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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00822913

Acronym

Botox-PD

Enrollment

Registered

2009-01-15

Start date

2008-06-30

Completion date

2009-12-31

Last updated

2009-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Detrusor Overactivity, Multiple System Atrophy, Parkinson's Disease

Keywords

Botulinum A toxin, Parkinson's disease

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.

Interventions

DRUGIntravesical injection of Botulinum A toxin

One treatment, 200 U vials diluted in 20 ml normal saline

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026