drugset / Trial / NCT01682603
Effect of Botulinum Toxin A on Detrusor Overactivity and Renal Function in Chronic Spinal Cord Injured Patients
NaSingle-groupOpen-labelTreatment
Summary
To investigate the clinical effect of detrusor botulinum toxin A (BoNT-A) injection on neurogenic detrusor overactivity (NDO) and renal function and to compare the difference of expressions of sensory receptors and nerve growth factor (NGF) in the bladder wall of patients respond and not respond to BoNT-A injections in chronic spinal cord injured (SCI) patients.
Timeline
- Start
- 2012-09
- Primary completion
- 2013-12
- Completion
- 2013-12
Publications
- Background Weld KJ, Graney MJ, Dmochowski RR. Clinical significance of detrusor sphincter dyssynergia type in patients with post-traumatic spinal cord injury. Urology. 2000 Oct 1;56(4):565-8. doi: 10.1016/s0090-4295(00)00761-5.
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- Background Weld KJ, Dmochowski RR. Association of level of injury and bladder behavior in patients with post-traumatic spinal cord injury. Urology. 2000 Apr;55(4):490-4. doi: 10.1016/s0090-4295(99)00553-1.
- Background Linsenmeyer TA, Bagaria SP, Gendron B. The impact of urodynamic parameters on the upper tracts of spinal cord injured men who void reflexly. J Spinal Cord Med. 1998 Jan;21(1):15-20. doi: 10.1080/10790268.1998.11719505.
- Background Ethans KD, Nance PW, Bard RJ, Casey AR, Schryvers OI. Efficacy and safety of tolterodine in people with neurogenic detrusor overactivity. J Spinal Cord Med. 2004;27(3):214-8. doi: 10.1080/10790268.2004.11753751.
- Background Schurch B, Stohrer M, Kramer G, Schmid DM, Gaul G, Hauri D. Botulinum-A toxin for treating detrusor hyperreflexia in spinal cord injured patients: a new alternative to anticholinergic drugs? Preliminary results. J Urol. 2000 Sep;164(3 Pt 1):692-7. doi: 10.1097/00005392-200009010-00018.
- Background Schulte-Baukloh H, Schobert J, Stolze T, Sturzebecher B, Weiss C, Knispel HH. Efficacy of botulinum-A toxin bladder injections for the treatment of neurogenic detrusor overactivity in multiple sclerosis patients: an objective and subjective analysis. Neurourol Urodyn. 2006;25(2):110-5. doi: 10.1002/nau.20153.
- Background Schurch B, Hauri D, Rodic B, Curt A, Meyer M, Rossier AB. Botulinum-A toxin as a treatment of detrusor-sphincter dyssynergia: a prospective study in 24 spinal cord injury patients. J Urol. 1996 Mar;155(3):1023-9. doi: 10.1016/s0022-5347(01)66376-6.
- Background Kuo HC. Botulinum A toxin urethral injection for the treatment of lower urinary tract dysfunction. J Urol. 2003 Nov;170(5):1908-12. doi: 10.1097/01.ju.0000091281.50081.f0.
- Background Reitz A, Stohrer M, Kramer G, Del Popolo G, Chartier-Kastler E, Pannek J, Burgdorfer H, Gocking K, Madersbacher H, Schumacher S, Richter R, von Tobel J, Schurch B. European experience of 200 cases treated with botulinum-A toxin injections into the detrusor muscle for urinary incontinence due to neurogenic detrusor overactivity. Eur Urol. 2004 Apr;45(4):510-5. doi: 10.1016/j.eururo.2003.12.004.
- Background Kuo HC. Therapeutic effects of suburothelial injection of botulinum a toxin for neurogenic detrusor overactivity due to chronic cerebrovascular accident and spinal cord lesions. Urology. 2006 Feb;67(2):232-6. doi: 10.1016/j.urology.2005.08.016. Epub 2006 Jan 25.
- 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 Schurch B, de Seze M, Denys P, Chartier-Kastler E, Haab F, Everaert K, Plante P, Perrouin-Verbe B, Kumar C, Fraczek S, Brin MF; Botox Detrusor Hyperreflexia Study Team. Botulinum toxin type a is a safe and effective treatment for neurogenic urinary incontinence: results of a single treatment, randomized, placebo controlled 6-month study. J Urol. 2005 Jul;174(1):196-200. doi: 10.1097/01.ju.0000162035.73977.1c.
