Effect of Botulinum Toxin A on Detrusor Overactivity and Renal Function in Chronic Spinal Cord Injured Patients
NCT ID: NCT01682603
Last Updated: 2017-03-20
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
34 participants
Study Classification
INTERVENTIONAL
Study Start Date
2012-09-30
Study Completion Date
2013-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Botulinum Toxin A on Neurogenic Detrusor Overactivity in Chronic Spinal Cord Injured Patients
NCT03063827
Neurogenic Bladder
COMPLETED
Botulinum Toxin Urethral Sphincter Injection for Dysfunctional Voiding
NCT01733290
Dysfunctional Voiding
COMPLETED
PHASE2
Different Injection Number of the Same Dose of Botulinum Toxin A on Overactive Bladder Syndrome
NCT01657409
Overactive Bladder
COMPLETED
PHASE2
Botox for Neurogenic Detrusor Overactivity and the Prevention of Autonomic Dysreflexia Following SCI
NCT02298660
Autonomic Dysreflexia
COMPLETED
PHASE4
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder
NCT00461292
Overactive Bladder
COMPLETED
PHASE3
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Study Procedure
A total of 30 patients with chronic suprasacral cord SCI will be enrolled in this study. All patients are more than 18 years old and have chronic suprasacral cord injury for more than 1 year. They have previously underwent an urodynamic study and have been proven having detrusor sphincter dyssynergia (DSD). The patients currently void by reflex, abdominal stimulation or clean intermittent catheterization (CIC), are free of indwelling catheter or cystostomy, and free of urinary tract infection (UTI) on their enrollment. During the screening period, a total glomerular filtration rate (GFR) should be less than 80 mL/min as measured by 99mTc-labelled diethylenetriamine pentaacetic acid (99mTc-DTPA) clearance renal scanning. Patients should also have adequate hand function or have a care-giver available for CIC. Other exclusion criteria include patients with detrusor underactivity and large bladder compliance, patients proven to have intrinsic sphincteric deficiency and patients who have hypersensitivity to botulinum toxin A (BTX-A) or constituent ingredients of BTX-A.
BTX-A injection will be performed in the operation room under light intravenous general anesthesia to prevent autonomic dysreflexia and hyperreflexia during cystoscopy. A total of 300U BTX-A (BOTOX, 100 U/vial, Allergan Co., Irvine, USA) dissolved into 30 mL normal saline will be injected into 30 sites of the bladder including lateral, posterior wall and dome. The injection sites are widely distributed to cover the whole bladder wall. A 14 Fr Foley catheter will be routinely inserted after BTX-A injection and patients will be discharged the next morning and followed up at out-patient clinic. All patients will be instructed to keep on CIC or abdominal stimulation as they previously performed. BTX-A injections will be repeated 6 months after the first treatment, then follow up to 24 months. Before each BTX-A injection a videourodynamic study and GFR test will be performed. Patients were also requested to report the severity of urinary incontinence by the mean daily incontinence episodes within three days, Urogenital Distress Inventory (UDI-6 Short Form), Incontinence Impact Questionnaire (IIQ-7), self assessed QoL index and the global satisfaction rate (graded as 0 to 3, indicating none, mild, moderate and very satisfied) to this treatment. The adverse events such as urinary tract infection, hematuria, difficult urination are also recorded.
This study should be approved by the Institutional Review Board and Ethics Committee of the hospital. Informed consent will be obtained before the screening and all patients are instructed about the possible complications related with BTX-A injection such as urinary retention, transient hematuria and subsequent urinary tract infection.
Patients will be classified as responders and non-responders according to their clinical presentation and urodynamic study results. Responders are considered if they become dry or reduction of incontinence episodes by 50% and have a decrease of detrusor pressure reduction by 50% of the baseline value, otherwise, they are considered as non-responders. The end-point is set at 6 months after the BTX-A injection.
There were two primary end-points: (1) the net change of the IIQ-7 and UDI-6 from baseline to 24 months, and (2) the net change of the GFR from baseline to 24 months. Secondary end-point efficacy measured the net change of the cystometric bladder capacity, bladder compliance, detrusor pressure during reflex voiding, end-filling pressure or detrusor leak-point pressure and postvoid residual volume from baseline to 24 months.
