Skip to main content

Advertisement

SpringerLink
Log in

Efficacy and tolerability of solifenacin in men with overactive bladder: results of an observational study

  • Original Article
  • Published:
World Journal of Urology Aims and scope Submit manuscript

Abstract

Purpose

To evaluate the efficacy and safety of solifenacin for the treatment of OAB in men.

Methods

This prospective observational study, reflective of actual practice patterns, was conducted in men older than 18 years who were prescribed solifenacin for the treatment of OAB symptoms. Men with suspected bladder outlet obstruction were excluded. The primary efficacy measure was change in OAB symptoms after 12 weeks of solifenacin. Also assessed were changes in severity of urinary urgency, IPSS, quality of life, cognitive function, and adverse events. Data were analyzed using descriptive methods.

Results

A total of 799 men recruited at 251 centers, average age 67 years (range 27–92), received solifenacin 5 mg or 10 mg/day. Mean episodes of urinary urgency, frequency, and nocturia decreased by 4.4, 3.6, and 1.4 episodes/24 h, respectively. As per IPSS, severe urinary symptoms were reported by 20.4 % at baseline versus by 2.3 % at week 12. Both voiding and storage symptoms showed improvement. Patient-reported general health condition was excellent/good for 39 % at baseline increasing to 76 % at week 12. Adverse event rate was 5.5 %, and discontinuation of solifenacin due to an event was 1.6 %. No change in post-void residual urine volume was experienced in 80%, while an increase of ≥50 mL was observed in 2.2 %; no cases of acute urinary retention occurred. Baseline mean MMSE was 27.5 points versus 27.9 points at week 12.

Conclusions

Solifenacin reduced all OAB symptoms, was well tolerated, and had no apparent effect on post-void residual urine volume. Cognitive function was unaltered in this population of older men with OAB.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2

Similar content being viewed by others

References

  1. Abrams P, Cardozo L, Fall M et al (2002) The standardization of terminology of lower urinary tract function: report from the standardization sub-committee of the International Continence Society. Neurourol Urodyn 21:167–178

    Article  PubMed  Google Scholar 

  2. Rosen R, Altwein J, Boyle P et al (2003) Lower urinary tract symptoms and male sexual dysfunction: the multinational survey of the aging male (MSAM-7). Eur Urol 44:637–649

    Article  PubMed  Google Scholar 

  3. Irwin DE, Milson I, Hunskaar 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 50:1306–1315

    Article  PubMed  Google Scholar 

  4. Oelke M, Bachmann A, Descazeaud A et al (2013) EAU guidelines on the treatment and follow-up of non-neurogenic male lower urinary tract symptoms including benign prostatic obstruction. Eur Urol 64:118–140

    Article  PubMed  Google Scholar 

  5. Morant SV, Reilly K, Bloomfield GA, Chapple C (2008) Diagnosis and treatment of lower urinary tract symptoms suggestive of overactive bladder and bladder outlet obstruction among men in general practice in the UK. Int J Clin Pract 62:688–694

    Article  CAS  PubMed  Google Scholar 

  6. Oelke M, Burger M, Castro-Diaz D et al (2012) Diagnosis and medical treatment of lower urinary tract symptoms in adult men: applying specialist guidelines in clinical practice. BJU Int 110:710–718

    Article  PubMed  Google Scholar 

  7. Andersson KE, Chapple CR, Cardozo L et al (2009) Pharmacological treatment of overactive bladder: report from the International Consultation on Incontinence. Curr Opin Urol 19:380–394

    Article  PubMed  Google Scholar 

  8. Hefland BT, Evans RM, McVary KT (2010) A comparison of the frequencies of medical therapies for overactive bladder in men and women: analysis of more than 7.2 million aging patients. Eur Urol 57:586–591

    Article  Google Scholar 

  9. Kaplan SA, Roehrborn CG, Dmochowski R, Rovner ES, Wang JT, Guan Z (2006) Tolterodine extended release improves overactive bladder symptoms in men with overactive bladder and nocturia. Urology 68:328–332

    Article  PubMed  Google Scholar 

  10. Roehrborn CG, Abrams P, Rovner ES, Kaplan SA, Herschorn S, Guan Z (2006) Efficacy and tolerability of tolterodine extended-release in men with overactive bladder and urgency urinary incontinence. BJU Int 97:1003–1006

    Article  CAS  PubMed  Google Scholar 

  11. Kaplan SA, Goldfischer ER, Steers WD, Gittelman M, Andoh M, Forero-Schwanhaeuser S (2010) Solifenacin treatment in men with overactive bladder: effects on symptoms and patient-reported outcomes. Aging Male 13:100–107

    Article  CAS  PubMed  Google Scholar 

  12. Temml C, Heidler S, Ponholzer A, Madersbacher S (2005) Prevalence of the overactive bladder syndrome by applying the International Continence Society definition. Eur Urol 2005:622–627

    Article  Google Scholar 

  13. Milson I, Kaplan SA, Coyne KS, Sexton CC, Kopp ZS (2012) Effect of bothersome overactive bladder symptoms on health-related quality of life, anxiety, depression, and treatment seeking in the United States: results from EpiLUTS. Urology 80:90–96

