Skip to main content
Erschienen in: International Urogynecology Journal 7/2010

01.07.2010 | Original Article

Solifenacin for overactive bladder: secondary analysis of data from VENUS based on baseline continence status

verfasst von: Marc R. Toglia, Donald R. Ostergard, Rodney A. Appell, Masakazu Andoh, Allam Fakhoury, Iqbal F. Hussain

Erschienen in: International Urogynecology Journal | Ausgabe 7/2010

Einloggen, um Zugang zu erhalten

Abstract

Introduction and hypothesis

VENUS evaluated the efficacy of solifenacin on urgency in patients with overactive bladder (OAB). We hypothesized that solifenacin would be comparably efficacious in continent and incontinent patients.

Methods

VENUS was a 12-week, placebo-controlled trial in patients with OAB. Treatment efficacy was assessed using bladder diaries and patient-reported outcome measures. The primary endpoint was the change in daily urgency episodes. Exploratory subgroup analyses were conducted using baseline continence status.

Results

Solifenacin reduced urgency episodes versus placebo in continent (−3.4 vs. −2.3) and incontinent patients (−4.2 vs. −2.9) and incontinence episodes (−2.1 vs. −1.2) in that subgroup; 58% versus 42% of incontinent patients receiving solifenacin versus placebo were continent at study end. In both cohorts, solifenacin- versus placebo-treated patients showed greater improvements in perceptions of urgency severity, symptom bother, and health-related quality of life.

