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

January 14, 2009 updated by: University Of Perugia

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
One, three and five months after intravesical treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Of Perugia

Collaborators

University of Roma La Sapienza

Investigators

  • Principal Investigator: Antonella Giannantoni, M.D., University Of Perugia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Anticipated)

December 1, 2008

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

January 14, 2009

First Submitted That Met QC Criteria

January 14, 2009

First Posted (Estimate)

January 15, 2009

Study Record Updates

Last Update Posted (Estimate)

January 15, 2009

Last Update Submitted That Met QC Criteria

January 14, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MA-B-PD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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