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McDonagh MS, Selover D, Santa J, et al. Drug Class Review: Agents for Overactive Bladder: Final Report Update 4 [Internet]. Portland (OR): Oregon Health & Science University; 2009 Mar.

Cover of Drug Class Review: Agents for Overactive Bladder

Drug Class Review: Agents for Overactive Bladder: Final Report Update 4 [Internet].

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Appendix D. Excluded trials

Trials in a foreign language

Xia, T., Su, R. S., Tao, X. C., Yan, J. Z., et al. Clinical Evaluation on the Efficacy and Safety of Tolterodine in the Treatment for Overactive Bladder. The Chinese Journal of Clinical Pharmacology. 2001;17(2):83–86.

Takayasu, H., Ueno, A., Tsuchida, S., et al. Clinical evaluation of propiverine hydrochloride (P-4) for the treatment of patients with urinary frequency - A double-blind controlled study using flavoxate hydrochloride. Nishinihon Journal of Urology. 1990;52(2):248–258.

Trials with an ineligible outcome

Lee, J. Y., Kim, H. W., Lee, S. J., Koh, J. S., Suh, H. J., Chancellor, M. B. Comparison of doxazosin with or without tolterodine in men with symptomatic bladder outlet obstruction and an overactive bladder. BJU Int. 2004;94(6):817–820.

Giannitsas, K., Perimenis, P., Athanasopoulos, A., Gyftopoulos, K., Nikiforidis, G., Barbalias, G. Comparison of the efficacy of tolterodine and oxybutynin in different urodynamic severity grades of idiopathic detrusor overactivity. Eur Urol. Dec 2004;46(6):776–782; discussion 782–773.

Altan-Yaycioglu, R., Yaycioglu, O., Aydin Akova, Y., Guvel, S., Ozkardes, H. Ocular side-effects of tolterodine and oxybutynin, a single-blind prospective randomized trial. Br J Clin Pharmacol. 2005;59(5):588–592.

Trials with an ineligible drug or intervention

Robinson, J. M., Brocklehurst, J. C. Emepronium bromide and flavoxate hydrochloride in the treatment of urinary incontinence associated with detrusor instability in elderly women. Br J Urol. 1983;55(4):371–376.

Jarvis, G. J. A controlled trial of bladder drill and drug therapy in the management of detrusor instability. Br J Urol. 1981;53(6):565–566.

Herschorn, S., Becker, D., Miller, E., Thompson, M., Forte, L. Impact of a health education intervention in overactive bladder patients. Canadian Journal of Urology. Dec 2004;11(6):2430–2437.

Guay, D. R., New, K. Pharmacokinetics of oxybutynin transdermal delivery in healthy volunteers and patients with overactive bladder (OAB). Ashp Midyear Clinical Meeting. 2002;37(DEC).

Diokno, A. C., Catipay, J. R. C., Steinert, B. W. Office assessment of patient outcome of pharmacologic therapy for urge incontinence. Int Urogyn J. 2002;13(5):334–338.

Trials in an ineligible population

Dahm, T. L., Ostri, P., Kristensen, J. K., et al. Flavoxate treatment of micturition disorders accompanying benign prostatic hypertrophy: a double-blind placebo-controlled multicenter investigation. Urol Int. 1995;55(4):205–208.

Chancellor, M. B., Appell, R. A., Sathyan, G., Gupta, S. K. A comparison of the effects on saliva output of oxybutynin chloride and tolterodine tartrate. Clin Ther. 2001;23(5):753–760.

Chancellor, M., Appell, R. A., Sathyan, G., Gupta, S. Effect on salivary output following controlled-release oxybutynin and tolterodine. Neur Urodyn. 2000;19(4):28–31.

Benvenuti, C., Cova, A., Simonazzi, I. Urinary kinetics and tolerability of oral flavoxate in man. Farmaco Ed Prat. 1977;32(Feb):99–107.

Trials with an ineligible design

Wallace, S. A., Roe, B., Williams, K., Palmer, M. Bladder training for urinary incontinence in adults.[update of Cochrane Database Syst Rev. 2000;(2):CD001308; PMID: 10796768]. Cochrane Database of Systematic Reviews. 2004;1.

Schwantes, U., Topfmeier, P. Importance of pharmacological and physicochemical properties for tolerance of antimuscarinic drugs in the treatment of detrusor instability and detrusor hyperreflexia - Chances for improvement of therapy. Int J Clin Pharmacol Ther. 1999;37(5):209–218.