Conclusion

This post hoc analysis demonstrates the efficacy of solifenacin regardless of baseline continence status.
Literatur
1.
Zurück zum Zitat Abrams P, Artibani W, Cardozo L, Dmochowski R, van Kerrebroeck P, Sand P (2006) Reviewing the ICS 2002 terminology report: the ongoing debate. Neurourol Urodyn 25:293CrossRef Abrams P, Artibani W, Cardozo L, Dmochowski R, van Kerrebroeck P, Sand P (2006) Reviewing the ICS 2002 terminology report: the ongoing debate. Neurourol Urodyn 25:293CrossRef
2.
Zurück zum Zitat Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U et al (2002) The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn 21:167–178CrossRefPubMed Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U et al (2002) The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn 21:167–178CrossRefPubMed
3.
Zurück zum Zitat Chapple CR, Artibani W, Cardozo LD, Castro-Diaz D, Craggs M, Haab F et al (2005) The role of urinary urgency and its measurement in the overactive bladder symptom syndrome: current concepts and future prospects. BJU Int 95:335–340CrossRefPubMed Chapple CR, Artibani W, Cardozo LD, Castro-Diaz D, Craggs M, Haab F et al (2005) The role of urinary urgency and its measurement in the overactive bladder symptom syndrome: current concepts and future prospects. BJU Int 95:335–340CrossRefPubMed
4.
Zurück zum Zitat Irwin DE, Milsom I, Hunskaar S, Reilly K, Kopp Z, Herschorn S et al (2006) Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol 50:1306–1315CrossRefPubMed Irwin DE, Milsom I, Hunskaar S, Reilly K, Kopp Z, Herschorn S et al (2006) Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol 50:1306–1315CrossRefPubMed
5.
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
6.
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
7.
Zurück zum Zitat Chapple CR, Khullar V, Gabriel Z, Muston D, Bitoun CE, Weinstein D (2008) The effects of antimuscarinic treatments in overactive bladder: an update of a systematic review and meta-analysis. Eur Urol 54:543–562CrossRefPubMed Chapple CR, Khullar V, Gabriel Z, Muston D, Bitoun CE, Weinstein D (2008) The effects of antimuscarinic treatments in overactive bladder: an update of a systematic review and meta-analysis. Eur Urol 54:543–562CrossRefPubMed
8.
Zurück zum Zitat Abrams P, Swift S (2005) Solifenacin is effective for the treatment of OAB dry patients: a pooled analysis. Eur Urol 48:483–487PubMed Abrams P, Swift S (2005) Solifenacin is effective for the treatment of OAB dry patients: a pooled analysis. Eur Urol 48:483–487PubMed
9.
Zurück zum Zitat Nitti VW, Dmochowski R, Appell RA, Wang JT, Bavendam T, Guan Z (2006) Efficacy and tolerability of tolterodine extended-release in continent patients with overactive bladder and nocturia. BJU Int 97:1262–1266CrossRefPubMed Nitti VW, Dmochowski R, Appell RA, Wang JT, Bavendam T, Guan Z (2006) Efficacy and tolerability of tolterodine extended-release in continent patients with overactive bladder and nocturia. BJU Int 97:1262–1266CrossRefPubMed
10.
Zurück zum Zitat Michel MC, de la Rosette JJ, Piro M, Schneider T (2005) Comparison of symptom severity and treatment response in patients with incontinent and continent overactive bladder. Eur Urol 48:110–115CrossRefPubMed Michel MC, de la Rosette JJ, Piro M, Schneider T (2005) Comparison of symptom severity and treatment response in patients with incontinent and continent overactive bladder. Eur Urol 48:110–115CrossRefPubMed
11.
Zurück zum Zitat Rovner ES, Rackley R, Nitti VW, Wang JT, Guan Z, 037 Study Group (2008) Tolterodine extended release is efficacious in continent and incontinent subjects with overactive bladder. Urology 72:488–493CrossRefPubMed Rovner ES, Rackley R, Nitti VW, Wang JT, Guan Z, 037 Study Group (2008) Tolterodine extended release is efficacious in continent and incontinent subjects with overactive bladder. Urology 72:488–493CrossRefPubMed
12.
Zurück zum Zitat Cardozo L, Lisec M, Millard R, van Vierssen TO, Kuzmin I, Drogendijk TE et al (2004) Randomized, double-blind placebo controlled trial of the once daily antimuscarinic agent solifenacin succinate in patients with overactive bladder. J Urol 172:1919–1924CrossRefPubMed Cardozo L, Lisec M, Millard R, van Vierssen TO, Kuzmin I, Drogendijk TE et al (2004) Randomized, double-blind placebo controlled trial of the once daily antimuscarinic agent solifenacin succinate in patients with overactive bladder. J Urol 172:1919–1924CrossRefPubMed
13.
Zurück zum Zitat Chapple CR, Rechberger T, Al-Shukri S, Meffan P, Everaert K, Huang M et al (2004) Randomized, double-blind placebo- and tolterodine-controlled trial of the once-daily antimuscarinic agent solifenacin in patients with symptomatic overactive bladder. BJU Int 93:303–310CrossRefPubMed Chapple CR, Rechberger T, Al-Shukri S, Meffan P, Everaert K, Huang M et al (2004) Randomized, double-blind placebo- and tolterodine-controlled trial of the once-daily antimuscarinic agent solifenacin in patients with symptomatic overactive bladder. BJU Int 93:303–310CrossRefPubMed
14.
Zurück zum Zitat Gittelman M, Chu FM, Klimberg I, Fincher R, Smith N, Tempel D et al (2003) Two randomized, double-blind, placebo-controlled, parallel-group, fixed-dose, multi-center studies assess the efficacy and safety of daily oral administration of 10 mg YM905 versus placebo in male and female subjects with overactive bladder [abstract DP43]. J Urol 169:349 Gittelman M, Chu FM, Klimberg I, Fincher R, Smith N, Tempel D et al (2003) Two randomized, double-blind, placebo-controlled, parallel-group, fixed-dose, multi-center studies assess the efficacy and safety of daily oral administration of 10 mg YM905 versus placebo in male and female subjects with overactive bladder [abstract DP43]. J Urol 169:349
15.
Zurück zum Zitat Karram MM, Toglia MR, Serels SR, Andoh M, Fakhoury A, Forero-Schwanhaeuser S (2009) Treatment with solifenacin increases warning time and improves symptoms of overactive bladder: results from VENUS, a randomized, double-blind, placebo-controlled trial. Urology 73:14–18CrossRefPubMed Karram MM, Toglia MR, Serels SR, Andoh M, Fakhoury A, Forero-Schwanhaeuser S (2009) Treatment with solifenacin increases warning time and improves symptoms of overactive bladder: results from VENUS, a randomized, double-blind, placebo-controlled trial. Urology 73:14–18CrossRefPubMed
16.
Zurück zum Zitat Toglia MR, Serels SR, Laramee C, Karram MM, Nandy IM, Andoh M et al (2009) Solifenacin for overactive bladder: patient-reported outcomes from a large placebo-controlled trial. Postgrad Med 121:151–158CrossRefPubMed Toglia MR, Serels SR, Laramee C, Karram MM, Nandy IM, Andoh M et al (2009) Solifenacin for overactive bladder: patient-reported outcomes from a large placebo-controlled trial. Postgrad Med 121:151–158CrossRefPubMed
17.
Zurück zum Zitat Cardozo L, Dixon A (2005) Increased warning time with darifenacin: a new concept in the management of urinary urgency. J Urol 173:1214–1218CrossRefPubMed Cardozo L, Dixon A (2005) Increased warning time with darifenacin: a new concept in the management of urinary urgency. J Urol 173:1214–1218CrossRefPubMed
18.
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
19.
Zurück zum Zitat Cardozo L, Coyne KS, Versi E (2005) Validation of the urgency perception scale. BJU Int 95:591–596CrossRefPubMed Cardozo L, Coyne KS, Versi E (2005) Validation of the urgency perception scale. BJU Int 95:591–596CrossRefPubMed
20.
Zurück zum Zitat Coyne KS, Matza LS, Kopp Z, Abrams P (2006) The validation of the patient perception of bladder condition (PPBC): a single-item global measure for patients with overactive bladder. Eur Urol 49:1079–1086CrossRefPubMed Coyne KS, Matza LS, Kopp Z, Abrams P (2006) The validation of the patient perception of bladder condition (PPBC): a single-item global measure for patients with overactive bladder. Eur Urol 49:1079–1086CrossRefPubMed
21.
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
22.
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
23.
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 50:440–452, discussion 453CrossRefPubMed 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 50:440–452, discussion 453CrossRefPubMed
Metadaten
Titel
Solifenacin for overactive bladder: secondary analysis of data from VENUS based on baseline continence status
verfasst von
Marc R. Toglia
Donald R. Ostergard
Rodney A. Appell
Masakazu Andoh
Allam Fakhoury
Iqbal F. Hussain
Publikationsdatum
01.07.2010
Verlag
Springer-Verlag
Erschienen in
International Urogynecology Journal / Ausgabe 7/2010
Print ISSN: 0937-3462
Elektronische ISSN: 1433-3023
DOI
https://doi.org/10.1007/s00192-010-1120-6

Weitere Artikel der Ausgabe 7/2010

International Urogynecology Journal 7/2010 Zur Ausgabe

Update Gynäkologie

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