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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum toxin A | Experimental | BoNT-A (BOTOX 300U) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin A | Drug | BoNT-A (BOTOX 300U) |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Net Change of the Urinary Distress Inventory (UDI-6) | Efficacy: Net change of the UrinaryDdistress Inventory (UDI-6) from baseline and 12 months. The UDI-6 is a 6-item short forms on a 4-point scale ranging from 0 "Not at all" to 3 "Greatly". The total UDI-6 score can therefore range from 0 to 18 (asymptomatic to very symptomatic). Safety: Systemic adverse events | Baseline and 12 months |
| Net Change of the Incontinence Impact Questionnaire (IIQ-7) | Efficacy: Net change of the Incontinence Impact Questionnaire (IIQ-7) from baseline and 12 months. The IIQ-7 is a 7-item short forms on a 4-point scale ranging from 0 "Not at all" to 3 "Greatly". Total IIQ-7 score ranges = 0 to 21 The total IIQ-7 score can therefore range from 0 to 21 (asymptomatic to very symptomatic). Safety: Systemic adverse events | Baseline and 12 months |
| Net Change of the Quality of Life Index (QoL-I) | Efficacy: Net change of the quality of life index (QoL-I) from baseline and 12 months. The QoL-I on a 7-point scale ranging from 0 "Delighted" to 6 "Terrible". The QoL-I ranges 0 to 6 Safety: Systemic adverse events | Baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Net Change of the Cystometric Bladder Capacity (CBC) | Efficacy: Net change of the cystometric bladder capacity (CBC) from baseline and 12 months Safety: Systemic adverse events | Baseline and 12 months |
| Net Change of the Bladder Compliance |
| Measure | Description | Time Frame |
|---|---|---|
| Autonomic Dysreflexia | Baseline and 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hann-Chorng Kuo, M.D. | Department of Urology, Buddhist Tzu Chi General Hospital and Tzu Chi University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buddhist Tzu Chi General Hospital | Hualien City | 970 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11018603 | 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. | |
| 16835625 | 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. |
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Patients were excluded if they had an active urinary tract infection, urinary tract cancer, history of lower urinary tract surgery or chronic systemic diseases. If patients fulfilled the inclusion criteria, they were enrolled in this study.
The chronic SCI patients with urinary incontinence in Hualien Tzu Chi General Hospital were consecutively recruited into this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Botulinum Toxin A | Botulinum toxin A (BoNT-A) (BOTOX 300U) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Botulinum Toxin A | BoNT-A (BOTOX 300U) Botulinum toxin A: BoNT-A (BOTOX 300U) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Net Change of the Urinary Distress Inventory (UDI-6) | Efficacy: Net change of the UrinaryDdistress Inventory (UDI-6) from baseline and 12 months. The UDI-6 is a 6-item short forms on a 4-point scale ranging from 0 "Not at all" to 3 "Greatly". The total UDI-6 score can therefore range from 0 to 18 (asymptomatic to very symptomatic). Safety: Systemic adverse events | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 months |
|
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Botulinum Toxin A | BoNT-A (BOTOX 300U) Botulinum toxin A: BoNT-A (BOTOX 300U) |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| De nove autonomic dysreflexia | Nervous system disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hann-Chorng Kuo | Department of Urology, Buddhist Tzu Chi General Hospital and Tzu Chi University | 886-3-8561825 | 2113 | hck@tzuchi.com.tw |
Not provided
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D009477 | Hereditary Sensory and Autonomic Neuropathies |
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| C545476 | incobotulinumtoxinA |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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Bladder compliance is the result of a mathematical calculation of the volume required for a unit rise of pressure measured during a cystometric filling.
Bladder compliance is calculated by dividing the volume change by the change in bladder pressure (mL/cmH2O).
Efficacy:
Net change of the bladder compliance from baseline and 12 months
Safety:
Systemic adverse events
| Baseline and 12 months |
| Net Change of the Maximum Flow Rate (Qmax) | Efficacy: Net change of the maximum flow rate (Qmax) from baseline and 12 months Safety: Systemic adverse events | Baseline and 12 months |
| Net Change of the Void Volume | Efficacy: Net change of the void volume from baseline and 12 months Safety: Systemic adverse events | Baseline and 12 months |
| Net Change of the Detrusor Pressure (Pdet) | Efficacy: Net change of the detrusor pressure (Pdet) from baseline and 12 months Safety: Systemic adverse events | Baseline and 12 months |
| Net Change of the Postvoid Residual Volume (PVR) | Efficacy: Net change of the postvoid residual volume (PVR) from baseline and 12 months Results: Botulinum toxin A injection have increased postvoid residual urine volume in patients treated for bladder dysfunction. Treat only patients who are willing and able to initiate catheterization post-treatment, if required, for urinary retention. Safety: Systemic adverse events | Baseline and 12 months |
| 10736489 | 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. |
| 9541882 | 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. |
| 15478523 | 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. |
| 10953127 | 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. |
| 16470519 | 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. |
| 8583552 | 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. |
| 14532805 | 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. |
| 15041117 | 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. |
| 16442605 | 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. |
| 16126328 | 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. |
| 15947626 | 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. |
| 15826758 | 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. |
| 11412212 | 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. |
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| 11069181 | 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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| 14565565 | 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. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Injury Level | Number | participants |
|
| ASIA Classification | ASIA Impairment Scale A: Complete. No sensory or motor function is preserved in the sacral segments S4-S5. B: Incomplete. Sensory but not motor function is preserved below the neurological level and includes the sacral segments S4-S5. C: Incomplete. Motor function is preserved below the neurological level, and more then half of key muscles below the neurological level have a muscle grade less then 3 (Grades 0-2). D: Incomplete. Motor function is preserved below the neurological level, and at least half of key muscles below the neurological level have a muscle grade greater than or equal to 3. | Number | participants |
|
| Autonomic dysreflexia | Number | participants |
|
|
|
| Secondary | Net Change of the Cystometric Bladder Capacity (CBC) | Efficacy: Net change of the cystometric bladder capacity (CBC) from baseline and 12 months Safety: Systemic adverse events | Posted | Mean | Standard Deviation | mL | Baseline and 12 months |
|
|
|
| Secondary | Net Change of the Bladder Compliance | Bladder compliance is the result of a mathematical calculation of the volume required for a unit rise of pressure measured during a cystometric filling. Bladder compliance is calculated by dividing the volume change by the change in bladder pressure (mL/cmH2O). Efficacy: Net change of the bladder compliance from baseline and 12 months Safety: Systemic adverse events | Posted | Mean | Standard Deviation | mL/cmH2O | Baseline and 12 months |
|
|
|
| Secondary | Net Change of the Maximum Flow Rate (Qmax) | Efficacy: Net change of the maximum flow rate (Qmax) from baseline and 12 months Safety: Systemic adverse events | Posted | Mean | Standard Deviation | mL/s | Baseline and 12 months |
|
|
|
| Secondary | Net Change of the Void Volume | Efficacy: Net change of the void volume from baseline and 12 months Safety: Systemic adverse events | Posted | Mean | Standard Deviation | mL | Baseline and 12 months |
|
|
|
| Secondary | Net Change of the Detrusor Pressure (Pdet) | Efficacy: Net change of the detrusor pressure (Pdet) from baseline and 12 months Safety: Systemic adverse events | Posted | Mean | Standard Deviation | cmH2O | Baseline and 12 months |
|
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|
| Secondary | Net Change of the Postvoid Residual Volume (PVR) | Efficacy: Net change of the postvoid residual volume (PVR) from baseline and 12 months Results: Botulinum toxin A injection have increased postvoid residual urine volume in patients treated for bladder dysfunction. Treat only patients who are willing and able to initiate catheterization post-treatment, if required, for urinary retention. Safety: Systemic adverse events | Posted | Mean | Standard Deviation | mL | Baseline and 12 months |
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| Primary | Net Change of the Incontinence Impact Questionnaire (IIQ-7) | Efficacy: Net change of the Incontinence Impact Questionnaire (IIQ-7) from baseline and 12 months. The IIQ-7 is a 7-item short forms on a 4-point scale ranging from 0 "Not at all" to 3 "Greatly". Total IIQ-7 score ranges = 0 to 21 The total IIQ-7 score can therefore range from 0 to 21 (asymptomatic to very symptomatic). Safety: Systemic adverse events | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 months |
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| Primary | Net Change of the Quality of Life Index (QoL-I) | Efficacy: Net change of the quality of life index (QoL-I) from baseline and 12 months. The QoL-I on a 7-point scale ranging from 0 "Delighted" to 6 "Terrible". The QoL-I ranges 0 to 6 Safety: Systemic adverse events | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 months |
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| Other Pre-specified | Autonomic Dysreflexia | Posted | Number | participants | Baseline and 12 months |
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|
|
| 0 |
| 34 |
| 22 |
| 34 |
| Difficult urination | Renal and urinary disorders | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | Systematic Assessment |
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| Urinary tract infection | Renal and urinary disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D014947 | Wounds and Injuries |
| D009421 | Nervous System Malformations |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |