Botulinum A Toxin in Patients With Parkinson's Disease

Phase 4

• Conditions: Parkinson's Disease; Multiple System Atrophy; Detrusor Overactivity
• Interventions: Drug: Intravesical injection of Botulinum A toxin

• Registration Number: NCT00822913
• Lead Sponsor: University Of Perugia

Brief 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.

Study Timeline

• Study Start: 2008-06
• Primary Completion: 2008-12
• Status Verified: 2009-01
• Study First Submitted: 2009-01-14
• Study First Submitted QC: 2009-01-14
• Last Update Submitted: 2009-01-14
• Study First Posted: 2009-01-15
• Last Update Posted: 2009-01-15
• Study Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Botulinum A toxin	Intravesical injection of Botulinum A toxin	Botulinum A toxin intravesical injection

Primary Outcome Measures

Name	Time	Method
As primary outcome measures, patients attended for clinical evaluation (daily voiding diary an QoL questionnaire).	One, three and five months after intravesical treatment

Secondary Outcome Measures

Name	Time	Method
Urodynamic assessment, and samples were obtained for urinalysis and culture.	One, three and five months follow up