User menu

Accès à distance ? S'identifier sur le proxy UCLouvain

Solifenacin in the treatment of urgency and other symptoms of overactive bladder: results from a randomized, double-blind, placebo-controlled, rising-dose trial

Primary tabs

download
  • Open access
  • PDF
  • 351.14 K
Cardozo, Linda Hessdörfer, Elke Milani, Rodolfo Arano, Pedro Dewilde, Luc for the SUNRISE Study Group (D. De Ridder, R. Opsomer et al.) [UCL]

OBJECTIVES: To examine the effects of the antimuscarinic agent solifenacin on urinary urgency, using a range of novel and established outcome measures, as urgency is the principal symptom of the overactive bladder syndrome (OAB). PATIENTS AND METHODS: The study (SUNRISE, solifenacin in the treatment of urgency symptoms of OAB in a rising dose, randomized, placebo-controlled, double-blind, efficacy trial) was a randomized, double-blind, 16-week, placebo-controlled, multicentre study of solifenacin 5/10 mg in 863 patients with symptoms of OAB for > or = 3 months. The primary efficacy variable was the change from baseline to endpoint in the number of episodes of severe urgency with or without urgency incontinence per 24 h, as measured using the Patient Perception of Intensity of Urgency Scale, grade 3 + 4. Secondary efficacy variables included patient-reported outcomes for bladder condition, urgency bother and treatment satisfaction. A 3-day voiding diary was used to record micturition frequency and episodes of urgency and incontinence. A 7-day diary was used to assess speed of onset of effect. RESULTS: Solifenacin 5/10 mg was significantly more effective than placebo in reducing the mean number of episodes of severe urgency with or without incontinence per 24 h from baseline to endpoint (-2.6 vs -1.8, P < 0.001). There were also statistically significant differences in favour of solifenacin 5/10 mg over placebo for all secondary variables measured at endpoint, including patient-reported outcomes. There was a significant improvement in urgency as early as day 3 of treatment. Treatmente-mergent adverse events with solifenacin 5/10 mg were mainly mild or moderate in severity, and only led to discontinuation in 3.6% of patients. CONCLUSION: Solifenacin significantly reduced the number of urgency episodes and the extent of urgency bother, and was well tolerated; it was effective as early as day 3 of treatment.

Document type Article de périodique (Journal article) – Article de recherche
Access type Accès libre
Publication date 2008
Language Anglais
Journal information "BJU international" - Vol. 102, no. 9, p. 1120-7 (2008)
Publisher Blackwell Science Ltd ((United Kingdom) Oxford)
issn 1464-4096
e-issn 1464-410X
Publication status Publié
Affiliations UCL - (SLuc) Service d'urologie
UCL - (SLuc) Centre de pathologie sexuelle masculine
UCL - MD/CHIR - Département de chirurgie
MESH Subject Dose-Response Relationship, Drug ; Tetrahydroisoquinolines ; Treatment Outcome ; Urinary Bladder, Overactive ; Urination Disorders ; Urodynamics ; Double-Blind Method ; Female ; Humans ; Male ; Middle Aged ; Muscarinic Antagonists ; Quinuclidines ; Severity of Illness Index
Keywords Solifenacin ; Urgency ; Incontinence ; Overactive bladder ; PPIUS
Links
  1. Irwin, Eur Urol, 50, 1306 (2006)
  2. Milsom, BJU Int, 87, 760 (2001)
  3. Stewart, World J Urol, 20, 327 (2003)
  4. Abrams, Neurourol Urodyn, 21, 167 (2002)
  5. Abrams, Neurourol Urodyn, 25, 293 (2006)
  6. Chapple, BJU Int, 95, 335 (2005)
  7. Payne, BJU Int, 99, 101 (2007)
  8. Chapple, Int J Clin Pract, 60, 959 (2006)
  9. Chapple C.R., Martinez-Garcia R., Selvaggi L., Toozs-Hobson P., Warnack W., Drogendijk T., Wright D.M., Bolodeoku J., A Comparison of the Efficacy and Tolerability of Solifenacin Succinate and Extended Release Tolterodine at Treating Overactive Bladder Syndrome: Results of the STAR Trial, 10.1016/j.eururo.2005.05.015
  10. Michel, BJU Int, 96, 37 (2005)
  11. Committee for Proprietary Medicinal Products., Note for Guidance on the Clinical Investigation of Medicinal Products for the Treatment of Urinary Incontinence. CPMP/EWP/18/01. (2002)
  12. Michel, Urology, 68, 71 (2008)
  13. Artibani, Eur Urol Suppl, 6, 17 (2007)
  14. Schagen van Leeuwen, Eur Urol, 50, 440 (2006)
Bibliographic reference Cardozo, Linda ; Hessdörfer, Elke ; Milani, Rodolfo ; Arano, Pedro ; Dewilde, Luc ; et. al. Solifenacin in the treatment of urgency and other symptoms of overactive bladder: results from a randomized, double-blind, placebo-controlled, rising-dose trial. In: BJU international, Vol. 102, no. 9, p. 1120-7 (2008)
Permanent URL http://hdl.handle.net/2078.1/120411