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Clinical Trials/NCT00822913
NCT00822913
Unknown
Phase 4

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

University Of Perugia0 sites20 target enrollmentJune 2008

Overview

Phase
Phase 4
Intervention
Intravesical injection of Botulinum A toxin
Conditions
Parkinson's Disease
Sponsor
University Of Perugia
Enrollment
20
Primary Endpoint
As primary outcome measures, patients attended for clinical evaluation (daily voiding diary an QoL questionnaire).
Last Updated
17 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2008
End Date
December 2009
Last Updated
17 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

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.

Arms & Interventions

Botulinum A toxin

Botulinum A toxin intravesical injection

Intervention: Intravesical injection of Botulinum A toxin

Outcomes

Primary Outcomes

As primary outcome measures, patients attended for clinical evaluation (daily voiding diary an QoL questionnaire).

Time Frame: One, three and five months after intravesical treatment

Secondary Outcomes

  • Urodynamic assessment, and samples were obtained for urinalysis and culture.(One, three and five months follow up)

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