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OpenTrials
Completed

NCT Number: NCT02557971

Urinary Retention Rates in Clinical Practice After Treatment With OnabotulinumtoxinA for Idiopathic Overactive Bladder

This study is a retrospective chart review of patients treated with BOTOX® for idiopathic Overactive Bladder (OAB) as standard of care in clinical practice. The study will determine the rate of post procedural urinary retention requiring catheterization and identify factors that may predict urinary retention.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, Davis, Davis, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-Patients treated with BOTOX® for Overactive Bladder.

Exclusion criteria

  • Received botulinum toxin formulations other than BOTOX® in the bladder.
  • Had symptoms of OAB associated with a neurological condition.
  • Had a history of chronic urinary retention treated with Clean Intermittent Catheterization (CIC) or indwelling catheter.

Treatment and study plan

OnabotulinumtoxinA

Drug

OnabotulinumtoxinA (BOTOX®) as prescribed in clinical practice.

Other names: BOTOX®, botulinum toxin Type A

Primary outcomes

  1. Percentage of Participants with Post-Procedure Urinary Retention requiring Catheterization

    Time frame: 12 Weeks

  2. Length of Time of Clean Intermittent Catheterization (CIC) Use

    Time frame: 12 Weeks

Secondary outcomes

  1. Percentage of Participants with Urinary Tract Infection (UTI)

    Time frame: 12 Weeks

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 23, 2015
Registry last updated
Sep 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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