Botulinum A Toxin in Patients With Parkinson's Disease (Botox-PD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00822913|
Recruitment Status : Unknown
Verified January 2009 by University Of Perugia.
Recruitment status was: Enrolling by invitation
First Posted : January 15, 2009
Last Update Posted : January 15, 2009
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease Multiple System Atrophy Detrusor Overactivity||Drug: Intravesical injection of Botulinum A toxin||Phase 4|
Patients included will have overactive bladder symptoms refractory to medical therapy. Other causes of overactive bladder symptoms including urogenital prolapse and recurrent urinary tract infections were excluded. None of the patients will be under anticoagulant therapy or drugs interfering with neuromuscular transmission. The study was approved by the local ethical committee and patients gave their informed consent. Patients will be informed about the possible need for intermittent catheterization after BoNT/A treatment.
As outcome measures we assessed clinical and urodynamic variables.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Use of Toxin Botulinum A Toxin in Patients With Parkinson's Disease and Multiple System Disease, Affected by Refractory Detrusor Overactivity.|
|Study Start Date :||June 2008|
|Estimated Primary Completion Date :||December 2008|
|Estimated Study Completion Date :||December 2009|
Experimental: Botulinum A toxin
Botulinum A toxin intravesical injection
Drug: Intravesical injection of Botulinum A toxin
One treatment, 200 U vials diluted in 20 ml normal saline
Other Name: Allergan
- 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 ]
- Urodynamic assessment, and samples were obtained for urinalysis and culture. [ Time Frame: One, three and five months follow up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00822913
|Principal Investigator:||Antonella Giannantoni, M.D.||University Of Perugia|