Botulinum-A Toxin Injection for Detrusor Hyperreflexia in Spinal Cord Injury: A Non-Surgical Approach.

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00262496
First received: December 2, 2005
Last updated: January 20, 2009
Last verified: August 2006

December 2, 2005
January 20, 2009
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  • 50% improvement in diminished leakage measured at 2, 6, and 12 weeks and every 3 months thereafter during the 24 month duration.
  • Improvement in bladder function.
Complete list of historical versions of study NCT00262496 on ClinicalTrials.gov Archive Site
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  • Change in bladder pressure measured by videourodynamics at 6 weeks after first injection and every 3 months thereafter during the 24 month duration.
  • Change in quality of life by improvement in Urogenital Distress Inventory-6 (UDI6), SF-36 Quality of Life.
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Botulinum-A Toxin Injection for Detrusor Hyperreflexia in Spinal Cord Injury: A Non-Surgical Approach.
Botulinum-A Toxin Injection for Detrusor Hyperreflexia in Spinal Cord Injury: A Non-Surgical Approach.

The purpose of the study is to determine whether Botulinum-A toxin injected in the bladder muscle will help prevent the frequency and degree of urinary incontinence in Spinal Cord Injured and Multiple Sclerosis patients. The proposed mechanism would be that the Toxin would allow the bladder to hold more urine at a lower pressure as determined by Urodynamics. The research will answer the question whether the dosages 300 units vs 400 units are either equally vs not equally effective in helping urinary incontinece and bladder storage.

OBJECTIVE OF THE PROJECT The major aim of the present study is to use a double blind randomized clinical trial design to evaluate the long-term efficacy and safety of two different doses, 300 and 400 Units of Botulinum Toxin Type-A for the treatment of detrusor hyperreflexia (Neurogenic Bladder Overactivity). While also improving bladder capacity in spinal cord injured patients with refractory symptoms who have failed anticholinergic agents.

RESEARCH PLAN Inclusion Criteria: Male and female subjects 18-80 years of age with suprasacral SCI refractory NBOA incontinence, and/or impaired detrusor compliance associated with a small bladder capacity will be eligible. Subjects will be recruited on the basis of incontinence symptoms and adverse urodynamic parameters including impaired bladder compliance less than 50ml/cm, H20 and bladder (cystometric) capacity less than 300 ml.

Exclusion criteria: Allergy to Botulinum Toxin Type-A, pregnancy, breast-feeding women, active medical or psychiatric disorders, active urinary tract infection, coagulopathy, myasthenia gravis, upper urinary tract changes unrelated to lower tract dysfunction, and aminoglycoside use during the last three months. Furthermore, subjects with radiation cystitis (by history), vesico-ureteral reflux (by videofluoroscopy), bladder calculi (by cystoscopy) will be excluded.

Evaluation will include history and physical examination, urine analysis, urine culture and sensitivity, 24-hour voiding diary for 3 consecutive days, urine pregnancy test in female subjects of reproductive age, validated questionnaires, multichannel videourodynamics (UDS), post-void residual volume at the time of UDS, and renal ultrasound.

METHODOLOGY One week after the pre-intervention evaluation, endoscopic injection of Botulinum Toxin Type-A (300 Units or 400 Units) into the detrusor muscle will be performed. During the 24 month duration of the study, participants will take and record their regular bladder medications as Dr. Gousse (or one of his assistants) decide necessary to control their urinary symptoms. Subjects will be scheduled to return at 2, 6, and 12 weeks after the first injection session, and every 3 months thereafter. At the 2-week visit we will assess untoward effects. At the 6-week visit and every subsequent visit a focused physical examination will be carried out, along with validated questionnaires.

Participants with initial success, as defined by 50% improvement (voiding diary) in diminished leakage, improved cystometric capacity by greater than 100 ml, improved compliance by 15 ml/cm H20, 50% improvement in questionnaire scores, but who lose the initial therapeutic benefit will be considered candidates for re-injection every 6 months. Patients who continue to maintain therapeutic benefit pass 6 months after initial injection will not be re-injected and will be re-evaluated at every 3 months thereafter prior to possible re-injection. Pregnancy testing will be obtained prior to each injection session in appropriate female subjects in their reproductive years.

Depending on the type of variable being analyzed different statistical techniques will be used for these comparisons including paired sample t-tests, Wilcoxon's signed rank tests, McNemar's tests, and Cochran's Q tests. Cross-sectional as well as longitudinal analyses will be performed to compare 300 vs. 400 Unit groups with respect to each of the variables ascertained at each time point, and also with respect to changes over time for the major study end points.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Overactive Bladder
  • Urinary Incontinence
Drug: Botox
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
40
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Inclusion Criteria:

  • Patients must be 18-80 years old with suprasacral spinal cord injury (SCI) or multiple sclerosis (MS) refractory Neurogenic bladder overactivity and/or detrusor compliance associated with small bladder capacity.· Impaired bladder compliance less than 50 ml/cm, H2O and bladder (cystometric) capacity less than 300ml.-

Exclusion Criteria:

  • Allergy to Botulinum Toxin Type-A· Pregnancy· Breast-feeding women· Active medical or psychiatric disorders· Upper urinary tract changes unrelated to lower tract dysfunction· Aminoglycoside use during the last 3 months-
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00262496
3216-01
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Department of Veterans Affairs
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Principal Investigator: Angelo E Gousse, MD Miami VA Medical Center
Department of Veterans Affairs
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP