A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study of Safety and Efficacy of a Single Treatment With 2 Dose Levels of BOTOX Purified Neurotoxin Complex Followed by a Treatment With BOTOX in Patients With…

Veterans Medical Research Foundation0 sitesAugust 2008

ConditionsUrinary Incontinence Urinary Bladder, Overactive

Overview

Phase: N/A
Intervention: Not specified
Conditions: Urinary Incontinence
Sponsor: Veterans Medical Research Foundation
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The specific aim of this study is to evaluate the safety and efficacy of each of 2 dosages of BOTOX® (200 U or 300 U) compared to placebo injected into the detrusor for the treatment of urinary incontinence caused by neurogenic detrusor overactivity in patients who have not been adequately managed with anticholinergic therapy.

Registry

clinicaltrials.gov

Start Date

August 2008

End Date

September 2009

Last Updated

16 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Veterans Medical Research Foundation

Eligibility Criteria

Inclusion Criteria

•Patient is male or female, aged 18 to 80 years old.
•Patient weighs ≥ 50 kg (110 lb).
•Patient has urinary incontinence as a result of neurogenic detrusor overactivity for a period of at least 3 months prior to screening as a result of spinal cord injury or multiple sclerosis, determined by documented patient history. In addition:
•Spinal cord injury patients must have a stable neurological injury level at T1 or below (cervical injuries are excluded) occurring ≥ 6 months prior to screening.
•Multiple sclerosis patients must be clinically stable in the investigator's opinion for ≥ 3 months prior to screening and have an Expanded Disability Status Scale score ≤ 6.
•Patient has detrusor overactivity (defined as a phasic rise in bladder pressure during the filling phase determined by urodynamics) demonstrated during the screening period or Day 1 (prior to randomization).
•Patient is able to complete study requirements including bladder diary completion and attend all study visits (telephone and clinic), in the opinion of the investigator.
•Patient has not been adequately managed with one or more anticholinergics for their urinary incontinence, in the opinion of the investigator. Not adequately managed is defined as an inadequate response or intolerable side effects after at least one month of anticholinergic therapy on an optimized dose.
•For patients taking anticholinergic medication for their neurogenic overactive bladder, dose is stable and patient is willing to maintain same dosing during study participation.
•Patient has a negative pregnancy result if female and of childbearing potential.

Exclusion Criteria

•Patient has history or evidence of any pelvic or urological abnormalities including but not limited to the following:
•elevated serum creatinine \> 2 times the upper limit of normal (reference range)
•history of or current hematuria, 1) if the hematuria is determined to be a pathologic condition or 2) is uninvestigated
•interstitial cystitis in the opinion of the investigator
•bladder stones within 6 months of screening
•surgery or bladder disease other than detrusor overactivity that may impact bladder function with the exception of surgeries for bladder stones (\> 6 months) and stress incontinence, uterine prolapse, rectocele, or cystocele (\>1 year) from screening
•Patient has had previous or current botulinum toxin therapy of any serotype for any urological condition or, treatment within 3 months of Randomization/Day 1 for any other condition or use.
•Patient has been immunized for any botulinum toxin serotype.
•Patient discontinued anticholinergic medication for overactive bladder \< 21 days prior to Randomization/Day
•Patient has a history or current diagnosis of bladder cancer or has urine cytology results which may indicate bladder cancer not ruled out by investigator at Randomization/Day