    Article  Google Scholar 

  14. Chapple CR, Rechberger T, Al-Shukri S 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 93:303–310

    Article  CAS  PubMed  Google Scholar 

  15. Cardozo L (2004) Randomized, double-blind placebo-controlled trial of once-daily antimuscarinic agent solifenacin succinate in patients with overactive bladder. J Urol 172:1919–1924

    Article  CAS  PubMed  Google Scholar 

  16. Kelleher CJ, Cardozo L, Chapple CR, Haab F, Ridder AM (2005) Improved quality of life in patients with overactive bladder symptoms treated with solifenacin. BJU Int 95:81–85

    Article  PubMed  Google Scholar 

  17. Fox C, Richardson K, Maidment ID et al (2011) Anticholinergic medication use and cognitive impairment in the older population: the medical research council cognitive function and ageing study. J Am Geriatr Soc 59:1477–1483

    Article  PubMed  Google Scholar 

  18. Whalley LJ, Sharma S, Fox HC et al (2012) Anticholinergic drugs in late life: adverse effects on cognition but not on progress to dementia. J Alzheimers Dis 1:253–261

    Google Scholar 

  19. Barry MJ, Fowler FJ Jr, O’Leary MP et al (1992) The American Urological Association symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Association. J Urol 148:1549–1557

    CAS  PubMed  Google Scholar 

  20. Zinner N, Harnett M, Sabounjian L, Sandage B, 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 173:1639–1643

    Article  PubMed  Google Scholar 

  21. Kelleher CJ, Ld Cardozo, Khullar V et al (1997) A new questionnaire to assess the quality of life of urinary incontinent women. Br J Obst Gynaecol 104:1374–1379

    Article  CAS  Google Scholar 

  22. Folstein MF, Fostein SE, McHugh PR (1975) “Mini-mental state”. A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res 12:189–198

    Article  CAS  PubMed  Google Scholar 

  23. Fitzpatrick JM, Desgrandchamps F, Adjali K, Gomez Guerra L, Hong SJ, El Khalid S, Ratana-Olarn K (2011) Management of acute urinary retention: a worldwide survey of 6074 men with benign prostatic hyperplasia. BJU Int 109:89–95

    Google Scholar 

  24. Negro CLA, Muir GH (2012) Chronic urinary retention in men: how we define it, and how does it affect treatment outcome. BJU Int 110:1590–1594

    Article  PubMed  Google Scholar 

  25. Kaplan SA, McCammon K, Fincher R, Fakhoury A, He W (2009) Safety and tolerability of solifenacin add-on therapy to α-blocker treated men with residual urgency and frequency. J Urol 182:2825–2830

    Article  PubMed  Google Scholar 

  26. Gromley EA, Lightner DJ, Burgio KL et al (2012) Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline. J Urol 188(6 Suppl):2455–2463

    Article  Google Scholar 

  27. Theobald K, Capan M, Herbold M, Schinzel S, Hundt F (2009) Quality assurance in non-interventional studies. Ger Med Sci 7: Doc29. doi:10.3205/000088

  28. Concato J, Shah N, Horwitz RI (2000) Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med 342:1887–1892

    Article  CAS  PubMed Central  PubMed  Google Scholar 

Download references

Acknowledgments

We thank the participating urologists for their help in data collection. Astellas GmbH, Germany, provided financial support for this study. Tanja Fielenbach and Michael Mader (Medidata, Germany) conducted the statistical analysis, funded by Astellas. Writing and editing assistance was provided by C. Krcmar, CRKrcmar Medical Communications, and was funded by Astellas. All authors have received consulting and lecture fees from Astellas. M. Vogel is an employee of Astellas GmbH. No remuneration was awarded to the authors for their participation in this study.

Author information

Authors and Affiliations

  1. Department of Urology and Pediatric Urology, Julius-Maximilians-University Medical Center, Oberdürrbacher Straße 6, 97080, Würzburg, Germany

    Maximilian Burger

  2. Urology Center, Düsseldorf, Germany

    Dietmar Betz

  3. Department of Urology, University Medical Center of the Johannes-Gutenberg University, Mainz, Germany

    Christian Hampel

  4. Astellas Pharma GmbH, Munich, Germany

    Monika Vogel

Authors
  1. Maximilian Burger
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Dietmar Betz
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Christian Hampel
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Monika Vogel
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Maximilian Burger.

Additional information

This study was registered at www.vfa.de/nis, number NIS Vesi 10 (MOVE).

Electronic supplementary material

Below is the link to the electronic supplementary material.

Supplementary material 1 (DOCX 20 kb)

Rights and permissions

Reprints and permissions

About this article

Cite this article

Burger, M., Betz, D., Hampel, C. et al. Efficacy and tolerability of solifenacin in men with overactive bladder: results of an observational study. World J Urol 32, 1041–1047 (2014). https://doi.org/10.1007/s00345-013-1179-z

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00345-013-1179-z

Keywords

Search

Navigation