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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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,
Sponsor: VA Office of Research and Development

Current Primary Outcome:

Original Primary Outcome:

  • 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.


Current Secondary Outcome:

Original Secondary Outcome:

  • 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.


Information By: VA Office of Research and Development

Dates:
Date Received: December 2, 2005
Date Started:
Date Completion:
Last Updated: June 25, 2015
Last Verified: June 2015