Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 1
Status: | Active, not recruiting |
---|---|
Conditions: | Overactive Bladder, Hospital, Neurology, Neurology, Urology |
Therapuetic Areas: | Gastroenterology, Nephrology / Urology, Neurology, Other |
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 2/2/2019 |
Start Date: | March 2016 |
End Date: | March 31, 2019 |
A Phase III, Multicentre, Randomised, Double Blind, Parallel Group, Placebo Controlled Study To Assess The Efficacy And Safety Of One Or More Intradetrusor Treatments Of 600 Or 800 Units of Dysport® For The Treatment Of Urinary Incontinence In Subjects With Neurogenic Detrusor Overactivity Due To Spinal Cord Injury Or Multiple Sclerosis
The purpose of this study is to provide confirmatory evidence of the safety and efficacy of
two Dysport® (AbobotulinumtoxinA) doses (600 units [U] and 800 U), compared to placebo in
reducing urinary incontinence (UI) in adult subjects treated for neurogenic detrusor
overactivity (NDO) due to spinal cord injury (SCI) or multiple sclerosis (MS).
two Dysport® (AbobotulinumtoxinA) doses (600 units [U] and 800 U), compared to placebo in
reducing urinary incontinence (UI) in adult subjects treated for neurogenic detrusor
overactivity (NDO) due to spinal cord injury (SCI) or multiple sclerosis (MS).
Key Inclusion Criteria:
- Urinary Incontinence for at least 3 months prior to Screening as a result of
Neurogenic Detrusor Overactivity due to Spinal Cord Injury or Multiple Sclerosis.
- Subjects with Spinal Cord Injury must have a stable neurological injury at T1 level or
below which occurred at least 6 months prior to Screening.
- Subjects with Multiple Sclerosis must be clinically stable in the investigator's
opinion, with no exacerbation (relapse) of MS for at least 3 months prior to
Screening.
- Subjects must have had an inadequate response after at least 4 weeks of oral
medications used in the treatment of NDO (e.g. anticholinergics, beta-3 agonists)
and/or have intolerable side-effects.
- Routinely performing Clean Intermittent Catheterization (CIC) to ensure adequate
bladder emptying.
- An average of at least two episodes per day of Urinary Incontinence recorded on the
screening bladder diary.
Key Exclusion Criteria:
- Any current condition (other than NDO) that may impact on bladder function.
- Previous or current, tumour or malignancy affecting the spinal column or spinal cord,
or any other unstable cause of SCI.
- Any condition that will prevent cystoscopic treatment administration or CIC usage,
e.g. urethral strictures.
- Current indwelling bladder catheter, or removal of indwelling bladder catheter less
than 4 weeks prior to Screening.
- BTX-A treatment within 9 months prior to Screening for any urological condition (e.g.
detrusor or urethral sphincter treatments).
- Any neuromodulation/electrostimulation usage for urinary symptoms/incontinence within
4 weeks prior to Screening. Any implanted neuromodulation device must be switched off
at least 4 weeks prior to Screening.
We found this trial at
33
sites
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Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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333 South Columbia Street
Chapel Hill, North Carolina 27599
Chapel Hill, North Carolina 27599
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Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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1441 Eastlake Ave
Los Angeles, California 90033
Los Angeles, California 90033
(323) 865-3000
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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1951 Southwest 172nd Avenue
Miramar, Florida 33029
Miramar, Florida 33029
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Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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