Todorova A, Vonderheid-Guth B, Dimpfel W (2001) Effects of tolterodine, trospium chloride, and oxybutynin on the central nervous system. J Clin Pharmacol 41:636–644CrossRefPubMed
20.
Zurück zum Zitat Kay G, Malhotra B, Michel MC (2009) Assessment of central nervous system access of a new antimuscarinic drug, fesoterodine. J Urol 181(Suppl.):84CrossRef Kay G, Malhotra B, Michel MC (2009) Assessment of central nervous system access of a new antimuscarinic drug, fesoterodine. J Urol 181(Suppl.):84CrossRef
21.
Zurück zum Zitat Sandage B, Lerch G, Larsen G, Profy A (2009) Trospium chloride does not cross the blood-brain barrier of male Long Evans rats. Neurology 72(Suppl 3):A50 Sandage B, Lerch G, Larsen G, Profy A (2009) Trospium chloride does not cross the blood-brain barrier of male Long Evans rats. Neurology 72(Suppl 3):A50
22.
Zurück zum Zitat Geyer J, Gavrilova O, Petzinger E (2009) The role of P-glycoprotein in limiting brain penetration of the peripherally acting anticholinergic OAB drug trospium chloride. Drug Metab Dispos 37(7):1371–1374CrossRefPubMed Geyer J, Gavrilova O, Petzinger E (2009) The role of P-glycoprotein in limiting brain penetration of the peripherally acting anticholinergic OAB drug trospium chloride. Drug Metab Dispos 37(7):1371–1374CrossRefPubMed
23.
Zurück zum Zitat Rudy D, Cline K, Harris R, Goldberg K, Dmochowski R (2006) Multicenter phase III trial studying trospium chloride in patients with overactive bladder. Urology 67:275–280CrossRefPubMed Rudy D, Cline K, Harris R, Goldberg K, Dmochowski R (2006) Multicenter phase III trial studying trospium chloride in patients with overactive bladder. Urology 67:275–280CrossRefPubMed
24.
Zurück zum Zitat Zinner N, Gittelman M, Harris R, Susset J, Kanelos A, Auerbach S (2004) Trospium chloride improves overactive bladder symptoms: a multicenter phase III trial. J Urol 171:2311–2315 quiz 2435CrossRefPubMed Zinner N, Gittelman M, Harris R, Susset J, Kanelos A, Auerbach S (2004) Trospium chloride improves overactive bladder symptoms: a multicenter phase III trial. J Urol 171:2311–2315 quiz 2435CrossRefPubMed
25.
Zurück zum Zitat Birns J, Lukkari E, Malone-Lee JG (2000) A randomized controlled trial comparing the efficacy of controlled-release oxybutynin tablets (10 mg once daily) with conventional oxybutynin tablets (5 mg twice daily) in patients whose symptoms were stabilized on 5 mg twice daily of oxybutynin. BJU Int 85:793–798CrossRefPubMed Birns J, Lukkari E, Malone-Lee JG (2000) A randomized controlled trial comparing the efficacy of controlled-release oxybutynin tablets (10 mg once daily) with conventional oxybutynin tablets (5 mg twice daily) in patients whose symptoms were stabilized on 5 mg twice daily of oxybutynin. BJU Int 85:793–798CrossRefPubMed
26.
Zurück zum Zitat Van Kerrebroeck P, Kreder K, Jonas U, Zinner N, Wein A (2001) Tolterodine once-daily: superior efficacy and tolerability in the treatment of the overactive bladder. Urology 57:414–421CrossRefPubMed Van Kerrebroeck P, Kreder K, Jonas U, Zinner N, Wein A (2001) Tolterodine once-daily: superior efficacy and tolerability in the treatment of the overactive bladder. Urology 57:414–421CrossRefPubMed
27.
Zurück zum Zitat Dmochowski R, Abrams P, Marschall-Kehrel D, Wang JT, Guan Z (2007) Efficacy and tolerability of tolterodine extended release in male and female patients with overactive bladder. Eur Urol 51:1054–1064CrossRefPubMed Dmochowski R, Abrams P, Marschall-Kehrel D, Wang JT, Guan Z (2007) Efficacy and tolerability of tolterodine extended release in male and female patients with overactive bladder. Eur Urol 51:1054–1064CrossRefPubMed
28.
Zurück zum Zitat Swift S, Garely A, Dimpfl T, Payne C (2003) A new once-daily formulation of tolterodine provides superior efficacy and is well tolerated in women with overactive bladder. Int Urogynecol J Pelvic Floor Dysfunct 14:50–54 discussion 54-55CrossRefPubMed Swift S, Garely A, Dimpfl T, Payne C (2003) A new once-daily formulation of tolterodine provides superior efficacy and is well tolerated in women with overactive bladder. Int Urogynecol J Pelvic Floor Dysfunct 14:50–54 discussion 54-55CrossRefPubMed
29.
Zurück zum Zitat van Leeuwen JH, Castro R, Busse M, Bemelmans BL (2006) The placebo effect in the pharmacologic treatment of patients with lower urinary tract symptoms. Eur Urol 50:440–452CrossRefPubMed van Leeuwen JH, Castro R, Busse M, Bemelmans BL (2006) The placebo effect in the pharmacologic treatment of patients with lower urinary tract symptoms. Eur Urol 50:440–452CrossRefPubMed
30.
Zurück zum Zitat Nabi G, Cody JD, Ellis G, Herbison P, Hay-Smith J (2006) Anticholinergic drugs versus placebo for overactive bladder syndrome in adults. Cochrane Database Syst Rev 4:CD003781 Nabi G, Cody JD, Ellis G, Herbison P, Hay-Smith J (2006) Anticholinergic drugs versus placebo for overactive bladder syndrome in adults. Cochrane Database Syst Rev 4:CD003781
Metadaten
Titel
Trospium chloride extended release is effective and well tolerated in women with overactive bladder syndrome
verfasst von
Peter K. Sand
Roger R. Dmochowski
Norman R. Zinner
David R. Staskin
Rodney A. Appell
Publikationsdatum
01.12.2009
Verlag
Springer-Verlag
Erschienen in
International Urogynecology Journal / Ausgabe 12/2009
Print ISSN: 0937-3462
Elektronische ISSN: 1433-3023
DOI
https://doi.org/10.1007/s00192-009-0969-8

Weitere Artikel der Ausgabe 12/2009

International Urogynecology Journal 12/2009 Zur Ausgabe

Update Gynäkologie

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert – ganz bequem per eMail.