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| ID | Type | Description | Link |
|---|---|---|---|
| 17787 | Other Identifier | REB |
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The purpose of this study is to investigate the use of Botulinum Toxin A as primary therapy for children with neurogenic bladder due to spina bifida and compare results with standard oral oxybutynin therapy. This study hopes to demonstrate that Botulinum Toxin A can maintain or improve bladder storage function without side effects associated with oxybutynin use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxybutynin | Active Comparator |
| |
| Botulinum Toxin A injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxybutynin | Drug | standard oral therapy |
| |
| Botulinum Toxin A injection |
| Measure | Description | Time Frame |
|---|---|---|
| To assess urodynamic effects of intravesical botulinum toxin A injection to standard oral dose therapy | The following urodynamic parameters will be measured;
| Primary outcomes will be assessed at 3 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Calculate accrual rate | Secondary outcomes will be assessed at 6 months | |
| Calculate cross over rate | Secondary outcomes will be assessed at 6 months | |
| Calculate adverse event rates |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sumit Dave, MD | London Health Sciences Centre, Laweson Health Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Health Sciences Centre - Victoria Hospital | London | Ontario | N6A 5W9 | Canada |
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| Drug |
10 units/kg injected into the detrusor muscle using cystoscopy |
|
| Secondary outcomes will be assessed at 6 months |
| Compare the side effects of standard oral therapy compared to Botulinum toxin A injection | Secondary outcomes will be assessed at 6 months |
| Calculate drop out rate | Secondary outcomes will be assessed at 6 months |
| ID | Term |
|---|---|
| D001750 | Urinary Bladder, Neurogenic |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| 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 |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C005419 | oxybutynin |
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| 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 |
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