Open-Label Study of the Efficacy and Safety of VESIcare® in Patients With Overactive Bladder Symptoms

Condition(s) targeted: Urinary Bladder, Overactive

Intervention: VESIcare®, solifenacin succinate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Use Central Contact, Study Director, Affiliation: Astellas Pharma US, Inc.

To evaluate the safety and efficacy of solifenacin succinate in subjects with overactive bladder symptoms (urgency, with or without urge incontinence, usually with frequency and nocturia).

Official title: An Open-Label Study of the Efficacy and Safety of 5 and 10mg VESIcare® (Solifenacin Succinate) in Patients With Overactive Bladder Symptoms VOLT: VESIcare® Open-Label Trial

Study design: Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study

Primary outcome: To evaluate the efficacy of 5 and 10mg solifenacin succinate in patients with OAB symptoms (urgency, with or without urge incontinence, usually with frequency and nocturia).

Secondary outcome:

Assess: most bothersome OAB symptom at baseline; % satisfied with 5mg treatment; % obtain additional benefit with increase to 10mg dose

satisfaction with treatment for patients completing 12 weeks of treatment; safety and tolerability of 5 and 10mg Vesicare

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: Symptoms of OAB (urgency, with or without urge incontinence, usually with frequency and nocturia) for ≥3 or more months. Patients may be included if they are on another OAB medication; however, patients must washout from other OAB medications for at least 7 days prior to receiving solifenacin succinate. Previous non-drug treatment of OAB is allowed if it has been established at least 4 weeks prior to study entry and is continued throughout the study. Exclusion Criteria:

- Significant stress incontinence or mixed stress/urge incontinence where stress is the

predominant factor Evidence of urinary tract infection; chronic inflammation such as interstitial cystitis and bladder stones Clinically significant outflow obstruction (benign prostatic hyperplasia)

