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

University of Rochester

Status

Completed

Conditions

Urinary Incontinence

Treatments

Drug: Botox

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00345332

12299

Details and patient eligibility

About

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.

Full description

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

Enrollment

31 patients

Sex

Female

Ages

21 to 90 years old

Volunteers

Accepts Healthy Volunteers

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