Botulinum A Toxin in Patients With Parkinson's Disease

Parkinson's Disease Clinical Trial

— Botox-PD  

Official title:

The Use of Toxin Botulinum A Toxin in Patients With Parkinson's Disease and Multiple System Disease, Affected by Refractory Detrusor Overactivity.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00822913
• Other study ID #: MA-B-PD
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: January 14, 2009
• Last updated: January 14, 2009
• Start date: June 2008
• Est. completion date: December 2009

Study information

• Verified date: January 2009
• Source: University Of Perugia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: December 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Detrusor Overactivity
• Multiple System Atrophy
• Parkinson Disease
• Parkinson's Disease
• Shy-Drager Syndrome

Intervention

Drug:
• Intravesical injection of Botulinum A toxin
One treatment, 200 U vials diluted in 20 ml normal saline

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Of Perugia	University of Roma La Sapienza

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	As primary outcome measures, patients attended for clinical evaluation (daily voiding diary an QoL questionnaire).		One, three and five months after intravesical treatment	Yes
Secondary	Urodynamic assessment, and samples were obtained for urinalysis and culture.		One, three and five months follow up	Yes