Birmingham, Alabama, United States

Huntsville, Alabama, United States

Decatur, Alabama, United States

Bay Minette, Alabama, United States

Phoenix, Arizona, United States

Oro Valley, Arizona, United States

Tucson, Arizona, United States

Scottsdale, Arizona, United States

Little Rock, Arkansas, United States

Oceanside, California, United States

Fullerton, California, United States

Upland, California, United States

Los Angeles, California, United States

Buena Park, California, United States

Long Beach, California, United States

Paramount, California, United States

Huntington Beach, California, United States

Beverly Hills, California, United States

Pomona, California, United States

Aurora, California, United States

San Diego, California, United States

San Bernadino, California, United States

Culver City, California, United States

Orange, California, United States

Corte Madera, California, United States

Modesto, California, United States

Tustin, California, United States

Vista, California, United States

Torrance, California, United States

Mission Viejo, California, United States

Fresno, California, United States

Sacramento, California, United States

Colorado Springs, Colorado, United States

Fort Collins, Colorado, United States

Wheat Ridge, Colorado, United States

Hartford, Connecticut, United States

Avon, Connecticut, United States

Wilmington, Delaware, United States

Pembroke Pines, Florida, United States

Merritt Island, Florida, United States

Tampa, Florida, United States

Delray Beach, Florida, United States

Miami, Florida, United States

Coral Springs, Florida, United States

Brandon, Florida, United States

Orlando, Florida, United States

Hollywood, Florida, United States

Fort Myers, Florida, United States

Wellington, Florida, United States

Jacksonville, Florida, United States

Coral Gables, Florida, United States

Ft.Lauderdale, Florida, United States

Okeechobee, Florida, United States

Royal Palm Beach, Florida, United States

Conyers, Georgia, United States

Snellville, Georgia, United States

Albany, Georgia, United States

Marietta, Georgia, United States

Atlanta, Georgia, United States

Decatur, Georgia, United States

Roswell, Georgia, United States

Woodstock, Georgia, United States

Chicago, Illinois, United States

Mattoon, Illinois, United States

Greenville, Illinois, United States

Park Ridge, Illinois, United States

Libertyville, Illinois, United States

Evanston, Illinois, United States

Indianapolis, Indiana, United States

Mason City, Iowa, United States

Shawnee, Kansas, United States

Newton, Kansas, United States

Wichita, Kansas, United States

Arkansas City, Kansas, United States

Topeka, Kansas, United States

Shreveport, Louisiana, United States

New Orleans, Louisiana, United States

Glen Burnie, Maryland, United States

Baltimore, Maryland, United States

Watertown, Massachusetts, United States

Milford, Massachusetts, United States

Battle Creek, Michigan, United States

St. Clair Shores, Michigan, United States

Dearborn, Michigan, United States

Kalamazoo, Michigan, United States

Detroit, Michigan, United States

Grand Rapids, Michigan, United States

St. Louis Park, Minnesota, United States

Jackson, Mississippi, United States

Gulfport, Mississippi, United States

St. Louis, Missouri, United States

Liberty, Missouri, United States

Springfield, Missouri, United States

Manchester, Missouri, United States

Jackson, Missouri, United States

Kansas City, Missouri, United States

Independence, Missouri, United States

Missoula, Montana, United States

Omaha, Nebraska, United States

Reno, Nevada, United States

Henderson, Nevada, United States

East Orange, New Jersey, United States

New Brunswick, New Jersey, United States

Fair Lawn, New Jersey, United States

Perth Amboy, New Jersey, United States

Hamilton, New Jersey, United States

Englewood, New Jersey, United States

Albuquerque, New Mexico, United States

Brooklyn, New York, United States

Rochester, New York, United States

Mineola, New York, United States

Poughkeepsie, New York, United States

New York, New York, United States

Bronx, New York, United States

Lake Success, New York, United States

Liverpool, New York, United States

Albany, New York, United States

Raleigh, North Carolina, United States

Charlotte, North Carolina, United States

Columbus, North Carolina, United States

Asheboro, North Carolina, United States

Greensboro, North Carolina, United States

Cary, North Carolina, United States

Cleveland, Ohio, United States

Zanesville, Ohio, United States

McConnelsville, Ohio, United States

Painesville, Ohio, United States

Mentor, Ohio, United States

Canton, Ohio, United States

Cincinnati, Ohio, United States

Norman, Oklahoma, United States

Tulsa, Oklahoma, United States

Portland, Oregon, United States

Bend, Oregon, United States

Woodburn, Oregon, United States

Bala Cynwyd, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Dauphin, Pennsylvania, United States

Bethel Park, Pennsylvania, United States

Allentown, Pennsylvania, United States

Beaver, Pennsylvania, United States

Camp Hill, Pennsylvania, United States

Duncansville, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Williamsport, Pennsylvania, United States

Harrisburg, Pennsylvania, United States

Elkins Park, Pennsylvania, United States

Bensalem, Pennsylvania, United States

Phoenixville, Pennsylvania, United States

Simpsonville, South Carolina, United States

Mt. Pleasant, South Carolina, United States

Greeneville, Tennessee, United States

New Tazewell, Tennessee, United States

Johnson City, Tennessee, United States

Nashville, Tennessee, United States

Murfreesboro, Tennessee, United States

Bartlett, Tennessee, United States

Fort Worth, Texas, United States

Dallas, Texas, United States

Plano, Texas, United States

Austin, Texas, United States

Houston, Texas, United States

Corsicana, Texas, United States

San Antonio, Texas, United States

Tomball, Texas, United States

Sandy, Utah, United States

Salt Lake City, Utah, United States

Hampton, Virginia, United States

Vienna, Virginia, United States

Charlottesville, Virginia, United States

Mountlake Terrace, Washington, United States

Spokane, Washington, United States

Tacoma, Washington, United States

Huntington, West Virginia, United States

Starting date: June 2004
Last updated: April 19, 2007