Injections of Botulinum Toxin A in Treatment of Patients With Detrusor Overactivity and Impaired Contractility

Summary

The objectives of this study is to evaluate and compare the efficacy and safety between 100 U of botulinum toxin A (BoNT-A) suburothelial injections and combined 50 U of BoNT-A suburothelial injections and 50 U urethral injection for the treatment of detrusor overactivity and inadequate contractility (DHIC) refractory to antimuscarinic agents

Timeline

Start

2014-05

Primary completion

2016-12

Completion

2016-12

Publications

• Background Abrams P, Kelleher CJ, Kerr LA, Rogers RG. Overactive bladder significantly affects quality of life. Am J Manag Care. 2000 Jul;6(11 Suppl):S580-90.
• Background 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 Jan;97(1):96-100. doi: 10.1111/j.1464-410X.2005.05889.x.
• Background Yoshimura N. Lower urinary tract symptoms (LUTS) and bladder afferent activity. Neurourol Urodyn. 2007 Oct;26(6 Suppl):908-13. doi: 10.1002/nau.20487.
• Background Chapple CR. Muscarinic receptor antagonists in the treatment of overactive bladder. Urology. 2000 May;55(5A Suppl):33-46; discussion 50. doi: 10.1016/s0090-4295(99)00492-6.
• Background Kuo HC. Urodynamic evidence of effectiveness of botulinum A toxin injection in treatment of detrusor overactivity refractory to anticholinergic agents. Urology. 2004 May;63(5):868-72. doi: 10.1016/j.urology.2003.12.007.
• Background Kessler TM, Danuser H, Schumacher M, Studer UE, Burkhard FC. Botulinum A toxin injections into the detrusor: an effective treatment in idiopathic and neurogenic detrusor overactivity? Neurourol Urodyn. 2005;24(3):231-6. doi: 10.1002/nau.20105.
• Background Werner M, Schmid DM, Schussler B. Efficacy of botulinum-A toxin in the treatment of detrusor overactivity incontinence: a prospective nonrandomized study. Am J Obstet Gynecol. 2005 May;192(5):1735-40. doi: 10.1016/j.ajog.2004.11.052.
• Background Kuo HC. Clinical effects of suburothelial injection of botulinum A toxin on patients with nonneurogenic detrusor overactivity refractory to anticholinergics. Urology. 2005 Jul;66(1):94-8. doi: 10.1016/j.urology.2005.02.002.
• Background Schulte-Baukloh H, Weiss C, Stolze T, Sturzebecher B, Knispel HH. Botulinum-A toxin for treatment of overactive bladder without detrusor overactivity: urodynamic outcome and patient satisfaction. Urology. 2005 Jul;66(1):82-7. doi: 10.1016/j.urology.2005.01.036.
• Background Schulte-Baukloh H, Weiss C, Stolze T, Herholz J, Sturzebecher B, Miller K, Knispel HH. Botulinum-A toxin detrusor and sphincter injection in treatment of overactive bladder syndrome: objective outcome and patient satisfaction. Eur Urol. 2005 Dec;48(6):984-90; discussion 990. doi: 10.1016/j.eururo.2005.06.021. Epub 2005 Jul 18.
• Background Ghei M, Maraj BH, Miller R, Nathan S, O'Sullivan C, Fowler CJ, Shah PJ, Malone-Lee J. Effects of botulinum toxin B on refractory detrusor overactivity: a randomized, double-blind, placebo controlled, crossover trial. J Urol. 2005 Nov;174(5):1873-7; discussion 1877. doi: 10.1097/01.ju.0000177477.83991.88.
• Background Rajkumar GN, Small DR, Mustafa AW, Conn G. A prospective study to evaluate the safety, tolerability, efficacy and durability of response of intravesical injection of botulinum toxin type A into detrusor muscle in patients with refractory idiopathic detrusor overactivity. BJU Int. 2005 Oct;96(6):848-52. doi: 10.1111/j.1464-410X.2005.05725.x.
