MS Trial Alert: Investigators Recruiting People with MS for Study of New Investigational Dosage of A - National Multiple Sclerosis Society

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MS Trial Alert: Investigators Recruiting People with MS for Study of New Investigational Dosage of Approved Medication for Urinary Incontinence

December 17, 2012

Summary: Investigators at sites worldwide are recruiting 184 people for a study of a new investigational dosage of an approved medication, which is injected into the bladder muscle to treat urinary incontinence in people with MS. The study is sponsored by Allergan, Inc.

Rationale: Bladder dysfunction occurs when MS lesions block or delay transmission of nerve signals in areas of the central nervous system that control the bladder and urinary sphincter. The result can be a “spastic” bladder that is unable to hold the normal amount of urine and causes uncontrolled urinary leakage, or  a bladder that does not empty properly and retains some urine in it.. Left untreated, bladder dysfunction also could cause emotional and personal hygiene problems that can interfere with normal activities of living and socialization.

There are several treatment options available to help people manage bladder dysfunction, including pelvic floor exercises; anticholinergic medications (which cause the strength of the brain’s signal for the bladder to squeeze to be reduced); electrostimulation/neuromodulators (an implanted device that delivers an electrical pulse to facilitate communication between the brain and bladder); and injectable medication (botulinum toxin), which works by reducing the contraction of muscles by blocking nerve impulses.

Eligibility and Details: Participants are people aged 18 or older with all types of MS who have urinary incontinence not adequately controlled by standard medication. For more details about enrollment criteria, please visit the study Web site listed below. The study team will tell participants the name of the investigational medication during the informed consent process.

Participants will be randomly assigned to receive the active medication or inactive placebo, injected into the bladder muscle. Injection of the bladder muscle is performed using cystoscopy, a procedure that allows a doctor to visualize the interior of the bladder. Cystoscopy may require general anesthesia.

The primary outcome of the study is the number of urinary incontinence episodes, along with secondary outcomes including bladder capacity and quality of life.

From week 12 onwards, participants can request a second injection whether they received the active medication or placebo in the first injection. Everyone who has a second injection will receive the active medication and will be followed for another 12 weeks.  Those who do not receive a second injection will be followed until week 52.

Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please visit the study Web site at: http://www.DIGNITY2study.com/.

Sites are currently enrolling in the cities listed below:
  • Victoria, BC
  • Birmingham, AL
  • Laguna Hills, CA
  • Farmington, CT
  • Miramar, FL
  • Sarasota, FL
  • West Des Moines, IA
  • Evanston, IL
  • Winfield, IL
  • Indianapolis, IN
  • Newburgh, IN
  • Shreveport, LA
  • Annapolis, MD
  • Plymouth, MN
  • Garden City, NY
  • New York, NY
  • Plainview, NY
  • Poughkeepsie, NY
  • Houston, TX
  • Nashville, TN
  • Richmond, VA
  • Mount Lake Terrace, WA
Download a brochure that discusses issues to think about when considering enrolling in an MS clinical trial (PDF).

About Multiple Sclerosis

Multiple sclerosis, an unpredictable, often disabling disease of the central nervous system, interrupts the flow of information within the brain, and between the brain and body. Symptoms range from numbness and tingling to blindness and paralysis. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are moving us closer to a world free of MS. Most people with MS are diagnosed between the ages of 20 and 50, with at least two to three times more women than men being diagnosed with the disease. MS affects more than 2.3 million people worldwide.

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