Clinical trial NCT00463541: Open-label Study of the Efficacy and Safety of VESIcare® in Patients With Overactive Bladder Symptoms
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Bladder, Overactive
Keywords: Urinary Bladder, Overactive
Urgency
VESIcare®
Solifenacin succinate
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2007-04-20
Enrollment: 2225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: Study included a 24 week extension that did not occur due to FDA approval of the product.

Eligibility 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)

Primary outcomes:
measure: To evaluate the efficacy of 5 and 10mg solifenacin succinate in patients with OAB symptoms
timeFrame: Weeks 4, 8 and 12
Secondary outcomes:
measure: Percentage of patients satisfied with 5mg treatment
timeFrame: Week 12
measure: Percentage of patients obtaining additional benefit with increase to 10mg dose
timeFrame: week 12
Other outcomes:
Locations:
city: Bay Minette
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Decatur
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Oro Valley
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Beverly Hills
country: United States
state: California
city: Buena Park
country: United States
state: California
city: Corte Madera
country: United States
state: California
city: Culver City
country: United States
state: California
city: Fresno
country: United States
state: California
city: Fullerton
country: United States
state: California
city: Huntington Beach
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Mission Viejo
country: United States
state: California
city: Modesto
country: United States
state: California
city: Oceanside
country: United States
state: California
city: Orange
country: United States
state: California
city: Orange
country: United States
state: California
city: Paramount
country: United States
state: California
city: Pomona
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Bernadino
country: United States
state: California
city: San Diego
country: United States
state: California
city: Torrance
country: United States
state: California
city: Tustin
country: United States
state: California
city: Upland
country: United States
state: California
city: Vista
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Colorado Springs
country: United States
state: Colorado
city: Fort Collins
country: United States
state: Colorado
city: Wheat Ridge
country: United States
state: Colorado
city: Avon
country: United States
state: Connecticut
city: Hartford
country: United States
state: Connecticut
city: Wilmington
country: United States
state: Delaware
city: Brandon
country: United States
state: Florida
city: Coral Gables
country: United States
state: Florida
city: Coral Springs
country: United States
state: Florida
city: Delray Beach
country: United States
state: Florida
city: Fort Myers
country: United States
state: Florida
city: Ft.Lauderdale
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Merritt Island
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Okeechobee
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Royal Palm Beach
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Wellington
country: United States
state: Florida
city: Albany
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Conyers
country: United States
state: Georgia
city: Decatur
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Roswell
country: United States
state: Georgia
city: Snellville
country: United States
state: Georgia
city: Woodstock
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Evanston
country: United States
state: Illinois
city: Greenville
country: United States
state: Illinois
city: Libertyville
country: United States
state: Illinois
city: Mattoon
country: United States
state: Illinois
city: Park Ridge
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Mason City
country: United States
state: Iowa
city: Arkansas City
country: United States
state: Kansas
city: Newton
country: United States
state: Kansas
city: Shawnee
country: United States
state: Kansas
city: Topeka
country: United States
state: Kansas
city: Wichita
country: United States
state: Kansas
city: New Orleans
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Glen Burnie
country: United States
state: Maryland
city: Milford
country: United States
state: Massachusetts
city: Watertown
country: United States
state: Massachusetts
city: Battle Creek
country: United States
state: Michigan
city: Dearborn
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: Grand Rapids
country: United States
state: Michigan
city: Grand Rapids
country: United States
state: Michigan
city: Kalamazoo
country: United States
state: Michigan
city: St. Clair Shores
country: United States
state: Michigan
city: St. Louis Park
country: United States
state: Minnesota
city: Gulfport
country: United States
state: Mississippi
city: Jackson
country: United States
state: Mississippi
city: Independence
country: United States
state: Missouri
city: Jackson
country: United States
state: Missouri
city: Kansas City
country: United States
state: Missouri
city: Liberty
country: United States
state: Missouri
city: Manchester
country: United States
state: Missouri
city: Springfield
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Missoula
country: United States
state: Montana
city: Omaha
country: United States
state: Nebraska
