Botulinum A Toxin in Patients With Parkinson's Disease (Botox-PD)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
University of Roma La Sapienza
Information provided by:
University Of Perugia
ClinicalTrials.gov Identifier:
NCT00822913
First received: January 14, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted

January 14, 2009
January 14, 2009
June 2008
December 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Urodynamic assessment, and samples were obtained for urinalysis and culture. [ Time Frame: One, three and five months follow up ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Botulinum A Toxin in Patients With Parkinson's Disease
The Use of Toxin Botulinum A Toxin in Patients With Parkinson's Disease and Multiple System Disease, Affected by Refractory Detrusor Overactivity.

The researchers investigated the effectiveness and safety of BoNT/A injected into the detrusor muscle in patients with PD and MSA all of whom had detrusor muscle overactivity unresponsive to conventional medical therapy.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Parkinson's Disease
  • Multiple System Atrophy
  • Detrusor Overactivity
Drug: Intravesical injection of Botulinum A toxin
One treatment, 200 U vials diluted in 20 ml normal saline
Other Name: Allergan
Experimental: Botulinum A toxin
Botulinum A toxin intravesical injection
Intervention: Drug: Intravesical injection of Botulinum A toxin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
20
December 2009
December 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00822913
MA-B-PD
Yes
Giannantoni Antonella, University of Perugia
University Of Perugia
University of Roma La Sapienza
Principal Investigator: Antonella Giannantoni, M.D. University Of Perugia
University Of Perugia
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP