Open-label Study of the Efficacy and Safety of VESIcare® in Patients With Overactive Bladder Symptoms (VOLT)

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

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).

Study Overview

• Status: Completed
• Conditions: Urinary Bladder, Overactive
• Intervention / Treatment: Drug: solifenacin succinate

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 2225
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Bay Minette, Alabama, United States, 35607
    • Birmingham, Alabama, United States, 35209
    • Birmingham, Alabama, United States, 35233
    • Birmingham, Alabama, United States, 35205
    • Decatur, Alabama, United States, 35603
    • Huntsville, Alabama, United States, 35801
  • Arizona
    • Oro Valley, Arizona, United States, 85739
    • Phoenix, Arizona, United States, 85012
    • Phoenix, Arizona, United States, 85051
    • Scottsdale, Arizona, United States, 85260
    • Tucson, Arizona, United States, 85712
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
    • Little Rock, Arkansas, United States, 72204
  • California
    • Beverly Hills, California, United States, 90211
    • Buena Park, California, United States, 90620
    • Corte Madera, California, United States, 94925
    • Culver City, California, United States, 90232
    • Fresno, California, United States, 93720
    • Fullerton, California, United States, 92835
    • Huntington Beach, California, United States, 92647
    • Long Beach, California, United States, 90806
    • Los Angeles, California, United States, 90048
    • Mission Viejo, California, United States, 92692
    • Modesto, California, United States, 95350
    • Oceanside, California, United States, 92056
    • Orange, California, United States, 92868
    • Orange, California, United States, 92869
    • Paramount, California, United States, 90723
    • Pomona, California, United States, 91767
    • Sacramento, California, United States, 95823
    • San Bernadino, California, United States, 92404
    • San Diego, California, United States, 92108
    • Torrance, California, United States, 90505
    • Tustin, California, United States, 92780
    • Upland, California, United States, 91786
    • Vista, California, United States, 92084
  • Colorado
    • Aurora, Colorado, United States, 80012
    • Colorado Springs, Colorado, United States, 80909
    • Fort Collins, Colorado, United States, 80524
    • Wheat Ridge, Colorado, United States, 80033
  • Connecticut
    • Avon, Connecticut, United States, 06001
    • Hartford, Connecticut, United States, 06106
  • Delaware
    • Wilmington, Delaware, United States, 19808
  • Florida
    • Brandon, Florida, United States, 33511
    • Coral Gables, Florida, United States, 33134
    • Coral Springs, Florida, United States, 33065
    • Delray Beach, Florida, United States, 33444
    • Fort Myers, Florida, United States, 33908
    • Ft.Lauderdale, Florida, United States, 33308
    • Hollywood, Florida, United States, 33021
    • Jacksonville, Florida, United States, 32025
    • Merritt Island, Florida, United States, 32952
    • Miami, Florida, United States, 33186
    • Okeechobee, Florida, United States, 34972
    • Orlando, Florida, United States, 32806
    • Pembroke Pines, Florida, United States, 33026
    • Pembroke Pines, Florida, United States, 33027
    • Pembroke Pines, Florida, United States, 33028
    • Royal Palm Beach, Florida, United States, 33411
    • Tampa, Florida, United States, 33624
    • Wellington, Florida, United States, 33414
  • Georgia
    • Albany, Georgia, United States, 31701
    • Atlanta, Georgia, United States, 30342
    • Conyers, Georgia, United States, 30013
    • Decatur, Georgia, United States, 30032
    • Marietta, Georgia, United States, 30060
    • Roswell, Georgia, United States, 30076
    • Snellville, Georgia, United States, 30078
    • Woodstock, Georgia, United States, 30189
  • Illinois
