NCT00822913

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.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University Of Perugia · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Parkinson's Disease
• Multiple System Atrophy
• Detrusor Overactivity

Interventions

Type	Name	Description
DRUG	Intravesical injection of Botulinum A toxin	One treatment, 200 U vials diluted in 20 ml normal saline

Timeline

• Start date: 2008-06-01
• Primary completion: 2008-12-01
• Completion: 2009-12-01
• First posted: 2009-01-15
• Last updated: 2009-01-15