Three bladder biopsies using a small cystoscopic biopsy forceps will be performed in all patients. The biopsy will be performed at baseline and each time-point just prior to intravesical BTX-A injection. The bladder biopsy specimens will be sent to pathological department for H-E staining to exclude the possibility of carcinoma in situ, and also will be embedded in O.C.T. medium and stored at -80℃ refrigerator or liquid nitrogen tank for investigations. The bladder biopsies will be prepared for measurement of NGF messenger RNA (mRNA) and immunohistochemistry investigation of the expression of Transient Receptor Potential Vanilloid 1 (TRPV-1), purinergic receptor P2X, ligand-gated ion channel, 3 (P2X3) receptors at baseline and 6 months after each BTX-A injection, and the difference of these sensory protein expressions between responders and .non-responders to BTX-A injection.
A total of 30 patients with chronic suprasacral cord SCI will be enrolled in this study. All patients are more than 18 years old and have chronic suprasacral cord injury for more than 1 year. They have previously underwent an urodynamic study and have been proven having detrusor sphincter dyssynergia (DSD). The patients currently void by reflex, abdominal stimulation or clean intermittent catheterization (CIC), are free of indwelling catheter or cystostomy, and free of urinary tract infection (UTI) on their enrollment. During the screening period, a total glomerular filtration rate (GFR) should be less than 80 mL/min as measured by 99mTc-labelled diethylenetriamine pentaacetic acid (99mTc-DTPA) clearance renal scanning. Patients should also have adequate hand function or have a care-giver available for CIC. Other exclusion criteria include patients with detrusor underactivity and large bladder compliance, patients proven to have intrinsic sphincteric deficiency and patients who have hypersensitivity to botulinum toxin A (BTX-A) or constituent ingredients of BTX-A.
BTX-A injection will be performed in the operation room under light intravenous general anesthesia to prevent autonomic dysreflexia and hyperreflexia during cystoscopy. A total of 300U BTX-A (BOTOX, 100 U/vial, Allergan Co., Irvine, USA) dissolved into 30 mL normal saline will be injected into 30 sites of the bladder including lateral, posterior wall and dome. The injection sites are widely distributed to cover the whole bladder wall. A 14 Fr Foley catheter will be routinely inserted after BTX-A injection and patients will be discharged the next morning and followed up at out-patient clinic. All patients will be instructed to keep on CIC or abdominal stimulation as they previously performed. BTX-A injections will be repeated 6 months after the first treatment, then follow up to 24 months. Before each BTX-A injection a videourodynamic study and GFR test will be performed. Patients were also requested to report the severity of urinary incontinence by the mean daily incontinence episodes within three days, Urogenital Distress Inventory (UDI-6 Short Form), Incontinence Impact Questionnaire (IIQ-7), self assessed QoL index and the global satisfaction rate (graded as 0 to 3, indicating none, mild, moderate and very satisfied) to this treatment. The adverse events such as urinary tract infection, hematuria, difficult urination are also recorded.
This study should be approved by the Institutional Review Board and Ethics Committee of the hospital. Informed consent will be obtained before the screening and all patients are instructed about the possible complications related with BTX-A injection such as urinary retention, transient hematuria and subsequent urinary tract infection.
Patients will be classified as responders and non-responders according to their clinical presentation and urodynamic study results. Responders are considered if they become dry or reduction of incontinence episodes by 50% and have a decrease of detrusor pressure reduction by 50% of the baseline value, otherwise, they are considered as non-responders. The end-point is set at 6 months after the BTX-A injection.
There were two primary end-points: (1) the net change of the IIQ-7 and UDI-6 from baseline to 24 months, and (2) the net change of the GFR from baseline to 24 months. Secondary end-point efficacy measured the net change of the cystometric bladder capacity, bladder compliance, detrusor pressure during reflex voiding, end-filling pressure or detrusor leak-point pressure and postvoid residual volume from baseline to 24 months.
Three bladder biopsies using a small cystoscopic biopsy forceps will be performed in all patients. The biopsy will be performed at baseline and each time-point just prior to intravesical BTX-A injection. The bladder biopsy specimens will be sent to pathological department for H-E staining to exclude the possibility of carcinoma in situ, and also will be embedded in O.C.T. medium and stored at -80℃ refrigerator or liquid nitrogen tank for investigations. The bladder biopsies will be prepared for measurement of NGF messenger RNA (mRNA) and immunohistochemistry investigation of the expression of Transient Receptor Potential Vanilloid 1 (TRPV-1), purinergic receptor P2X, ligand-gated ion channel, 3 (P2X3) receptors at baseline and 6 months after each BTX-A injection, and the difference of these sensory protein expressions between responders and .non-responders to BTX-A injection.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Spinal Cord Injuries
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Botulinum toxin A
BoNT-A (BOTOX 300U)
Group Type
EXPERIMENTAL
Botulinum toxin A
Intervention Type
DRUG
BoNT-A (BOTOX 300U)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Botulinum toxin A
BoNT-A (BOTOX 300U)
Intervention Type
DRUG
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
BoNT-A (BOTOX 300U)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Adults with age of 19 years old or above
* Patients with chronic suprasacral cord SCI will be enrolled.
* Patients will be proven having NDO by videourodynamic study during the screening period.
* They also receive 99mTc-DTPA renal scanning for GFR at baseline.
* Patients with chronic suprasacral cord SCI will be enrolled.
* Patients will be proven having NDO by videourodynamic study during the screening period.
* They also receive 99mTc-DTPA renal scanning for GFR at baseline.
Exclusion Criteria
* Patients with detrusor underactivity and large bladder compliance, patients proven to have intrinsic sphincteric deficiency
* Patients who have hypersensitivity to BTX-A or constituent ingredients of BTX-A.
* Patients who have hypersensitivity to BTX-A or constituent ingredients of BTX-A.
Minimum Eligible Age
19 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Buddhist Tzu Chi General Hospital
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Hann-Chorng Kuo
Director of Urology
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hann-Chorng Kuo, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Urology, Buddhist Tzu Chi General Hospital and Tzu Chi University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Buddhist Tzu Chi General Hospital
Hualien City, , Taiwan
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Taiwan
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
BACKGROUND
Ahmed HU, Shergill IS, Arya M, Shah PJ. Management of detrusor-external sphincter dyssynergia. Nat Clin Pract Urol. 2006 Jul;3(7):368-80. doi: 10.1038/ncpuro0521.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
BACKGROUND
Avelino A, Cruz C, Nagy I, Cruz F. Vanilloid receptor 1 expression in the rat urinary tract. Neuroscience. 2002;109(4):787-98. doi: 10.1016/s0306-4522(01)00496-1.
Reference Type
BACKGROUND
Namasivayam S, Eardley I, Morrison JF. Purinergic sensory neurotransmission in the urinary bladder: an in vitro study in the rat. BJU Int. 1999 Nov;84(7):854-60. doi: 10.1046/j.1464-410x.1999.00310.x.
Reference Type
BACKGROUND
Morrison J, Wen J, Kibble A. Activation of pelvic afferent nerves from the rat bladder during filling. Scand J Urol Nephrol Suppl. 1999;201:73-5.
Reference Type
BACKGROUND
Gabella G. The structural relations between nerve fibres and muscle cells in the urinary bladder of the rat. J Neurocytol. 1995 Mar;24(3):159-87. doi: 10.1007/BF01181533.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
BACKGROUND
Steers WD. Pathophysiology of overactive bladder and urge urinary incontinence. Rev Urol. 2002;4 Suppl 4(Suppl 4):S7-S18.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
BACKGROUND
Pannek J, Sommerfeld HJ, Botel U, Senge T. Combined intravesical and oral oxybutynin chloride in adult patients with spinal cord injury. Urology. 2000 Mar;55(3):358-62. doi: 10.1016/s0090-4295(99)00540-3.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
BACKGROUND
Shu SY, Ju G, Fan LZ. The glucose oxidase-DAB-nickel method in peroxidase histochemistry of the nervous system. Neurosci Lett. 1988 Feb 29;85(2):169-71. doi: 10.1016/0304-3940(88)90346-1.
