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Health and Quality of Life Outcomes

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Open Access 01-12-2009 | Research

Correlations among improvements in urgency urinary incontinence, health-related quality of life, and perception of bladder-related problems in incontinent subjects with overactive bladder treated with tolterodine or placebo

Authors: Philip EV Van Kerrebroeck, Con J Kelleher, Karin S Coyne, Zoe Kopp, Marina Brodsky, Joseph T Wang

Published in: Health and Quality of Life Outcomes | Issue 1/2009

Abstract

Background

Previous studies demonstrate that tolterodine extended release (ER) significantly improves urgency urinary incontinence (UUI) episodes. Instruments that measure patient-reported outcomes (PROs) provide additional information that is valuable for assessing whether clinical improvements are meaningful to the patient. This study determined the correlation of changes in bladder diary variables and other PROs in subjects with overactive bladder (OAB).

Methods

Subjects with OAB, urinary frequency, and UUI were treated with 4 mg once-daily tolterodine ER or placebo for 12 weeks. Subjects completed 7-day bladder diaries, the Patient Perception of Bladder Condition (PPBC), and the King's Health Questionnaire (KHQ) at baseline and week 12. Only subjects who reported at least some minor bladder-related problems at baseline (PPBC score ≥ 3) were included in this analysis.

Results

Reductions in UUI episodes per week were significantly greater in the tolterodine ER group (n = 500) compared with the placebo group (n = 487) at week 12 (-71% vs -33%, P < 0.0001). A significantly greater percentage of subjects in the tolterodine ER group reported improvement on the PPBC versus placebo (58% vs 45%, P < 0.0001), and 7 of 10 KHQ domains were significantly improved versus placebo (all P < 0.05). Significant correlations were found for median percentage changes in UUI episodes with changes in PPBC scores (r = 0.35,P < 0.0001) and the 7 improved KHQ domains (r = 0.16–0.32, P ≤ 0.0011). Changes in PPBC scores and all KHQ domains were significantly correlated (r = 0.13–0.38, P ≤ 0.009) in the tolterodine ER group. Correlations among endpoints in the placebo group were similar to those observed in the tolterodine ER group.

Conclusion

Improvement in UUI episodes after 12 weeks of treatment with tolterodine ER or placebo was correlated with improvements in patients' perception of their bladder-related problems and health-related quality of life. Correlations were moderate in magnitude but statistically significant, suggesting that PROs are important and relevant measures for evaluating OAB treatment.

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Abrams P, Artibani W, Cardozo L, Dmochowski R, van Kerrebroeck P, Sand P: Reviewing the ICS 2002 Terminology Report: The Ongoing Debate. Neurourol Urodyn 2006, 25: 293. 10.1002/nau.20251CrossRef

Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, Van Kerrebroeck P, Victor A, Wein A: The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Urology 2003,61(1):37–49. 10.1016/S0090-4295(02)02243-4CrossRef

Stewart WF, Van Rooyen JB, Cundiff GW, Abrams P, Herzog AR, Corey R, Hunt TL, Wein AJ: Prevalence and burden of overactive bladder in the United States. World J Urol 2003,20(6):327–336.

Milsom I, Abrams P, Cardozo L, Roberts RG, Thuroff J, Wein AJ: How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study. BJU Int 2001,87(9):760–766. 10.1046/j.1464-410x.2001.02228.xCrossRef

Irwin DE, Milsom I, Hunskaar S, Reilly K, Kopp Z, Herschorn S, Coyne KS, Kelleher C, Hampel C, Artibani W, et al.: Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: Results of the EPIC study. Eur Urol 2006, 50: 1306–1315. 10.1016/j.eururo.2006.09.019CrossRef

Andersson KE: Antimuscarinics for the treatment of overactive bladder. Lancet Neurol 2004,3(1):46–53. 10.1016/S1474-4422(03)00622-7CrossRef

Leidy NK, Revicki DA, Geneste B: Recommendations for evaluating the validity of quality of life claims for labeling and promotion. Value Health 1999, 2: 113–127. 10.1046/j.1524-4733.1999.02210.xCrossRef

Reese PR, Pleil AM, Okano GJ, Kelleher CJ: Multinational study of reliability and validity of the King's Health Questionnaire in patients with overactive bladder. Qual Life Res 2003,12(4):427–442. 10.1023/A:1023422208910CrossRef

Coyne KS, Matza LS, Kopp Z, Abrams P: The validation of the patient perception of bladder condition (PPBC): a single-item global measure for patients with overactive bladder. Eur Urol 2006,49(6):1079–1086. 10.1016/j.eururo.2006.01.007CrossRef

10.