• Background Popat R, Apostolidis A, Kalsi V, Gonzales G, Fowler CJ, Dasgupta P. A comparison between the response of patients with idiopathic detrusor overactivity and neurogenic detrusor overactivity to the first intradetrusor injection of botulinum-A toxin. J Urol. 2005 Sep;174(3):984-9. doi: 10.1097/01.ju.0000169480.43557.31.
• Background Kuo HC. Will suburothelial injection of small dose of botulinum A toxin have similar therapeutic effects and less adverse events for refractory detrusor overactivity? Urology. 2006 Nov;68(5):993-7; discussion 997-8. doi: 10.1016/j.urology.2006.05.054.
• Background Schmid DM, Sauermann P, Werner M, Schuessler B, Blick N, Muentener M, Strebel RT, Perucchini D, Scheiner D, Schaer G, John H, Reitz A, Hauri D, Schurch B. Experience with 100 cases treated with botulinum-A toxin injections in the detrusor muscle for idiopathic overactive bladder syndrome refractory to anticholinergics. J Urol. 2006 Jul;176(1):177-85. doi: 10.1016/S0022-5347(06)00590-8.
• Background Lucioni A, Rapp DE, Gong EM, Fedunok P, Bales GT. Intravesical botulinum type A toxin injection in patients with overactive bladder: Trigone versus trigone-sparing injection. Can J Urol. 2006 Oct;13(5):3291-5.
• Background Hoebeke P, De Caestecker K, Vande Walle J, Dehoorne J, Raes A, Verleyen P, Van Laecke E. The effect of botulinum-A toxin in incontinent children with therapy resistant overactive detrusor. J Urol. 2006 Jul;176(1):328-30; discussion 330-1. doi: 10.1016/S0022-5347(06)00301-6.
• Background Kalsi V, Apostolidis A, Popat R, Gonzales G, Fowler CJ, Dasgupta P. Quality of life changes in patients with neurogenic versus idiopathic detrusor overactivity after intradetrusor injections of botulinum neurotoxin type A and correlations with lower urinary tract symptoms and urodynamic changes. Eur Urol. 2006 Mar;49(3):528-35. doi: 10.1016/j.eururo.2005.12.012. Epub 2006 Jan 6.
• Background Hirst GR, Watkins AJ, Guerrero K, Wareham K, Emery SJ, Jones DR, Lucas MG. Botulinum toxin B is not an effective treatment of refractory overactive bladder. Urology. 2007 Jan;69(1):69-73. doi: 10.1016/j.urology.2006.09.005.
• Background Ghalayini IF, Al-Ghazo MA. Intradetrusor injection of botulinum-A toxin in patients with idiopathic and neurogenic detrusor overactivity: urodynamic outcome and patient satisfaction. Neurourol Urodyn. 2007;26(4):531-536. doi: 10.1002/nau.20403.
• Background Sahai A, Khan MS, Dasgupta P. Efficacy of botulinum toxin-A for treating idiopathic detrusor overactivity: results from a single center, randomized, double-blind, placebo controlled trial. J Urol. 2007 Jun;177(6):2231-6. doi: 10.1016/j.juro.2007.01.130.
• Background Kuo HC. Comparison of effectiveness of detrusor, suburothelial and bladder base injections of botulinum toxin a for idiopathic detrusor overactivity. J Urol. 2007 Oct;178(4 Pt 1):1359-63. doi: 10.1016/j.juro.2007.05.136. Epub 2007 Aug 16.
• Background Jeffery S, Fynes M, Lee F, Wang K, Williams L, Morley R. Efficacy and complications of intradetrusor injection with botulinum toxin A in patients with refractory idiopathic detrusor overactivity. BJU Int. 2007 Dec;100(6):1302-6. doi: 10.1111/j.1464-410X.2007.07186.x.