Reference Type
BACKGROUND
Schrader AJ, Lauber J, Lechner O, Heidenreich A, Hofmann R, Buer J. Application of real-time reverse transcriptase-polymerase chain reaction in urological oncology. J Urol. 2003 May;169(5):1858-64. doi: 10.1097/01.ju.0000047363.03411.6b.
Reference Type
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.
Reference Type
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.
Reference Type
BACKGROUND
Cui M, Aoki KR. Botulinum toxin type A(BTX-A) reduces inflammatory pain in the rat formalin model. Cephalalgia 20:414, 2000.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TCGHUROL005
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Botulinum-A Toxin Injection for Detrusor Hyperreflexia in Spinal Cord Injury: A Non-Surgical Approach.
NCT00262496
WITHDRAWN
PHASE2
Injections of Botulinum Toxin A in Treatment of Patients With Detrusor Overactivity and Impaired Contractility
NCT02135341
COMPLETED
PHASE2
Botox-A Injection to Improve Bladder Function in Early Spinal Cord Injury (#H-20344)
NCT00711087
TERMINATED
PHASE2
Efficacy Comparison Between Different Management Strategies for Consistent OAB in Patients With SVMs After Surgery
NCT03280316
UNKNOWN
NA
A Long-term Follow-up Study of Botulinum Toxin Type A in Patients With Overactive Bladder as a Result of Spinal Injury or Multiple Sclerosis
NCT00876447
COMPLETED
PHASE3
Evaluation the Efficacy Between Botox Injection and Combination Pharmacotherapy in Patients With Detrusor Overactivity
NCT05968885
RECRUITING
PHASE4
Intravesical Injection of Botulinum Toxin A Versus Saline for Neurogenic Detrusor Overactivity
NCT01091727
COMPLETED
PHASE3
OnabotulinumtoxinA (onaBoNT-A) Versus Oral Oxybutynin ER
NCT01050114
UNKNOWN
PHASE3
A Safety and Efficacy Study of BOTOX® (Botulinum Toxin Type A) in Patients With Urinary Incontinence Due to Neurogenic Detrusor Overactivity or Overactive Bladder in India
NCT02590250
COMPLETED
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder
NCT00575016
TERMINATED
PHASE2
Effects and Safety of Liposome Encapsulated Botulinum Toxin A for Overactive Bladder Syndrome
NCT01167257
COMPLETED
PHASE2
Early BOTOX After Spinal Cord Injury
NCT06793683
ENROLLING_BY_INVITATION
EARLY_PHASE1
Botulinum Neurotoxin Type A (BoNT-A) in Paediatric Non-neurogenic Therapy Resistant Overactive Bladder (OAB)
NCT06569342
COMPLETED
A Comparison Study of Oxybutynin and Botulinum Toxin for Neurogenic Detrusor Overactivity
NCT01477736
COMPLETED
NA
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder
NCT00311376
COMPLETED
PHASE3
Study of Botulinum Toxin Type A (BOTOX®) to Treat Urinary Incontinence From Neurogenic Detrusor Overactivity in Belgium
NCT02072928
COMPLETED
A Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type A in Patients With Overactive Bladder (OAB)
NCT02786407
UNKNOWN
PHASE3
Intravesical Injection of Botox for Treating Therapy Refractory Overactive Bladder in Females
NCT01042119
COMPLETED
Efficacy of Botulinum Toxin Type A for the Treatment of Non-neurogenic Urinary Urge Incontinence
NCT01226706
COMPLETED
NA
Trigonal vs Non Trigonal Botox Injection in OAB.
NCT03533062
COMPLETED
NA
Refractory Urge Incontinence and Botox Injections
NCT00373789
TERMINATED
PHASE3
An Observational Study of BOTOX® for the Management of Urinary Incontinence in Patients With Idiopathic Overactive Bladder
NCT02161159
COMPLETED
A Long-Term Extension Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor Overactivity
NCT01852058
COMPLETED
PHASE3
A Safety and Efficacy Study of Botulinum Toxin Type A (BOTOX®) to Treat Urinary Incontinence Due to Neurogenic Detrusor Overactivity or Overactive Bladder in Korean Patients
NCT02601287
COMPLETED
PHASE4
Botulin-A Toxin Instillations and Overactive Bladder
NCT00583219
COMPLETED
PHASE1/PHASE2