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Impact of duloxetine on quality of life for women with symptoms of urinary incontinence

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Abstract

The objective of this study was to evaluate the effectiveness of duloxetine in improving quality of life among women with stress and mixed urinary incontinence. The study included 451 women with self-reported stress incontinence episodes (≥1/week) who were randomized to duloxetine (40 mg BID) or placebo in a double-blind, usual care design. Patients and physicians were allowed to titrate, augment, and/or discontinue treatment. Concomitant treatments were permitted. The primary outcome was the Incontinence Quality of Life Questionnaire (I-QOL) score, with assessments at 3, 6, and 9 months. Other measures included the Patient Global Impression of Improvement (PGI-I) and adverse events. The adjusted mean change in I-QOL total score was greater in the duloxetine group than in the placebo group and at a level comparable to that found in previous clinical trials, but the difference between placebo and duloxetine was not statistically significant in the intent-to-treat, last observation carried forward (LOCF) analysis. The difference approached statistical significance in favor of duloxetine at 3 months (p=0.07). PGI-I ratings did not demonstrate significant superiority for duloxetine in LOCF analysis; however, study completers taking duloxetine were significantly more likely to rate themselves as “better” (70.2%) than completers taking placebo (50.8%, p<0.05). Women utilized a variety of treatment methods including pelvic floor muscle training, estrogen, anticholinergic medication, weight reduction, and smoking cessation. In this study, while mean I-QOL change scores were numerically higher for the duloxetine group than mean change scores for the placebo group, this difference was not statistically significant. Among women who completed the study on study drug, a significantly greater proportion of duloxetine women versus placebo women rated their condition to be better.

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References

  1. Diokno AC, Burgio K, Fultz NH, Kinchen KS, Obenchain R, Bump RC (2004) Medical and self-care practices reported by women with urinary incontinence. Am J Manag Care 10:69–78

    PubMed  Google Scholar 

  2. Hampel C, Wienhold D, Benken N, Eggersmann C, Thuroff JW (1997) Definition of overactive bladder and epidemiology of urinary incontinence. Urology 50:4–14

    Article  CAS  PubMed  Google Scholar 

  3. Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U et al (2002) The standardization of terminology of lower urinary tract function: report from the Standardization Subcommittee of the International Continence Society. Neurourol Urodyn 21:167–178

    Article  PubMed  Google Scholar 

  4. Fultz NH, Burgio K, Diokno AC, Kinchen KS, Obenchain R, Bump RC (2003) Burden of stress urinary incontinence for community-dwelling women. Am J Obstet Gynecol 189:1275–1282

    Article  PubMed  Google Scholar 

  5. Lightner DJ, Itano NM (1999) Treatment options for women with stress urinary incontinence. Mayo Clin Proc 74:1149–1156

    Article  CAS  PubMed  Google Scholar 

  6. Espey MJ, Downie JW, Fine A (1992) Effect of 5-HT receptor and adrenoceptor antagonists on micturition in conscious cats. Eur J Pharmacol 221:167–170

    Article  CAS  PubMed  Google Scholar 

  7. Danuser H, Thor KB (1996) Spinal 5-HT2 receptor-mediated facilitation of pudendal nerve reflexes in the anaesthetized cat. Br J Pharmacol 118:150–154

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  8. Gajewski J, Downie JW, Awad SA (1984) Experimental evidence for a central nervous system site of action in the effect of alpha-adrenergic blockers on the external urinary sphincter. J Urol 132:403–409

    CAS  PubMed  Google Scholar 

  9. Thor KB, Katofiasc MA (1995) Effects of duloxetine, a combined serotonin and norepinephrine reuptake inhibitor, on central neural control of lower urinary tract function in the chloralose-anesthetized female cat. J Pharmacol Exp Ther 274:1014–1024

    CAS  PubMed  Google Scholar 

  10. Norton PA, Zinner RN, Yalcin I, Bump RC (2002) Duloxetine versus placebo in the treatment of stress urinary incontinence. Am J Obstet Gynecol 187:40–48

    Article  CAS  PubMed  Google Scholar 

  11. Dmochowski RR, Miklos JR, Norton PA, Zinner NR, Yalcin I, Bump RC (2003) Duloxetine versus placebo for the treatment of North American women with stress urinary incontinence. J Urol 170:1259–1263

    Article  CAS  PubMed  Google Scholar 

  12. van Kerrebroeck P, Abrams P, Lange R, Slack M, Wyndaele J-J, Yalcin I, Bump RC (2004) Duloxetine UI Study Group. Duloxetine vs. placebo in the treatment of European and Canadian women with stress urinary incontinence. Br J Obstet Gynaecol 111:249–257

    Article  Google Scholar 

  13. Millard RJ, Moore K, Rencken R, Yalcin I, Bump RC (2004) For the Duloxetine UI Study Group. Duloxetine versus placebo in the treatment of stress urinary incontinence: a four continent randomized clinical trial. Br J Urol Int 93:311–318

    Article  CAS  Google Scholar 

  14. Patrick DL, Martin ML, Bushnell DM, Yalcin I, Wagner TH, Buesching DP (1999) Quality of life of women with urinary incontinence: further development of the incontinence quality of life instrument (I-QOL). Urology 53:71–76

    Article  CAS  PubMed  Google Scholar 

  15. Yalcin I, Bump RC (2003) Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol 189:98–101

    Article  PubMed  Google Scholar 

  16. Winslade J, Hutchinson DR (1992) Dictionary of clinical research. Brookwood Medical Publications, Brookwood

    Google Scholar 

  17. Bump R, Hooper C, Koke S, Yalcin I (2003) Worldwide efficacy of duloxetine after 12 weeks and 1 year in women with stress urinary incontinence (SUI): a 4-study meta-analysis. International Continence Society meeting, Florence

  18. Cardozo L, Drutz HP, Baygani SK, Bump RC (2004) Pharmacological treatment of women awaiting surgery for stress urinary incontinence. Obstet Gynecol 104:511–519

    Article  CAS  PubMed  Google Scholar 

  19. Tunis SR, Stryer DB, Clancy CM (2003) Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. JAMA 290:1624–1632

    Article  CAS  PubMed  Google Scholar 

  20. Herbison P, Hay-Smith J, Ellis G, Moore K (2003) Effectiveness of anticholinergic drugs compared with placebo in the treatment of overactive bladder: a systematic review. BMJ 326:841–844

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  21. Yalcin I, Bump RC, Versi E, Schaefer W, Benson JT (2004) Validation of a clinical algorithm indicative of urodynamic stress incontinence for use in large-scale clinical trials. J Urol 171:2321–2325

    Article  PubMed  Google Scholar 

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Acknowledgments

We would like to thank Shoshana Coleman, Amy Keating, and their project team at Quintiles for their efforts in conducting the study. We would also like to acknowledge the project management contributions of Molly Tomlin.

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Correspondence to Kraig S. Kinchen.

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Kinchen, K.S., Obenchain, R. & Swindle, R. Impact of duloxetine on quality of life for women with symptoms of urinary incontinence. Int Urogynecol J 16, 337–344 (2005). https://doi.org/10.1007/s00192-004-1270-5

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  • DOI: https://doi.org/10.1007/s00192-004-1270-5

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