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Urinary Bladder, OveractivePhase 3VOLTNCT00463541

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

A Phase 3 study testing solifenacin succinate in people with Urinary Bladder, Overactive, run by Astellas Pharma Inc at 198 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urinary Bladder, Overactive
What is being tested?
solifenacin succinate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,225 participants
Where
198 sitesUnited States
Study dates
Jun 2004to Apr 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • -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)

Trial locations and contacts

198 sites in 1 country.

198 sites in 1 country

United States198 sites

  • Study site

    Albany, Georgia, 31701

  • Study site

    Albany, New York, 12208

  • Study site

    Albuquerque, New Mexico, 87108

  • Study site

    Albuquerque, New Mexico, 87109

  • Study site

    Allentown, Pennsylvania, 18102

  • Study site

    Allentown, Pennsylvania, 18104

  • Study site

    Arkansas City, Kansas, 67005

  • Study site

    Asheboro, North Carolina, 27205

  • Study site

    Atlanta, Georgia, 30342

  • Study site

    Aurora, Colorado, 80012

  • Study site

    Austin, Texas, 78705

  • Study site

    Austin, Texas, 78759

  • Study site

    Avon, Connecticut, 06001

  • Study site

    Bala-Cynwyd, Pennsylvania, 19004

  • Study site

    Baltimore, Maryland, 21212

  • Study site

    Bartlett, Tennessee, 38134

  • Study site

    Battle Creek, Michigan, 49017

  • Study site

    Bay Minette, Alabama, 35607

  • Study site

    Beaver, Pennsylvania, 15009

  • Study site

    Bend, Oregon, 97701

  • Study site

    Bensalem, Pennsylvania, 19020

  • Study site

    Bethel Park, Pennsylvania, 15102

  • Study site

    Beverly Hills, California, 90211

  • Study site

    Birmingham, Alabama, 35205

  • Study site

    Birmingham, Alabama, 35209

  • Study site

    Birmingham, Alabama, 35233

  • Study site

    Brandon, Florida, 33511

  • Study site

    Brooklyn, New York, 11203

  • Study site

    Brooklyn, New York, 11219

  • Study site

    Buena Park, California, 90620

  • Study site

    Camp Hill, Pennsylvania, 17011

  • Study site

    Canton, Ohio, 44708

  • Study site

    Cary, North Carolina, 27511

  • Study site

    Charlotte, North Carolina, 28204

  • Study site

    Charlotte, North Carolina, 28211

  • Study site

    Charlottesville, Virginia, 22908

  • Study site

    Chicago, Illinois, 60612

  • Study site

    Chicago, Illinois, 60628

  • Study site

    Cincinnati, Ohio, 45236

  • Study site

    Cleveland, Ohio, 44113

  • Study site

    Colorado Springs, Colorado, 80909

  • Study site

    Columbus, North Carolina, 28722

  • Study site

    Conyers, Georgia, 30013

  • Study site

    Coral Gables, Florida, 33134

  • Study site

    Coral Springs, Florida, 33065

  • Study site

    Corsicana, Texas, 75110

  • Study site

    Corte Madera, California, 94925

  • Study site

    Culver City, California, 90232

  • Study site

    Dallas, Texas, 75230

  • Study site

    Dallas, Texas, 75231

  • Study site

    Dauphin, Pennsylvania, 17018

  • Study site

    Dearborn, Michigan, 48123

  • Study site

    Decatur, Alabama, 35603

  • Study site

    Decatur, Georgia, 30032

  • Study site

    Delray Beach, Florida, 33444

  • Study site

    Detroit, Michigan, 48201

  • Study site

    Duncansville, Pennsylvania, 16635

  • Study site

    East Orange, New Jersey, 07018

  • Study site

    Elkins Park, Pennsylvania, 19027

  • Study site

    Englewood, New Jersey, 07631

  • Study site

    Evanston, Illinois, 60201

  • Study site

    Fair Lawn, New Jersey, 07410

  • Study site

    Fort Collins, Colorado, 80524

  • Study site

    Fort Myers, Florida, 33908

  • Study site

    Fort Worth, Texas, 76104

  • Study site

    Fresno, California, 93720

  • Study site

    Ft.Lauderdale, Florida, 33308

  • Study site

    Fullerton, California, 92835

  • Study site

    Glen Burnie, Maryland, 21601

  • Study site

    Grand Rapids, Michigan, 49544

  • Study site

    Grand Rapids, Michigan, 49546

