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

Sponsor

University Of Perugia (Other)

Overall Status

Unknown status

CT.gov ID

NCT00822913

Collaborator

University of Roma La Sapienza (Other)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease Multiple System Atrophy Detrusor Overactivity	Drug: Intravesical injection of Botulinum A toxin	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 :

Jun 1, 2008

Anticipated Primary Completion Date :

Dec 1, 2008

Anticipated Study Completion Date :

Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Allergan

Arm

Intervention/Treatment

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 Names:

Allergan

Outcome Measures

Primary Outcome Measures

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

Urodynamic assessment, and samples were obtained for urinalysis and culture. [One, three and five months follow up]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.