    • Chicago, Illinois, United States, 60612
    • Chicago, Illinois, United States, 60628
    • Evanston, Illinois, United States, 60201
    • Greenville, Illinois, United States, 62246
    • Libertyville, Illinois, United States, 60048
    • Mattoon, Illinois, United States, 61938
    • Park Ridge, Illinois, United States, 60068
  • Indiana
    • Indianapolis, Indiana, United States, 46237
  • Iowa
    • Mason City, Iowa, United States, 50401
  • Kansas
    • Arkansas City, Kansas, United States, 67005
    • Newton, Kansas, United States, 67114
    • Shawnee, Kansas, United States, 66203
    • Topeka, Kansas, United States, 66614
    • Wichita, Kansas, United States, 67207
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
    • Shreveport, Louisiana, United States, 71106
  • Maryland
    • Baltimore, Maryland, United States, 21212
    • Glen Burnie, Maryland, United States, 21601
  • Massachusetts
    • Milford, Massachusetts, United States, 01757
    • Watertown, Massachusetts, United States, 02472
  • Michigan
    • Battle Creek, Michigan, United States, 49017
    • Dearborn, Michigan, United States, 48123
    • Detroit, Michigan, United States, 48201
    • Grand Rapids, Michigan, United States, 49546
    • Grand Rapids, Michigan, United States, 49544
    • Kalamazoo, Michigan, United States, 49009
    • St. Clair Shores, Michigan, United States, 48081
  • Minnesota
    • St. Louis Park, Minnesota, United States, 55416
  • Mississippi
    • Gulfport, Mississippi, United States, 39501
    • Jackson, Mississippi, United States, 39202
  • Missouri
    • Independence, Missouri, United States, 64055
    • Jackson, Missouri, United States, 63755
    • Kansas City, Missouri, United States, 64112
    • Liberty, Missouri, United States, 64068
    • Manchester, Missouri, United States, 63021
    • Springfield, Missouri, United States, 65804
    • St. Louis, Missouri, United States, 63141
    • St. Louis, Missouri, United States, 63117
  • Montana
    • Missoula, Montana, United States, 59801
  • Nebraska
    • Omaha, Nebraska, United States, 68114
    • Omaha, Nebraska, United States, 68134
    • Omaha, Nebraska, United States, 68137
  • Nevada
    • Henderson, Nevada, United States, 89014
    • Reno, Nevada, United States, 89511
  • New Jersey
    • East Orange, New Jersey, United States, 07018
    • Englewood, New Jersey, United States, 07631
    • Fair Lawn, New Jersey, United States, 07410
    • New Brunswick, New Jersey, United States, 08901
    • Perth Amboy, New Jersey, United States, 08861
    • Princeton, New Jersey, United States, 08540
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
    • Albuquerque, New Mexico, United States, 87108
  • New York
    • Albany, New York, United States, 12208
    • Bronx, New York, United States, 10461
    • Brooklyn, New York, United States, 11203
    • Brooklyn, New York, United States, 11219
    • Lake Success, New York, United States, 11042
    • Liverpool, New York, United States, 13088
    • Mineola, New York, United States, 11501
    • New York, New York, United States, 10021
    • Poughkeepsie, New York, United States, 12601f
    • Rochester, New York, United States, 14642
    • Rochester, New York, United States, 14609
    • Rochester, New York, United States, 14622
  • North Carolina
    • Asheboro, North Carolina, United States, 27205
    • Cary, North Carolina, United States, 27511
    • Charlotte, North Carolina, United States, 28204
    • Charlotte, North Carolina, United States, 28211
    • Columbus, North Carolina, United States, 28722
    • Greensboro, North Carolina, United States, 27401
    • Raleigh, North Carolina, United States, 27612
    • Raleigh, North Carolina, United States, 27606
  • Ohio
    • Canton, Ohio, United States, 44708
    • Cincinnati, Ohio, United States, 45236
    • Cleveland, Ohio, United States, 44113
    • McConnelsville, Ohio, United States, 43756
    • Mentor, Ohio, United States, 44060
    • Painesville, Ohio, United States, 44077
    • Zanesville, Ohio, United States, 43701
  • Oklahoma
    • Norman, Oklahoma, United States, 73071
    • Tulsa, Oklahoma, United States, 74104
    • Tulsa, Oklahoma, United States, 74146
  • Oregon
    • Bend, Oregon, United States, 97701
    • Portland, Oregon, United States, 97210
    • Woodburn, Oregon, United States, 97071
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18102
    • Allentown, Pennsylvania, United States, 18104
    • Bala Cynwyd, Pennsylvania, United States, 19004
    • Beaver, Pennsylvania, United States, 15009
    • Bensalem, Pennsylvania, United States, 19020
    • Bethel Park, Pennsylvania, United States, 15102
    • Camp Hill, Pennsylvania, United States, 17011
    • Dauphin, Pennsylvania, United States, 17018
    • Duncansville, Pennsylvania, United States, 16635
    • Elkins Park, Pennsylvania, United States, 19027
    • Harrisburg, Pennsylvania, United States, 17110
    • Philadelphia, Pennsylvania, United States, 19140
    • Philadelphia, Pennsylvania, United States, 19114
    • Phoenixville, Pennsylvania, United States, 19460
    • Pittsburgh, Pennsylvania, United States, 15206
    • Williamsport, Pennsylvania, United States, 17701
  • South Carolina
    • Mt. Pleasant, South Carolina, United States, 29464
    • Simpsonville, South Carolina, United States, 29681
  • Tennessee
    • Bartlett, Tennessee, United States, 38134
    • Greeneville, Tennessee, United States, 37745
    • Johnson City, Tennessee, United States, 37601
    • Murfreesboro, Tennessee, United States, 37130
    • Nashville, Tennessee, United States, 37203
    • New Tazewell, Tennessee, United States, 37825
  • Texas
    • Austin, Texas, United States, 78705
    • Austin, Texas, United States, 78759
    • Corsicana, Texas, United States, 75110
    • Dallas, Texas, United States, 75231
    • Dallas, Texas, United States, 75230
    • Fort Worth, Texas, United States, 76104
    • Houston, Texas, United States, 77024
    • Houston, Texas, United States, 77074
    • Plano, Texas, United States, 75093
    • San Antonio, Texas, United States, 78229
    • Tomball, Texas, United States, 77375
  • Utah
    • Salt Lake City, Utah, United States, 84107
    • Sandy, Utah, United States, 84094
  • Virginia
    • Charlottesville, Virginia, United States, 22908
    • Hampton, Virginia, United States, 23666
    • Vienna, Virginia, United States, 22180
  • Washington
    • Seattle, Washington, United States, 98133
    • Spokane, Washington, United States, 99204
    • Tacoma, Washington, United States, 98450
  • West Virginia
    • Huntington, West Virginia, United States, 25701

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: solifenacin succinate; oral; Other Names: YM905; VESIcare (R)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To evaluate the efficacy of 5 and 10mg solifenacin succinate in patients with OAB symptoms	Weeks 4, 8 and 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients satisfied with 5mg treatment	Week 12
Percentage of patients obtaining additional benefit with increase to 10mg dose	week 12

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• Link to Results on JAPIC - enter 140593 in the JapicCTI-RNo. field

Study record dates

Study Major Dates

• Study Start: June 1, 2004
• Primary Completion (Actual): April 1, 2005
• Study Completion (Actual): April 1, 2005

Study Registration Dates

• First Submitted: April 19, 2007
• First Submitted That Met QC Criteria: April 19, 2007
• First Posted (Estimate): April 20, 2007

Study Record Updates

• Last Update Posted (Estimate): September 18, 2014
• Last Update Submitted That Met QC Criteria: September 17, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Urgency; Solifenacin succinate; Urinary Bladder, Overactive; VESIcare®
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Solifenacin Succinate
• Other Study ID Numbers: 905-UC-007