This is a clinical trial for
Patients with Urinary Incontinence, who have Multiple Sclerosis or Spinal Cord Injury
People with certain conditions such as Multiple Sclerosis (MS) and Spinal Cord Injury (SCI) may experience urinary incontinence, or involuntary urine loss, as a result of the bladder muscle not relaxing and contracting too often. Oral medications are available but do not work for all patients. The purpose of this study is to examine whether Dysport®, which is already approved for other conditions, can reduce urinary incontinence in patients with MS or SCI, for whom oral medications have not worked well. The
This is a phase 3 trial. What does this mean? A phase 3 trial means that the study drug has been taken by other participants under the supervision of medical professionals.
There will be 408 participants in this trial, at 32 sites around the world
- be between 18 – 80 years old
- have Multiple Sclerosis (MS) or Spinal Cord Injury (SCI)
- have urinary incontinence due to Neurogenic Detrusor Overactivity (NDO, or overactive bladder) as a result of MS or SCI
- have had inadequate response to oral medications for urinary incontinence
- be routinely performing clean intermittent catheterization (CIC, or routine use of a catheter to empty urine from the bladder)
Participants must not:
- have had prior surgery for Neurogenic Detrusor Overactivity (NDO)
This trial is 104 weeks long, requiring 7 visits and 0 overnight stays.
A placebo isn’t being used for this trial.
The sponsor of this trial is Ipsen.
The results of this trial will not be published.
Patients will not be able to continue taking the medication after the trial.
This study will take place across 2 countries
32 sites will be participating.
- Mountlake Terrace, Integrity Medical Research, LLC, No. 121, 98043
- Plainview, Advanced Urology Centers of New York, Suite 101, 11783
- New York, Weill Cornell Medical College, 12th Floor, 10065
- New York, New York University Langone Medical Center and School of Medicine, 10016
- Bronx, Montefiore Medical Center, 10461-2732
- Owings Mill, Chesapeake Urology Associates, PA, Suite 220, 21117
- Cleveland, Louis Stokes Cleveland Veterans Affairs Medical Center, 44106
- Cleveland, Cleveland Clinic, 44195
- 96 Jonathan Lucas Street, Medical University of South Carolina (MUSC), 29425
- Nashville, Vanderbilt University Medical Center, A-1302 MCN, 37232
- Farmington, Women's Healthy Specialty Care, 06032
- Charlotte, Levine Cancer Institute, 28207
- Chapel Hill, University of North Carolina School of Medicine, 27599
- Philadelphia, Thomas Jefferson University Hospital, 11th Floor, 19107
- Lancaster, Lancaster Urology, Suite 200, 17601
- Shreveport, Regional Urology, LLC, 71106
- Morristown, Weill Cornell Medical College, 07960
- Voorhees, Delaware Valley Urology,IIC, Suite F, 08043
- Aurora, University of Colorado Denver, 80045
- Tucson, Urological Associates of Southern Arizona, P.C., 85715
- W Des Moines, The Iowa Clinic, PC, 50266
- Albuquerque, Urology Group of New Mexico, PC, 87109
- Dallas, Urology Clinics of North Texas, Suite 700, 75231
- Houston, Houston Methodist Hospital, R12-107, 77030
- Long Beach, Atlantic Urology Medical Group, No. 414, 90806
- Los Angeles, USC Norris Comprehensive Cancer Center, 90089
- Sacramento, UC Davis Medical Center, Suite 3500, 95817
- Birmingham, UAB School of Medicine Spain Rehabilitation Center (SRC), FOT 1105, 35294
- Plymouth, Metro Urology, Suite 530, 55441
- Ann Arbor, University of Michigan Hospital, 32849
- Vancouver, UBC Hospital - Koerner Pavilion, Blusson ICORD Centre , V6T 2B5
- Toronto, Sunnybrook Health Sciences Centre, M4N 3M5
Frequently asked questions
What are clinical trials?
Clinical trials are research studies to determine whether investigational drugs or treatments are safe and effective for humans. All new investigational medications and devices must undergo several clinical trials, often involving thousands of people.
Can I quit a trial?
You can quit a clinical trial at any time and you do not have to give a reason. There is no charge or penalty for quitting.
Why participate in a clinical trial?
You will have access to new investigational treatments that would be available to the general public only upon approval. You will also receive study-related medical care and attention from clinical trial staff at research facilities. Clinical trials offer hope for many people and an opportunity to help researchers find better treatments for others in the future.
What are the benefits and risks of clinical trials?
You may or may not receive direct clinical benefit from this study but your participation will provide important information to help researchers learn more about the condition and possibly develop better treatments for future patients.
Is my information safe?
The Study Information is used only for research purposes and will be kept confidential within the limits of the law of your country. If the results of this study are published or presented in a meeting, you will not be named and nobody will be able to tell that you were in the study from the publication or presentation.
Any other questions?
If you would like to speak to someone regarding this trial fill in this quick questionnaire. If you are eligible someone from the research team will contact you by phone and explain everything in more detail.
You are under no obligation to proceed even if you fill it in and can drop out at any point.