- Background Grosse J, Kramer G, Stohrer M. Success of repeat detrusor injections of botulinum a toxin in patients with severe neurogenic detrusor overactivity and incontinence. Eur Urol. 2005 May;47(5):653-9. doi: 10.1016/j.eururo.2004.11.009. Epub 2005 Jan 15.
- Background Yiangou Y, Facer P, Ford A, Brady C, Wiseman O, Fowler CJ, Anand P. Capsaicin receptor VR1 and ATP-gated ion channel P2X3 in human urinary bladder. BJU Int. 2001 Jun;87(9):774-9. doi: 10.1046/j.1464-410x.2001.02190.x.
- Background Wiseman OJ, Fowler CJ, Landon DN. The role of the human bladder lamina propria myofibroblast. BJU Int. 2003 Jan;91(1):89-93. doi: 10.1046/j.1464-410x.2003.03802.x.
- Background Cockayne DA, Hamilton SG, Zhu QM, Dunn PM, Zhong Y, Novakovic S, Malmberg AB, Cain G, Berson A, Kassotakis L, Hedley L, Lachnit WG, Burnstock G, McMahon SB, Ford AP. Urinary bladder hyporeflexia and reduced pain-related behaviour in P2X3-deficient mice. Nature. 2000 Oct 26;407(6807):1011-5. doi: 10.1038/35039519.
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- Background Aoki KR. Evidence for antinociceptive activity of botulinum toxin type A in pain management. Headache. 2003 Jul-Aug;43 Suppl 1:S9-15. doi: 10.1046/j.1526-4610.43.7s.3.x.
- Background Durham PL, Cady R, Cady R. Regulation of calcitonin gene-related peptide secretion from trigeminal nerve cells by botulinum toxin type A: implications for migraine therapy. Headache. 2004 Jan;44(1):35-42; discussion 42-3. doi: 10.1111/j.1526-4610.2004.04007.x.
- Background Cruz F, Guimaraes M, Silva C, Reis M. Suppression of bladder hyperreflexia by intravesical resiniferatoxin. Lancet. 1997 Aug 30;350(9078):640-1. doi: 10.1016/S0140-6736(05)63330-2. No abstract available.
- Background Apostolidis A, Popat R, Yiangou Y, Cockayne D, Ford AP, Davis JB, Dasgupta P, Fowler CJ, Anand P. Decreased sensory receptors P2X3 and TRPV1 in suburothelial nerve fibers following intradetrusor injections of botulinum toxin for human detrusor overactivity. J Urol. 2005 Sep;174(3):977-82; discussion 982-3. doi: 10.1097/01.ju.0000169481.42259.54.
- Background Fowler CJ, Beck RO, Gerrard S, Betts CD, Fowler CG. Intravesical capsaicin for treatment of detrusor hyperreflexia. J Neurol Neurosurg Psychiatry. 1994 Feb;57(2):169-73. doi: 10.1136/jnnp.57.2.169.
- Background Silva C, Rio ME, Cruz F. Desensitization of bladder sensory fibers by intravesical resiniferatoxin, a capsaicin analog: long-term results for the treatment of detrusor hyperreflexia. Eur Urol. 2000 Oct;38(4):444-52. doi: 10.1159/000020322.
- Background Giannantoni A, Di Stasi SM, Stephen RL, Bini V, Costantini E, Porena M. Intravesical resiniferatoxin versus botulinum-A toxin injections for neurogenic detrusor overactivity: a prospective randomized study. J Urol. 2004 Jul;172(1):240-3. doi: 10.1097/01.ju.0000132152.53532.5d.
- Background Giannantoni A, Di Stasi SM, Nardicchi V, Zucchi A, Macchioni L, Bini V, Goracci G, Porena M. Botulinum-A toxin injections into the detrusor muscle decrease nerve growth factor bladder tissue levels in patients with neurogenic detrusor overactivity. J Urol. 2006 Jun;175(6):2341-4. doi: 10.1016/S0022-5347(06)00258-8.
