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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03033355 |
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Date of registration:
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15/07/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Central Nervous System Changes Following BotulinumtoxinA Injection in the Bladder
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Scientific title:
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A Prospective Study of Higher Neural Control Changes Following Intradetrusor Injection of BotulinumtoxinA in Patients With Multiple Sclerosis and Lower Urinary Tract Symptoms. |
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Date of first enrolment:
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February 2014 |
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Target sample size:
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28 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03033355 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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United States
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Contacts
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Name:
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Rose Khavari, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Methodist Hospital System |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with clinical diagnosis of neurogenic bladder.
- History of any neurologic illness or injury (including but not limited to spinal cord
injury, Multiple Sclerosis, spina bifida, Parkinson's, major spine surgery).
- 18 years or older.
- Female patients.
Exclusion Criteria:
- Male
- History of any incontinence surgery (sling, MMK, Burch).
- History of any lower urinary tract surgery or manipulation (urethral dilation).
- Positive urine pregnancy test at enrollment .
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Detrusor, Overactive
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Lower Urinary Tract Symptoms
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Neurogenic Bladder
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Urge Incontinence
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Intervention(s)
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Drug: Intradetrusor injection of Botulinum Toxin-A
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Primary Outcome(s)
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Blood Oxygen Level Dependent (BOLD) Signals in brain
[Time Frame: 2 months]
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Secondary Outcome(s)
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Urodynamic study data
[Time Frame: 2 months]
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Secondary ID(s)
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Pro00010110
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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