2013-08-012024-05-13https://scholars.lib.ntu.edu.tw/handle/123456789/644834摘要：背景/目標： 膀胱過動症（OAB）影響約 17％的婦女，目前藥物治療仍以抗毒蕈鹼藥物為主流。文獻上極少探討治療期間長短的比較，尤其同時探討治療前後尿路動力學之效果及尿液神經成長因子濃度改變之相關性。因此本研究目標為比較接受抗毒蕈鹼藥物 3個月對照 6個月兩組，以電腦隨機性且前瞻性分組，同時比較兩組間在治療前後其尿路動力學效果及尿液神經成長因子濃度變化之相關性，並探討與 OAB 相關問卷及膀胱日誌之變化。 病人及方法： 預計於三年內在台大醫院婦產部收集 300 例女性 OAB 案例，以隨機前瞻性方法，分成服用 solifenacin 藥物 3 個月或 6 個月兩組，比較治療前後下列之變化，包括：尿路動力學、二十分鐘護墊測漏試驗、尿液神經成長因子濃度、三日膀胱日誌、中文版 OABSS問卷、中文版 UDI-6 及 IIQ-7 問卷及中文版 King’s Health 問卷。 預期成果： 300 例女性 OAB 患者，約有 23％在治療後尿路動力學所見變為正常，進一步分析可得到與尿液神經成長因子濃度之關連性，以及治療期間 3個月或 6個月何者為最佳。又，在治療停藥後追蹤期間有多少比率會發生復發，並進一步分析其危險因子。 <br> Abstract: Background/Aim: Overactive bladder syndrome (OAB) affects approximately 17% of women. The first choice of treatment for female OAB is antimuscarinic drug so far. However, there are few reports in literature studying the comparison of efficacy between different periods of medication for female OAB patients. In addition, the simultaneous comparisons of urodynamic effects, urinary nerve growth factor (NGF) levels and the correlations between them pre- and post-antimuscarinic drug treatment. Thus, the aims of this randomized prospective study are to compare the outcomes in female OAB patients after 3-month versus 6-month solifenacin treatment, and changes of urodynamic effects, urinary NGF levels and the correlations between both of them. Furthermore, the changes of 3-day bladder diaries and several OAB-related questionnaires. Patients and Methods: We plan to recruit 300 cases of female OAB within three years who are prospectively randomized into receiving 3-month versus 6-month solifenacin treatment. We will compare the urodynamic effects, urinary NGF levels and outcomes as well as the changes of 3-day bladder diaries, 20-minute pad teats, OABSS, UDI-6, IIQ-7 and King’s health questionnaires before and after treatments. Expected Results: About 23% of these female OAB patients will have normalized urodynamic findings after treatment (our unpublished data). We will further analyze the correlations between the post-treatment normalized urodynamic findings and changes of urinary NGF levels between the two groups. Besides, we can elucidate which treatment period (3-month versus 6-month) is better as well as what the risk factors are for recurrence of OAB after discontinuation of solifenacin treatment. References 1. Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Van Kerrebroeck P, et al. The standardization of terminology of lower urinary tract function: report from the Standardization Sub-Committee of the International Continence Society. Neurourol Urodynam 2002;21:167-78. 2. Abrams P, Kelleher CJ, Kerr LA, Rogers RG. Overactive bladder significantly affects quality of life. Am J Manag Care 2000;6:S580-90. 3. Wein AJ, Rovner ES. Definition and epidemiology of overactive bladder. Urology 2002;60:7-12. 4. Stewart EF, Van Rooyen JB, Cundiff GW, Abrams P, Herzoq AR, Corey R, et al. Prevalence and burden of overactive bladder in the United States. World J Urol 2003;20:327-36. 5. Irwin DE, Milsom I, Hunskaar S, Reily K, Kopp Z, Herschron S, 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;1306-14. 6. Yu HJ, Liu CY, Lee KL, Lee WC, Chen TH. Overactive bladder syndrome among community-dwelling adults in Taiwan: prevalence, correlates, perception, and treatment seeking. Urol Int 2006;77:327-33. 7. Zhang W, Song Y, He X, Huang H, Xu B, Song J. Prevalence and risk factors of overactive bladder syndrome in Fuzhou Chinese women. Neurourol Urodynam 2008;25:717-21. 8. Chapple C, Khullar V, Gabriel Z, Dooley JA. The effects of antimuscarinic treatments in overactive bladder: a systemic review and met-analysis. Eur Urol 2005;48:5-26. 9. Ho CH, Chang TC, Lin HH, Liu SP, Huang KH, Yu HJ. Solifenacin and tolterodine are equally effective in the treatment of overactive bladder syndrome. J Formos Med Assoc 2010;109:702-8. 10. Hsiao SM, Chang TC, Wu WY, Chen CH, Yu HJ, Lin HH. Comparisons of urodynamic effects, therapeutic efficacy and safety of solifenacin versus tolterodine for female overactive bladder syndrome. J Obstet Gynaecol Res 2011;37:1084-91. 11. Bhide AA, Digesu A, Fernando R, Khullar V. Use of mirabegron in treating overactive bladder. Int Urogenecol J 2012;23:1345-8. 12. Chen YC, Chen CY, Kuo HC. Efficacy and adverse effects of solifenacin in the treatment of lower urinary tract symptoms in patients with overactive bladder. Urol Sci 2010;21:38-43. 13. Choo MS, Song C, Kim JH, Choi JB, Lee JY, Chung BS, et al. Changes in overactive bladder symptoms after discontinuation of successful 3-month treatment with an antimuscarinic agent: a prospective trial. J Urol 2005;174:201-4. 14. Lee SY, Choo MS, Lee JY, Oh SJ, Lee KS. Symptom change after discontinuation of successful antimuscarinic treatment in patients with overactive bladder symptoms: a randomized, multicentre trial. Int J Clin Pract 2011;65:997-1004. 15. Liu HT, Kuo HC. Urinary nerve growth factor level could be a potential biomarkers for diagnosis of overactive bladder. J Urol 2008;179:2270-4. 16. Yokoyama T, Kumon H, Nagai A. Correlation of urinary nerve growth factor level with pathogenesis of overactive bladder. Neurourol Urodynam 2008;27:417-20. 17. Liu HT, Chen CY, Kuo HC. Urinary nerve growth factor in women with overactive bladder syndrome. BJU Int 2010;107:799-803. 18. Kuo HC, Liu HT, Chancellor MB. Urinary nerve growth factor is a better biomarker than detrusor wall thickness for the assessment of overactive bladder with incontinence. Neurourol Urodynam 2010;29:482-7. 19. Liu HT, Kuo HC. Urinary nerve growth factor levels are increased in patients with bladder outlet obstruction with overactive bladder symptoms and reduced after successful medical treatment. Urology 2008;72:104-8. 20. Liu HT, Chancellor MB, Kuo HC. Decrease of urinary nerve growth factor levels after antimuscarinic therapy in patients with overactive bladder. BJU Int 2009;103:1668-72.背景/目標： 膀胱過動症（OAB）影響約 17％的婦女，目前藥物治療仍以抗毒蕈鹼藥物為主流。文獻 上極少探討治療期間長短的比較，尤其同時探討治療前後尿路動力學之效果及尿液神 經成長因子濃度改變之相關性。因此本研究目標為比較接受抗毒蕈鹼藥物 3個月對照 6 個月兩組，以電腦隨機性且前瞻性分組，同時比較兩組間在治療前後其尿路動力學效 果及尿液神經成長因子濃度變化之相關性，並探討與 OAB 相關問卷及膀胱日誌之變化。 病人及方法： 預計於三年內在台大醫院婦產部收集 300 例女性 OAB 案例，以隨機前瞻性方法，分成 服用 solifenacin 藥物 3 個月或 6 個月兩組，比較治療前後下列之變化，包括：尿路 動力學、二十分鐘護墊測漏試驗、尿液神經成長因子濃度、三日膀胱日誌、中文版 OABSS 問卷、中文版 UDI-6 及 IIQ-7 問卷及中文版 King’s Health 問卷。 預期成果： 300 例女性 OAB 患者，約有 23％在治療後尿路動力學所見變為正常，進一步分析可得 到與尿液神經成長因子濃度之關連性，以及治療期間 3個月或 6個月何者為最佳。又， 在治療停藥後追蹤期間有多少比率會發生復發，並進一步分析其危險因子。Background/Aim: Overactive bladder syndrome (OAB) affects approximately 17% of women. The first choice of treatment for female OAB is antimuscarinic drug so far. However, there are few reports in literature studying the comparison of efficacy between different periods of medication for female OAB patients. In addition, the simultaneous comparisons of urodynamic effects, urinary nerve growth factor (NGF) levels and the correlations between them pre- and post-antimuscarinic drug treatment. Thus, the aims of this randomized prospective study are to compare the outcomes in female OAB patients after 3-month versus 6-month solifenacin treatment, and changes of urodynamic effects, urinary NGF levels and the correlations between both of them. Furthermore, the changes of 3-day bladder diaries and several OAB-related questionnaires. Patients and Methods: We plan to recruit 300 cases of female OAB within three years who are prospectively randomized into receiving 3-month versus 6-month solifenacin treatment. We will compare the urodynamic effects, urinary NGF levels and outcomes as well as the changes of 3-day bladder diaries, 20-minute pad teats, OABSS, UDI-6, IIQ-7 and King’s health questionnaires before and after treatments. Expected Results: About 23% of these female OAB patients will have normalized urodynamic findings after treatment (our unpublished data). We will further analyze the correlations between the post-treatment normalized urodynamic findings and changes of urinary NGF levels between the two groups. Besides, we can elucidate which treatment period (3-month versus 6-month) is better as well as what the risk factors are for recurrence of OAB after discontinuation of solifenacin treatment. References 1. Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Van Kerrebroeck P, et al. The standardization of terminology of lower urinary tract function: report from the Standardization Sub-Committee of the International Continence Society. Neurourol Urodynam 2002;21:167-78. 2. Abrams P, Kelleher CJ, Kerr LA, Rogers RG. Overactive bladder significantly affects quality of life. Am J Manag Care 2000;6:S580-90. 3. Wein AJ, Rovner ES. Definition and epidemiology of overactive bladder. Urology 2002;60:7-12. 4. Stewart EF, Van Rooyen JB, Cundiff GW, Abrams P, Herzoq AR, Corey R, et al. Prevalence and burden of overactive bladder in the United States. World J Urol 2003;20:327-36. 5. Irwin DE, Milsom I, Hunskaar S, Reily K, Kopp Z, Herschron S, 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;1306-14. 6. Yu HJ, Liu CY, Lee KL, Lee WC, Chen TH. Overactive bladder syndrome among community-dwelling adults in Taiwan: prevalence, correlates, perception, and treatment seeking. Urol Int 2006;77:327-33. 7. Zhang W, Song Y, He X, Huang H, Xu B, Song J. Prevalence and risk factors of overactive bladder syndrome in Fuzhou Chinese women. Neurourol Urodynam 2008;25:717-21. 8. Chapple C, Khullar V, Gabriel Z, Dooley JA. The effects of antimuscarinic treatments in overactive bladder: a systemic review and met-analysis. Eur Urol 2005;48:5-26. 9. Ho CH, Chang TC, Lin HH, Liu SP, Huang KH, Yu HJ. Solifenacin and tolterodine are equally effective in the treatment of overactive bladder syndrome. J Formos Med Assoc 2010;109:702-8. 10. Hsiao SM, Chang TC, Wu WY, Chen CH, Yu HJ, Lin HH. Comparisons of urodynamic effects, therapeutic efficacy and safety of solifenacin versus tolterodine for female overactive bladder syndrome. J Obstet Gynaecol Res 2011;37:1084-91. 11. Bhide AA, Digesu A, Fernando R, Khullar V. Use of mirabegron in treating overactive bladder. Int Urogenecol J 2012;23:1345-8. 12. Chen YC, Chen CY, Kuo HC. Efficacy and adverse effects of solifenacin in the treatment of lower urinary tract symptoms in patients with overactive bladder. Urol Sci 2010;21:38-43. 13. Choo MS, Song C, Kim JH, Choi JB, Lee JY, Chung BS, et al. Changes in overactive bladder symptoms after discontinuation of successful 3-month treatment with an antimuscarinic agent: a prospective trial. J Urol 2005;174:201-4. 14. Lee SY, Choo MS, Lee JY, Oh SJ, Lee KS. Symptom change after discontinuation of successful antimuscarinic treatment in patients with overactive bladder symptoms: a randomized, multicentre trial. Int J Clin Pract 2011;65:997-1004. 15. Liu HT, Kuo HC. Urinary nerve growth factor level could be a potential biomarkers for diagnosis of overactive bladder. J Urol 2008;179:2270-4. 16. Yokoyama T, Kumon H, Nagai A. Correlation of urinary nerve growth factor level with pathogenesis of overactive bladder. Neurourol Urodynam 2008;27:417-20. 17. Liu HT, Chen CY, Kuo HC. Urinary nerve growth factor in women with overactive bladder syndrome. BJU Int 2010;107:799-803. 18. Kuo HC, Liu HT, Chancellor MB. Urinary nerve growth factor is a better biomarker than detrusor wall thickness for the assessment of overactive bladder with incontinence. Neurourol Urodynam 2010;29:482-7. 19. Liu HT, Kuo HC. Urinary nerve growth factor levels are increased in patients with bladder outlet obstruction with overactive bladder symptoms and reduced after successful medical treatment. Urology 2008;72:104-8. 20. Liu HT, Chancellor MB, Kuo HC. Decrease of urinary nerve growth factor levels after antimuscarinic therapy in patients with overactive bladder. BJU Int 2009;103:1668-72.膀胱過動症尿路動力學檢查尿液神經成長因子抗毒蕈鹼藥物Overactive bladderUrodynamic studyUrinary nerve growth factorAntimuscarinic drug