- Background Patel AK, Patterson JM, Chapple CR. Botulinum toxin injections for neurogenic and idiopathic detrusor overactivity: A critical analysis of results. Eur Urol. 2006 Oct;50(4):684-709; discussion 709-10. doi: 10.1016/j.eururo.2006.07.022. Epub 2006 Aug 4.
- 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 Steers WD. Pathophysiology of overactive bladder and urge urinary incontinence. Rev Urol. 2002;4 Suppl 4(Suppl 4):S7-S18.
- Background Chartier-Kastler E, Comperat E, Ruffion A. [Disorders of bladder compliance and neurogenic bladder]. Prog Urol. 2007 May;17(3):442-7. doi: 10.1016/s1166-7087(07)92345-3. French.
- Background Sekar P, Wallace DD, Waites KB, DeVivo MJ, Lloyd LK, Stover SL, Dubovsky EV. Comparison of long-term renal function after spinal cord injury using different urinary management methods. Arch Phys Med Rehabil. 1997 Sep;78(9):992-7. doi: 10.1016/s0003-9993(97)90063-0.
- Background Gerridzen RG, Thijssen AM, Dehoux E. Risk factors for upper tract deterioration in chronic spinal cord injury patients. J Urol. 1992 Feb;147(2):416-8. doi: 10.1016/s0022-5347(17)37254-3.
- Background Weld KJ, Graney MJ, Dmochowski RR. Differences in bladder compliance with time and associations of bladder management with compliance in spinal cord injured patients. J Urol. 2000 Apr;163(4):1228-33.
- Background Giannantoni A, Scivoletto G, Di Stasi SM, Silecchia A, Finazzi-Agro E, Micali I, Castellano V. Clean intermittent catheterization and prevention of renal disease in spinal cord injury patients. Spinal Cord. 1998 Jan;36(1):29-32. doi: 10.1038/sj.sc.3100509.
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- Background Nosseir M, Hinkel A, Pannek J. Clinical usefulness of urodynamic assessment for maintenance of bladder function in patients with spinal cord injury. Neurourol Urodyn. 2007;26(2):228-33. doi: 10.1002/nau.20319.
- Background Razdan S, Leboeuf L, Meinbach DS, Weinstein D, Gousse AE. Current practice patterns in the urologic surveillance and management of patients with spinal cord injury. Urology. 2003 May;61(5):893-6. doi: 10.1016/s0090-4295(02)02518-9.
- Background MacDiarmid SA, McIntyre WJ, Anthony A, Bailey RR, Turner JG, Arnold EP. Monitoring of renal function in patients with spinal cord injury. BJU Int. 2000 Jun;85(9):1014-8. doi: 10.1046/j.1464-410x.2000.00680.x.
- Background Samson G, Cardenas DD. Neurogenic bladder in spinal cord injury. Phys Med Rehabil Clin N Am. 2007 May;18(2):255-74, vi. doi: 10.1016/j.pmr.2007.03.005.
- Background Uebersax JS, Wyman JF, Shumaker SA, McClish DK, Fantl JA. Short forms to assess life quality and symptom distress for urinary incontinence in women: the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Continence Program for Women Research Group. Neurourol Urodyn. 1995;14(2):131-9. doi: 10.1002/nau.1930140206.
- Background Chan CL, Facer P, Davis JB, Smith GD, Egerton J, Bountra C, Williams NS, Anand P. Sensory fibres expressing capsaicin receptor TRPV1 in patients with rectal hypersensitivity and faecal urgency. Lancet. 2003 Feb 1;361(9355):385-91. doi: 10.1016/s0140-6736(03)12392-6.
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- Background Yono M, Takahashi W, Pouresmail M, Johnson DR, Foster HE Jr, Weiss RM, Latifpour J. Quantification of endothelins, their receptors, and endothelin-converting enzyme mRNAs in rat genitourinary tract using real-time RT-PCR. J Pharmacol Toxicol Methods. 2002 Sep-Oct;48(2):87-95. doi: 10.1016/s1056-8719(03)00022-4.
- Background Cruz F, Avelino A, Cruz C, et al. Sensory fibers immunoreactive to the vanilloid receptor protein: Distribution in the urinary bladder. Neurourol Urodynam 19:456, 2000.
- Background Cui M, Aoki KR. Botulinum toxin type A(BTX-A) reduces inflammatory pain in the rat formalin model. Cephalalgia 20:414, 2000.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 300 iu | Other |