Coyne K, Revicki D, Hunt T, Corey R, Stewart W, Bentkover J, Kurth H, Abrams P: Psychometric validation of an overactive bladder symptom and health-related quality of life questionnaire: the OAB-q. Qual Life Res 2002,11(6):563–574. 10.1023/A:1016370925601CrossRef

11.

Liberman JN, Hunt TL, Stewart WF, Wein A, Zhou Z, Herzog AR, Lipton RB, Diokno AC: Health-related quality of life among adults with symptoms of overactive bladder: results from a U.S. community-based survey. Urology 2001,57(6):1044–1050. 10.1016/S0090-4295(01)00986-4CrossRef

12.

Coyne KS, Payne C, Bhattacharyya SK, Revicki DA, Thompson C, Corey R, Hunt TL: The impact of urinary urgency and frequency on health-related quality of life in overactive bladder: results from a national community survey. Value Health 2004,7(4):455–463. 10.1111/j.1524-4733.2004.74008.xCrossRef

13.

Coyne KS, Zhou Z, Thompson C, Versi E: The impact on health-related quality of life of stress, urge and mixed urinary incontinence. BJU Int 2003,92(7):731–735. 10.1046/j.1464-410X.2003.04463.xCrossRef

14.

Abrams P, Kelleher C, Lerr L, Rogers R: Overactive bladder significantly affects quality of life. Am J Manag Care 2000, 6: S580–590.

15.

Irwin DE, Milsom I, Kopp Z, Abrams P, Cardozo L: Impact of overactive bladder symptoms on employment, social interactions and emotional well-being in six European countries. BJU Int 2006,97(1):96–100. 10.1111/j.1464-410X.2005.05889.xCrossRef

16.

Kelleher CJ, Reese PR, Pleil AM, Okano GJ: Health-related quality of life of patients receiving extended-release tolterodine for overactive bladder. Am J Manag Care 2002,8(19 Suppl):S608-S615.

17.

Homma Y, Kawabe K: Health-related quality of life of Japanese patients with overactive bladder treated with extended-release tolterodine or immediate-release oxybutynin: a randomized, placebo-controlled trial. World J Urol 2004,22(4):251–256. 10.1007/s00345-004-0455-3CrossRef

18.

Freeman R, Hill S, Millard R, Slack M, Sutherst J: Reduced perception of urgency in treatment of overactive bladder with extended-release tolterodine. Obstet Gynecol 2003,102(3):605–611. 10.1016/S0029-7844(03)00623-9CrossRef

19.

Roberts R, Bavendam T, Glasser DB, Carlsson M, Eyland N, Elinoff V: Tolterodine extended release improves patient-reported outcomes in overactive bladder: results from the IMPACT trial. Int J Clin Pract 2006, 60: 752–758. 10.1111/j.1742-1241.2006.00987.xCrossRef

20.

Abrams P, Artibani W, Gajewski JB, Hussain I: Assessment of treatment outcomes in patients with overactive bladder: importance of objective and subjective measures. Urology 2006,68(suppl 2A):17–28. 10.1016/j.urology.2006.05.044CrossRef

21.

van Kerrebroeck P, Kreder K, Jonas U, Zinner N, Wein A: Tolterodine once-daily: superior efficacy and tolerability in the treatment of the overactive bladder. Urology 2001,57(3):414–421. 10.1016/S0090-4295(00)01113-4CrossRef

22.

Kelleher CJ, Cardozo LD, Khullar V, Salvatore S: A new questionnaire to assess the quality of life of urinary incontinent women. Br J Obstet Gynaecol 1997,104(12):1374–1379.CrossRef

23.

