Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-24 @ 10:01 PM
NCT ID:
NCT00345332
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
21 Years
Maximum Age:
90 Years
Study:
NCT00345332
Study Brief:
Protocol Section:
NCT00345332