Botulinum Toxin Type A Versus Oral Oxybutynin ER in Spinal Cord Injured Patients With Neurogenic Detrusor Overactivity
Overactive bladder is a condition associated with symptoms of feeling the urge to urinate, urinating often, and may or may not be accompanied by leakage of urine. A patient who has a spinal cord injury (SCI) often suffers from an overactive bladder which often leads to urinary incontinence (UI - an unwanted leakage of urine).
Current treatment for incontinence in some SCI patients is clean intermittent self-catheterization (CIC). This is a procedure done by inserting a catheter (a soft, hollow tube) into the urethra into the bladder in order to empty the bladder. However, CIC can be associated with infection, which can make the urinary incontinence worse and can lead to kidney damage. There are drugs that may help with the incontinence but they are likely to cause dry mouth, constipation, and blurred vision.
BoNT-A bladder injections have been studied in clinical research trials. The results have shown an improvement in urinary symptoms by reducing how often urine leakage occurs and by increasing the amount of urine the bladder can hold.
This purpose of this clinical trial is to see if BoNT-A is safe and effective when injected into the bladder for the treatment of UI and if it works better than a drug that is taken by mouth. A second purpose of the study is to perform research tests on the urine samples provided by the volunteers. Urine presents a rich source of information for bladder diseases and the biomarkers (the chemical make-up of the urine cells) will be examined to learn if there are yet undiscovered reasons for urinary diseases. These tests would be very beneficial because the results would lead to better treatment of the urinary diseases.
Volunteers will be randomized to one of two treatments. The treatment is determined by chance like the toss of a coin. There will be a 50-50 chance of receiving either treatment. The treatments are BoNT-A bladder injection and a placebo oral capsule once a day or placebo bladder injection and oxybutynin ER (like Ditropan) capsule once a day. Placebo contains no active medicine. Participation in this study will be about 2 years and involve 10 visits to the clinic. The risks of bladder BoNT-A injection are very small but include bleeding, infection, and the rare risk of spread of BoNT-A to other muscles causing weakness. Side effects of oxybutynin ER include dry mouth, constipation, and blurred vision. The potential benefits to the volunteer include improvement in the urinary incontinence symptoms, decrease in the number of required catheterizations, and an ease of the financial burden of buying protective garments.
Neurogenic Detrusor Overactivity
Drug: onabotulinumtoxin A
Drug: Oxybutynin ER
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Multicenter, Double-Blind, Randomized Study of the Safety and Efficacy of Botulinum Toxin Type A (BoNT-A) Versus Oral Oxybutynin in Spinal Cord Injured Patients With Neurogenic Detrusor Overactivity (Protocol Number 11-09-10-04)|
- The primary endpoint of the study will be a 50% greater reduction in mean daily incontinent episodes in the BoNT-A treated group compared to the oxybutynin ER treated group. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- The utility of urinary inflammatory markers as statistically significant predictors of treatment response. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||September 2016|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
ARM 1: BoNT-A injection + placebo oral capsule
BoNT-A 200 U (treatment 1)/ BoNT-A 200 U (treatment 2)/ BoNT-A 200 U (treatment 3) and placebo oral capsule daily
Drug: onabotulinumtoxin A
BoNT-A will be the active formulation. Each vial of BoNT-A Purified Neurotoxin Complex, Formulation No. 9060X, contains: 100 units (U) of Clostridium botulinum toxin type A, 0.5 mg albumin (human), and 0.9 mg sodium chloride in a sterile, vacuum-dried form without a preservative. One U corresponds to the calculated median lethal intraperitoneal dose (LD50) in mice. A 0.9% sterile saline (without preservative) for injection will be used as diluent for BoNT-A.
Each treatment session will be administered as 20 injections each of 1 mL (10U/ml), evenly distributed into the bladder.
ARM 2: Placebo injection + oxybutynin ER
Placebo injection (treatment 1)/ BoNT-A 200 U (treatment 2)/ BoNT-A 200 U (treatment 3) and oxybutynin ER 10 mg capsule daily
Drug: Oxybutynin ER
Oxybutynin ER in a 10 mg capsule will be taken daily for the course of the study.
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|United States, California|
|VA Palo Alto Health Care System|
|Palo Alto, California, United States, 94304|
|Study Director:||Christopher P. Smith, MD||Baylor College of Medicine|