Kelleher CJ, Pleil AM, Reese PR, Burgess SM, Brodish PH: How much is enough and who says so? The case of the King's Health Questionnaire and overactive bladder. BJOG 2004,111(6):605–612. 10.1111/j.1471-0528.2004.00129.xCrossRef

24.

Matza LS, Thompson CL, Krasnow J, Brewster-Jordan J, Zycyzynski T, Coyne KS: Test-retest reliability of four questionnaires for patients with overactive bladder: the Overactive Bladder Questionnaire (OAB-q), Patient Perception of Bladder Condition (PPBC), Urgency Questionnaire (UQ), and the Primary OAB Symptom Questionnaire (POSQ). Neurourol Urodyn 2005, 24: 215–225. 10.1002/nau.20110CrossRef

25.

Cohen J: Statistical Power Analysis for the Behavioral Sciences. 2nd edition. Hillsdale, NJ: Lawrence Erlbaum Associates; 1988.

26.

Homma Y, Paick JS, Lee JG, Kawabe K: Clinical efficacy and tolerability of extended-release tolterodine and immediate-release oxybutynin in Japanese and Korean patients with an overactive bladder: a randomized, placebo-controlled trial. BJU Int 2003,92(7):741–747. 10.1046/j.1464-410X.2003.04468.xCrossRef

27.

Michel MC, de la Rosette JJ, Piro M, Schneider T: Comparison of symptom severity and treatment response in patients with incontinent and continent overactive bladder. Eur Urol 2005,48(1):110–115. 10.1016/j.eururo.2004.11.012CrossRef

28.

Coyne KS, Elinoff V, Gordon DA, Deng DY, Brodsky M, Glasser DB, Jumadilova Z, Carlsson M: Relationships between improvements in symptoms and patient assessments of bladder condition, symptom bother and health-related quality of life in patients with overactive bladder treated with tolterodine. Int J Clin Pract 2008,62(6):925–931. 10.1111/j.1742-1241.2008.01778.xCrossRef

29.

Coyne KS, Matza LS, Thompson CL: The responsiveness of the Overactive Bladder Questionnaire (OAB-q). Qual Life Res 2005, 14: 849–855. 10.1007/s11136-004-0706-1CrossRef

30.

Coyne K, Tubaro A, Brubaker L, Bavendam T: Development and validation of patient-reported outcomes measures for overactive bladder. Urology 2006,68(suppl 2A):9–16. 10.1016/j.urology.2006.05.042CrossRef

31.

Homma Y, Yoshida M, Seki N, Yokoyama O, Kakizaki H, Gotoh M, Yamanishi T, Yamaguchi O, Takeda M, Nishizawa O: Symptom assessment tool for overactive bladder syndrome – overactive bladder symptom score. Urology 2006,68(2):318–323. 10.1016/j.urology.2006.02.042CrossRef

32.

Cardozo L, Coyne KS, Versi E: Validation of the Urgency Perception Scale. BJU Int 2005, 95: 591–596. 10.1111/j.1464-410X.2005.05345.xCrossRef

33.

Marschall-Kehrel D, Roberts RG, Brubaker L: Patient-reported outcomes in overactive bladder: the influence of perception of condition and expectation for treatment benefit. Urology 2006,68(suppl 2A):29–37. 10.1016/j.urology.2006.02.046CrossRef

Title: Correlations among improvements in urgency urinary incontinence, health-related quality of life, and perception of bladder-related problems in incontinent subjects with overactive bladder treated with tolterodine or placebo
Authors: Philip EV Van Kerrebroeck
Con J Kelleher
Karin S Coyne
Zoe Kopp
Marina Brodsky
Joseph T Wang
Publication date: 01-12-2009
Publisher: BioMed Central
Published in: Health and Quality of Life Outcomes / Issue 1/2009
Electronic ISSN: 1477-7525
DOI: https://doi.org/10.1186/1477-7525-7-13

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Correlations among improvements in urgency urinary incontinence, health-related quality of life, and perception of bladder-related problems in incontinent subjects with overactive bladder treated with tolterodine or placebo

Abstract

Background

Methods

Results

Conclusion

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Results

Conclusion

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