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

U

University Of Perugia

Status and phase

Unknown
Phase 4

Conditions

Multiple System Atrophy
Parkinson's Disease
Detrusor Overactivity

Treatments

Drug: Intravesical injection of Botulinum A toxin

Study type

Interventional

Funder types

Other

Identifiers

NCT00822913
MA-B-PD

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Botulinum A toxin
Experimental group
Description:
Botulinum A toxin intravesical injection
Treatment:
Drug: Intravesical injection of Botulinum A toxin

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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