Millard, R. J., Asia Pacific Tolterodine Study, G. Clinical efficacy of tolterodine with or without a simplified pelvic floor exercise regimen. Neur Urodyn. 2004;23(1):48–53.

Michel, M. C., de la Rosette, J. J., Piro, M., Goepel, M. Does concomitant stress incontinence alter the efficacy of tolterodine in patients with overactive bladder? J Urol. 2004;172(2):601–604.

Burton, G. A randomised, cross-over trial comparing oxybutinin taken three times a day or taken ‘when needed’. Neur Urodyn. 1994;13(4):351–352.

Burgio, K. L., Matthews, K. A., Engel, B. T. Prevalence, incidence and correlates of urinary incontinence in healthy, middle-aged women. J Urol. 1991;146(5):1255–1259.

Atan, A., Konety, B. R., Erickson, J. R., Yokoyama, T., Kim, D. Y., Chancellor, M. B. Tolterodine for overactive bladder: time to onset of action, preferred dosage, and 9-month follow-up. Techniques in Urology. 1999;5(2):67–70.

Trials with an ineligible duration of study

Milani, R., Scalambrino, S., Carrera, S., Pezzoli, P., Ruffmann, R. Comparison of flavoxate hydrochloride in daily dosages of 600 versus 1200 mg for the treatment of urgency and urge incontinence. J Int Med Res. 1988;16(3):244–248.

Milani, R., Scalambrino, S., Carrera, S., Pezzoli, P., Ruffmann, R. Flavoxate hydrochloride for urinary urgency after pelvic radiotherapy: comparison of 600 mg versus 1200 mg daily dosages. J Int Med Res. 1988;16(1):71–74.

Hooper, P., Tincello, D. G., Richmond, D. H. The use of salivary stimulant pastilles to improve compliance in women taking oxybutynin hydrochloride for detrusor instability: A pilot study. Br J Urol. 1997;80(3):414–416.

Briggs, R. S., Castleden, C. M., Asher, M. J. The effect of flavoxate on uninhibited detrusor contractions and urinary incontinence in the elderly. J Urol. 1980;123(5):665–666.

Excluded Studies Update 4

3=Wrong intervention, 4=wrong population, 6=wrong study design

Excluded studiesExclusion codes
Head-to-head trials
Armstrong RB, Dmochowski RR, Sand PK, et al. Safety and tolerability of extended-release oxybutynin once daily in urinary incontinence: combined results from two phase 4 controlled clinical trials. International Urology & Nephrology. 2007;39(4):1069–1077.6
Horstmann M, Schaefer T, Aguilar Y, Stenzl A, Sievert KD. Neurogenic bladder treatment by doubling the recommended antimuscarinic dosage. Neurourology & Urodynamics. 2006;25(5):441–445.4
Active control trials
Chapple C, Van Kerrebroeck P, Tubaro A, et al. Clinical efficacy, safety, and tolerability of once-daily fesoterodine in subjects with overactive bladder. European Urology. Oct 2007;52(4):1204–1212.3
Kaplan SA, Roehrborn CG, Rovner ES, et al. Tolterodine and tamsulosin for treatment of men with lower urinary tract symptoms and overactive bladder: a randomized controlled trial. [erratum appears in JAMA. 2007 Mar 21:297(11):1195]. JAMA. Nov 15 2006;296(19):2319–2328.3
Robinson D, Cardozo L, Terpstra G, et al. A randomized double- blind placebo-controlled multicentre study to explore the efficacy and safety of tamsulosin and tolterodine in women with overactive bladder syndrome. BJU International. Oct 2007;100(4):840–845.3
Song C, Park JT, Heo KO, Lee KS, Choo M-S. Effects of bladder training and/or tolterodine in female patients with overactive bladder syndrome: a prospective, randomized study. Journal of Korean Medical Science. Dec 2006;21(6):1060–1063.6
Wang AC, Chih S-Y, Chen M-C. Comparison of electric stimulation and oxybutynin chloride in management of overactive bladder with special reference to urinary urgency: a randomized placebo- controlled trial. Urology. Nov 2006;68(5):999–1004.6
Systematic Review
Tulikangas PK, Ayers A, O’Sullivan DM, Tulikangas PK, Ayers A, O’Sullivan DM. A meta-analysis comparing trials of antimuscarinic medications funded by industry or not. BJU International. Aug 2006;98(2):377–380.6
Copyright © 2009, Oregon Health & Science University, Portland, Oregon.
Bookshelf ID: NBK47188
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