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

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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).


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
Plainview, New York 11803
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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333 South Columbia Street
Chapel Hill, North Carolina 27599
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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1211 Medical Center Dr
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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Sacramento, California 95814
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Albuquerque, New Mexico 87109
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Ann Arbor, Michigan 48109
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13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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Birmingham, AL
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41 Burlington Mall Road
Burlington, Vermont 01805
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Charleston, South Carolina 29425
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Charlotte, North Carolina 28211
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Dallas, Texas 75231
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407 East 61st Street
Denville, New Jersey 07834
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Farmington, Connecticut 06032
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6550 Fannin St
Houston, Texas 77030
(713) 790-3311
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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Lancaster, Pennsylvania 17604
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Long Beach, California
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1441 Eastlake Ave
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
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Mountlake Terrace, Washington 98043
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Owings Mills, Maryland 21117
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111 S 11th St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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Sherbrooke, 02114
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Virginia Beach, Virginia 23462
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Voorhees, New Jersey 08043
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West Des Moines, Iowa 50266
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