city: Omaha
country: United States
state: Nebraska
city: Omaha
country: United States
state: Nebraska
city: Henderson
country: United States
state: Nevada
city: Reno
country: United States
state: Nevada
city: East Orange
country: United States
state: New Jersey
city: Englewood
country: United States
state: New Jersey
city: Fair Lawn
country: United States
state: New Jersey
city: New Brunswick
country: United States
state: New Jersey
city: Perth Amboy
country: United States
state: New Jersey
city: Princeton
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Albuquerque
country: United States
state: New Mexico
city: Albany
country: United States
state: New York
city: Bronx
country: United States
state: New York
city: Brooklyn
country: United States
state: New York
city: Brooklyn
country: United States
state: New York
city: Lake Success
country: United States
state: New York
city: Liverpool
country: United States
state: New York
city: Mineola
country: United States
state: New York
city: New York
country: United States
state: New York
city: Poughkeepsie
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Asheboro
country: United States
state: North Carolina
city: Cary
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Columbus
country: United States
state: North Carolina
city: Greensboro
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Canton
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: McConnelsville
country: United States
state: Ohio
city: Mentor
country: United States
state: Ohio
city: Painesville
country: United States
state: Ohio
city: Zanesville
country: United States
state: Ohio
city: Norman
country: United States
state: Oklahoma
city: Tulsa
country: United States
state: Oklahoma
city: Tulsa
country: United States
state: Oklahoma
city: Bend
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Woodburn
country: United States
state: Oregon
city: Allentown
country: United States
state: Pennsylvania
city: Allentown
country: United States
state: Pennsylvania
city: Bala Cynwyd
country: United States
state: Pennsylvania
city: Beaver
country: United States
state: Pennsylvania
city: Bensalem
country: United States
state: Pennsylvania
city: Bethel Park
country: United States
state: Pennsylvania
city: Camp Hill
country: United States
state: Pennsylvania
city: Dauphin
country: United States
state: Pennsylvania
city: Duncansville
country: United States
state: Pennsylvania
city: Elkins Park
country: United States
state: Pennsylvania
city: Harrisburg
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Phoenixville
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Williamsport
country: United States
state: Pennsylvania
city: Mt. Pleasant
country: United States
state: South Carolina
city: Simpsonville
country: United States
state: South Carolina
city: Bartlett
country: United States
state: Tennessee
city: Greeneville
country: United States
state: Tennessee
city: Johnson City
country: United States
state: Tennessee
city: Murfreesboro
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: New Tazewell
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Corsicana
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Tomball
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Sandy
country: United States
state: Utah
city: Charlottesville
country: United States
state: Virginia
city: Hampton
country: United States
state: Virginia
city: Vienna
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Tacoma
country: United States
state: Washington
city: Huntington
country: United States
state: West Virginia
Study officials:
affiliation: Astellas Pharma US, Inc.
name: Use Central Contact
role: STUDY_DIRECTOR
References:
citation: Capo' JP Jr, Laramee C, Lucente V, Fakhoury A, Forero-Schwanhaeuser S. Solifenacin treatment for overactive bladder in Hispanic patients: patient-reported symptom bother and quality of life outcomes from the VESIcare Open-Label Trial. Int J Clin Pract. 2008 Jan;62(1):39-46. doi: 10.1111/j.1742-1241.2007.01644.x. Epub 2007 Nov 23.
citation: Mallett V, Burks D, Garely AD, Smith N. Solifenacin treatment for overactive bladder in black patients: patient-reported symptom bother and health-related quality of life outcomes. Curr Med Res Opin. 2007 Apr;23(4):821-31. doi: 10.1185/030079907x178847.
citation: Garely AD, Kaufman JM, Sand PK, Smith N, Andoh M. Symptom bother and health-related quality of life outcomes following solifenacin treatment for overactive bladder: the VESIcare Open-Label Trial (VOLT). Clin Ther. 2006 Nov;28(11):1935-46. doi: 10.1016/j.clinthera.2006.11.010.
citation: Garely AD, Lucente V, Vapnek J, Smith N. Solifenacin for overactive bladder with incontinence: symptom bother and health-related quality of life outcomes. Ann Pharmacother. 2007 Mar;41(3):391-8. doi: 10.1345/aph.1H581. Epub 2007 Mar 6.
citation: Sand PK, Steers WD, Dmochowski R, Andoh M, Forero-Schwanhaeuser S. Patient-reported most bothersome symptoms in OAB: post hoc analysis of data from a large, open-label trial of solifenacin. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Jun;20(6):667-75. doi: 10.1007/s00192-009-0840-y. Epub 2009 Mar 10.
citation: Capo' JP, Lucente V, Forero-Schwanhaeuser S, He W. Efficacy and tolerability of solifenacin in patients aged >/= 65 years with overactive bladder: post-hoc analysis of 2 open-label studies. Postgrad Med. 2011 Jan;123(1):94-104. doi: 10.3810/pgm.2011.01.2250.