Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00262496
Status:
WITHDRAWN
Last Update Posted:
2015-06-26
First Post:
2005-12-02
Brief Title:
Botulinum-A Toxin Injection for Detrusor Hyperreflexia in Spinal Cord Injury A Non-Surgical Approach
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Botulinum-A Toxin Injection for Detrusor Hyperreflexia in Spinal Cord Injury A Non-Surgical Approach
Status:
WITHDRAWN
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
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 andor 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 50mlcm 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 mlcm 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 Wilcoxons signed rank tests McNemars tests and Cochrans 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
RESEARCH PLAN Inclusion Criteria Male and female subjects 18-80 years of age with suprasacral SCI refractory NBOA incontinence andor 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 50mlcm 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 mlcm 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 Wilcoxons signed rank tests McNemars tests and Cochrans 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None