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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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19 February 2015 |
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Main ID: |
NCT00822913 |
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Date of registration:
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14/01/2009 |
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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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Botulinum A Toxin in Patients With Parkinson's Disease
Botox-PD |
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Scientific title:
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The Use of Toxin Botulinum A Toxin in Patients With Parkinson's Disease and Multiple System Disease, Affected by Refractory Detrusor Overactivity. |
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Date of first enrolment:
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June 2008 |
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Target sample size:
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20 |
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Recruitment status: |
Enrolling by invitation |
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URL:
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http://clinicaltrials.gov/show/NCT00822913 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Contacts
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Name:
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Antonella Giannantoni, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Of Perugia |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with overactive bladder symptoms refractory to medical therapy.
Exclusion Criteria:
- Other causes of overactive bladder symptoms including urogenital prolapse and
recurrent urinary tract infections were excluded.
- Concomitant anticoagulant therapy or drugs interfering with neuromuscular
transmission.
- Neuromuscular disease like Lambert-Eaton syndrome.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Multiple System Atrophy
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Detrusor Overactivity
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Parkinson's Disease
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Intervention(s)
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Drug: Intravesical injection of Botulinum A toxin
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Primary Outcome(s)
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As primary outcome measures, patients attended for clinical evaluation (daily voiding diary an QoL questionnaire).
[Time Frame: One, three and five months after intravesical treatment]
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Secondary Outcome(s)
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Urodynamic assessment, and samples were obtained for urinalysis and culture.
[Time Frame: One, three and five months follow up]
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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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