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OpenTrials
Completed

NCT Number: NCT00345332

A Multi-Center Trial of Botox for Severe Urge Urinary Incontinence

The purpose of the study is to determine how effective Botox is in reducing the amount of urine leaked and which dose of Botox is more effective and safe in those who have urinary urge incontinence.

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

21 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of California at Davis, Sacramento, California, United States

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About this study

A multi-center clinical trial of Botulinum-A Toxin (Botox) for refractory urge incontinence.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Female subjects 21-90 years of age
  • subjects has urinary incontinence on 3 day bladder diary
  • subject has severe incontinence
  • urine dipstick or urine culture negative for urinary tract infection
  • cystometrogram without stress urinary leakage
  • must have failed at least one anti-cholinergic medication
  • negative urine pregnancy test on day of administration of study medication

Exclusion criteria

  • history of carcinoma of the bladder
  • presence of foreign body in the bladder, cystitis or other correctable etiology for Urge Urinary Incontinance
  • gross fecal incontinence
  • known allergy to sulfa or ciprofloxacin or to lidocaine
  • any medical condition that may put the subject at increased risk with exposure to Botox
  • females who are pregnant, breast-feeding, or planning a pregnancy during the study or who are of child-bearing potential
  • known allergy to any of the components in the study medication
  • prior documented resistance to Botox
  • evidence of recent alcohol or drug abuse
  • concurrent participation in another investigational drug or device study within 30 days

Treatment and study plan

Botox

Drug

Injected

Placebo

Drug

Injected

Primary outcomes

  1. Incontinent Episodes Per Day

    Time frame: week 13

    The number of incontinence episodes per day was recorded by each participant in a diary. All incontinence episodes were counted when calculating episodes per day at each time point.

Secondary outcomes

  1. Number of Incontinence Pads Used Per Day

    Time frame: week 13

    The number of incontinence pads used per day per day was recorded by each participant in a diary.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial of Botox for Severe Refractory Urge Urinary Incontinence

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Jun 28, 2006
Registry last updated
Jul 11, 2017

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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