Botulinum A Toxin in Patients With Parkinson's Disease

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Parkinson's Disease, Multiple System Atrophy, Detrusor Overactivity

Intervention / Treatment
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* Drug: Intravesical injection of Botulinum A toxin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botulinum A toxin<br>Botulinum A toxin intravesical injection | Drug: Intravesical injection of Botulinum A toxin<br>* One treatment, 200 U vials diluted in 20 ml normal saline<br>* Other names: Allergan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urodynamic assessment, and samples were obtained for urinalysis and culture. |  | One, three and five months follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Botulinum A toxin, Parkinson's disease