Status:
TERMINATED
Botox-A Injection to Improve Bladder Function in Early Spinal Cord Injury (#H-20344)
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
U.S. Department of Education
Conditions:
Neurogenic Bladder Dysfunction Nos
Spinal Cord Injury
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to see what the effect of Botox has on bladder function for those who have recently suffered spinal cord injury. We also will study bladder tissue levels of NGF (nerve gro...
Detailed Description
Approximately 10,000 spinal cord injuries (SCI) occur each year, most of which occur in males (80%). Many of these patients develop neurogenic bladder dysfunction (NGB) characterized by overactivity o...
Eligibility Criteria
Inclusion
- Male or Females between ages of 18-50
- Patient weighs over 111 pounds
- Patient has documented Spinal Cord Injury T10 or above Thoracic Level by ASIA Score less than 8 weeks prior to the start of the study. Both complete and incomplete spinal cord injuries will be included in this study.
- Ability to complete all study requirements including voiding diary and to attend all scheduled study visits, in the opinion of the investigator
- Written informed consent has been obtained
- Patient has negative pregnancy test result if female and of child-bearing potential
- Written authorization for use and release of Health and Research Study Information has been obtained
- Patient or family member is willing and able to perform clean intermittent catheterization for duration of this study
Exclusion
- Patient has received anticholinergic medication for the treatment of overactive bladder before randomization into the study
- Patient has history or evidence of any pelvic or urological abnormalities, bladder or urethral surgery or disease, other than neurogenic bladder related to spinal cord injury, that may impact bladder function
- Patient has significant stress urinary incontinence, determined by patient history, in the opinion of the investigator
- Neurogenic detrusor overactivity (greater than 10cm elevation in pdet pressure) at baseline urodynamic screening (Day 0)
- Patient found to have significant baseline renal pathology (e.g. hydronephrosis, stones, renal mass) at Day -7
- Patient has a history of two or more treated urinary tract infections within 6 months of screening Day -7
- Patient has urinary tract infection defined as a bacteriuria count of greater than 105/ml conjoint with leukocyturia greater than 5hpf at screening Day -7
- Patient has asymptomatic urinary tract infection, defined as positive nitrites, leukocyte esterase and or blood on urine dipstick reagent strip at randomization Day 0
- Patient has history of unexplained hematuria or unexplained hematuria if greater than 5 RBC's/hpf are present at screening Day -7
- Patient has active genital infection, other than genital warts, either concurrently or within 4 weeks prior to screening Day -7
- Patient has history of interstitial cystitis, in the opinion of the investigator
- Patient has evidence of urethral obstruction, in the opinion of the investigator at screening Day -7 or randomization Day 0
- Patient uses medications with anti-platelet or anti-coagulant effects (except Lovenox) within 10 days of randomization Day 0. Lovenox 30mg SQ every 12 hours is standard of care after SCI until 2-3 months post injury. Lovenox will be stopped 24 hours before and for 48 hours after each sphincter injection or bladder biopsy procedure.
- Patient has hemophilia, or other clotting factor deficiencies or disorders that cause bleeding diathesis
- Patient has previously been treated with any endovesical pharmacologic agent (e.g. capsaicin, resiniferatoxin)
- Patient has had previous or current botulinum toxin therapy of any serotype for any condition
- Patient has a known allergy or sensitivity to any components of the study medication, anesthetics or antibiotics to be used during the study
- Any medical condition that may put the patient at increased risk with exposure to Botox® including diagnosed myasthenia gravis, Eaton-Lambert syndrome or amyotrophic lateral sclerosis
- Females who are pregnant, nursing or planning a pregnancy during the study or females of child-bearing potential who are unable or unwilling to use a reliable form of contraception during the study
- Current or previous participation in another therapeutic study within 30 days of screening Day -7
- Any condition or situation which, in the investigator's opinion, puts the patient at significant risk, could confound the study results, or may interfere significantly with the patient's participation in the study
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00711087
Start Date
July 1 2007
End Date
February 1 2010
Last Update
January 6 2021
Active Locations (2)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030
2
Memorial Hermann Hospital/The Institute of Rehabilitation and Research
Houston, Texas, United States, 77030