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Long Term Follow-up Study of Safety and Efficacy of Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence

NCT00915525 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 829

Last updated 2019-04-30

Study results available
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Summary

The purpose of this study is to assess the long term safety and effectiveness of botulinum toxin type A in treating patients with idiopathic overactive bladder with urinary incontinence.

Conditions

Interventions

BIOLOGICAL

botulinum toxin Type A

Botulinum toxin Type A 100U or 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Medical Director · Allergan

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-01
Primary Completion
2014-08-05
Completion
2014-08-05

Countries

  • United States
  • Belgium
  • Canada
  • Czechia
  • Germany
  • Poland
  • Russia
  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00915525 on ClinicalTrials.gov