• Background Karsenty G, Elzayat E, Delapparent T, St-Denis B, Lemieux MC, Corcos J. Botulinum toxin type a injections into the trigone to treat idiopathic overactive bladder do not induce vesicoureteral reflux. J Urol. 2007 Mar;177(3):1011-4. doi: 10.1016/j.juro.2006.10.047.
• Background Kalsi V, Apostolidis A, Gonzales G, Elneil S, Dasgupta P, Fowler CJ. Early effect on the overactive bladder symptoms following botulinum neurotoxin type A injections for detrusor overactivity. Eur Urol. 2008 Jul;54(1):181-7. doi: 10.1016/j.eururo.2007.12.029. Epub 2007 Dec 26.
• Background Kuschel S, Werner M, Schmid DM, Faust E, Schuessler B. Botulinum toxin-A for idiopathic overactivity of the vesical detrusor: a 2-year follow-up. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Jul;19(7):905-9. doi: 10.1007/s00192-007-0548-9. Epub 2008 Jan 19.
• Background Brubaker L, Richter HE, Visco A, Mahajan S, Nygaard I, Braun TM, Barber MD, Menefee S, Schaffer J, Weber AM, Wei J; Pelvic Floor Disorders Network. Refractory idiopathic urge urinary incontinence and botulinum A injection. J Urol. 2008 Jul;180(1):217-22. doi: 10.1016/j.juro.2008.03.028. Epub 2008 May 21.
• Background White WM, Pickens RB, Doggweiler R, Klein FA. Short-term efficacy of botulinum toxin a for refractory overactive bladder in the elderly population. J Urol. 2008 Dec;180(6):2522-6. doi: 10.1016/j.juro.2008.08.030. Epub 2008 Oct 19.
• Background Khan S, Kessler TM, Apostolidis A, Kalsi V, Panicker J, Roosen A, Gonzales G, Haslam C, Elneil S, Fowler CJ, Dasgupta P. What a patient with refractory idiopathic detrusor overactivity should know about botulinum neurotoxin type a injection. J Urol. 2009 Apr;181(4):1773-8. doi: 10.1016/j.juro.2008.11.110. Epub 2009 Feb 23.
• Background Cohen BL, Barboglio P, Rodriguez D, Gousse AE. Preliminary results of a dose-finding study for botulinum toxin-A in patients with idiopathic overactive bladder: 100 versus 150 units. Neurourol Urodyn. 2009;28(3):205-8. doi: 10.1002/nau.20611.
• Background Sahai A, Sangster P, Kalsi V, Khan MS, Fowler CJ, Dasgupta P. Assessment of urodynamic and detrusor contractility variables in patients with overactive bladder syndrome treated with botulinum toxin-A: is incomplete bladder emptying predictable? BJU Int. 2009 Mar;103(5):630-4. doi: 10.1111/j.1464-410X.2008.08076.x. Epub 2008 Oct 16.
• Background Flynn MK, Amundsen CL, Perevich M, Liu F, Webster GD. Outcome of a randomized, double-blind, placebo controlled trial of botulinum A toxin for refractory overactive bladder. J Urol. 2009 Jun;181(6):2608-15. doi: 10.1016/j.juro.2009.01.117. Epub 2009 Apr 16.
• Background Kessler TM, Khan S, Panicker J, Roosen A, Elneil S, Fowler CJ. Clean intermittent self-catheterization after botulinum neurotoxin type A injections: short-term effect on quality of life. Obstet Gynecol. 2009 May;113(5):1046-1051. doi: 10.1097/AOG.0b013e3181a1f5ea.
• Background Kuo HC, Liao CH, Chung SD. Adverse events of intravesical botulinum toxin a injections for idiopathic detrusor overactivity: risk factors and influence on treatment outcome. Eur Urol. 2010 Dec;58(6):919-26. doi: 10.1016/j.eururo.2010.09.007. Epub 2010 Sep 17.
• Background Liao CH, Kuo HC. Increased risk of large post-void residual urine and decreased long-term success rate after intravesical onabotulinumtoxinA injection for refractory idiopathic detrusor overactivity. J Urol. 2013 May;189(5):1804-10. doi: 10.1016/j.juro.2012.11.089. Epub 2012 Nov 20.

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Indications