  • Study site

    Greeneville, Tennessee, 37745

  • Study site

    Greensboro, North Carolina, 27401

  • Study site

    Greenville, Illinois, 62246

  • Study site

    Gulfport, Mississippi, 39501

  • Study site

    Hampton, Virginia, 23666

  • Study site

    Harrisburg, Pennsylvania, 17110

  • Study site

    Hartford, Connecticut, 06106

  • Study site

    Henderson, Nevada, 89014

  • Study site

    Hollywood, Florida, 33021

  • Study site

    Houston, Texas, 77024

  • Study site

    Houston, Texas, 77074

  • Study site

    Huntington, West Virginia, 25701

  • Study site

    Huntington Beach, California, 92647

  • Study site

    Huntsville, Alabama, 35801

  • Study site

    Independence, Missouri, 64055

  • Study site

    Indianapolis, Indiana, 46237

  • Study site

    Jackson, Mississippi, 39202

  • Study site

    Jackson, Missouri, 63755

  • Study site

    Jacksonville, Florida, 32025

  • Study site

    Johnson City, Tennessee, 37601

  • Study site

    Kalamazoo, Michigan, 49009

  • Study site

    Kansas City, Missouri, 64112

  • Study site

    Lake Success, New York, 11042

  • Study site

    Liberty, Missouri, 64068

  • Study site

    Libertyville, Illinois, 60048

  • Study site

    Little Rock, Arkansas, 72204

  • Study site

    Little Rock, Arkansas, 72205

  • Study site

    Liverpool, New York, 13088

  • Study site

    Long Beach, California, 90806

  • Study site

    Los Angeles, California, 90048

  • Study site

    Manchester, Missouri, 63021

  • Study site

    Marietta, Georgia, 30060

  • Study site

    Mason City, Iowa, 50401

  • Study site

    Mattoon, Illinois, 61938

  • Study site

    McConnelsville, Ohio, 43756

  • Study site

    Mentor, Ohio, 44060

  • Study site

    Merritt Island, Florida, 32952

  • Study site

    Miami, Florida, 33186

  • Study site

    Milford, Massachusetts, 01757

  • Study site

    Mineola, New York, 11501

  • Study site

    Mission Viejo, California, 92692

  • Study site

    Missoula, Montana, 59801

  • Study site

    Modesto, California, 95350

  • Study site

    Mt. Pleasant, South Carolina, 29464

  • Study site

    Murfreesboro, Tennessee, 37130

  • Study site

    Nashville, Tennessee, 37203

  • Study site

    New Brunswick, New Jersey, 08901

  • Study site

    New Orleans, Louisiana, 70115

  • Study site

    New Tazewell, Tennessee, 37825

  • Study site

    New York, New York, 10021

  • Study site

    Newton, Kansas, 67114

  • Study site

    Norman, Oklahoma, 73071

  • Study site

    Oceanside, California, 92056

  • Study site

    Okeechobee, Florida, 34972

  • Study site

    Omaha, Nebraska, 68114

  • Study site

    Omaha, Nebraska, 68134

  • Study site

    Omaha, Nebraska, 68137

  • Study site

    Orange, California, 92868

  • Study site

    Orange, California, 92869

  • Study site

    Orlando, Florida, 32806

  • Study site

    Oro Valley, Arizona, 85739

  • Study site

    Painesville, Ohio, 44077

  • Study site

    Paramount, California, 90723

  • Study site

    Park Ridge, Illinois, 60068

  • Study site

    Pembroke Pines, Florida, 33026

  • Study site

    Pembroke Pines, Florida, 33027

  • Study site

    Pembroke Pines, Florida, 33028

  • Study site

    Perth Amboy, New Jersey, 08861

  • Study site

    Philadelphia, Pennsylvania, 19114

  • Study site

    Philadelphia, Pennsylvania, 19140

  • Study site

    Phoenix, Arizona, 85012

  • Study site

    Phoenix, Arizona, 85051

  • Study site

    Phoenixville, Pennsylvania, 19460

  • Study site

    Pittsburgh, Pennsylvania, 15206

  • Study site

    Plano, Texas, 75093

  • Study site

    Pomona, California, 91767

  • Study site

    Portland, Oregon, 97210

  • Study site

    Poughkeepsie, New York, 12601f

  • Study site

    Princeton, New Jersey, 08540

  • Study site

    Raleigh, North Carolina, 27606

  • Study site

    Raleigh, North Carolina, 27612

  • Study site

    Reno, Nevada, 89511

  • Study site

    Rochester, New York, 14609

  • Study site

    Rochester, New York, 14622

  • Study site

    Rochester, New York, 14642

  • Study site

    Roswell, Georgia, 30076

  • Study site

    Royal Palm Beach, Florida, 33411

  • Study site

    Sacramento, California, 95823

  • Study site

    Saint Clair Shores, Michigan, 48081

  • Study site

    Saint Louis Park, Minnesota, 55416

  • Study site

    Salt Lake City, Utah, 84107

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Bernadino, California, 92404

  • Study site

    San Diego, California, 92108

  • Study site

    Sandy City, Utah, 84094

  • Study site

    Scottsdale, Arizona, 85260

  • Study site

    Seattle, Washington, 98133

  • Study site

    Shawnee, Kansas, 66203

  • Study site

    Shreveport, Louisiana, 71106

  • Study site

    Simpsonville, South Carolina, 29681

  • Study site

    Snellville, Georgia, 30078

  • Study site

    Spokane, Washington, 99204

  • Study site

    Springfield, Missouri, 65804

  • Study site

    St Louis, Missouri, 63117

  • Study site

    St Louis, Missouri, 63141

  • Study site

    Tacoma, Washington, 98450

  • Study site

    Tampa, Florida, 33624

  • Study site

    The Bronx, New York, 10461

  • Study site

    Tomball, Texas, 77375

  • Study site

    Topeka, Kansas, 66614

  • Study site

    Torrance, California, 90505

  • Study site

    Tucson, Arizona, 85712

  • Study site

    Tulsa, Oklahoma, 74104

  • Study site

    Tulsa, Oklahoma, 74146

  • Study site

    Tustin, California, 92780

  • Study site

    Upland, California, 91786

  • Study site

    Vienna, Virginia, 22180

  • Study site

    Vista, California, 92084

  • Study site

    Watertown, Massachusetts, 02472

  • Study site

    Wellington, Florida, 33414

  • Study site

    Wheat Ridge, Colorado, 80033

  • Study site

    Wichita, Kansas, 67207

  • Study site

    Williamsport, Pennsylvania, 17701

  • Study site

    Wilmington, Delaware, 19808

  • Study site

    Woodburn, Oregon, 97071

  • Study site

    Woodstock, Georgia, 30189

  • Study site

    Zanesville, Ohio, 43701

Other trials in United States

About this study

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

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).

Read the detailed description

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

Being tested
solifenacin succinate
Keywords
Urinary Bladder, Overactive, Urgency, VESIcare®, Solifenacin succinate
Medical subject headings
Urinary Bladder, Overactive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • solifenacin succinateDrug

    Also called VESIcare (R), YM905

    oral

Study groups in NCT00463541
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: solifenacin succinate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate the efficacy of 5 and 10mg solifenacin succinate in patients with OAB symptoms

    Measured: Weeks 4, 8 and 12

Secondary outcomes (2)

  1. Percentage of patients satisfied with 5mg treatment

    Measured: Week 12

  2. Percentage of patients obtaining additional benefit with increase to 10mg dose

    Measured: week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2007 (estimated)
  2. Study startJun 2004
  3. Primary completionApr 2005
  4. Study completionApr 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
2,225 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00463541
Sponsor's protocol ID
905-UC-007
Acronym
VOLT
Status last verified
Sep 2014
First submitted
19 Apr 2007
Last updated
18 Sep 2014
Results posted
No
Data monitoring committee
No

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.

    PubMed 18036164

  • 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.

    PubMed 17407639

  • 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.

    PubMed 17213014

  • 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.

    PubMed 17341526

  • 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.

    PubMed 19434385

  • 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.

    PubMed 21293089

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing solifenacin succinate in people with Urinary Bladder, Overactive, run by Astellas Pharma Inc at 198 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 198 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the efficacy of 5 and 10mg solifenacin succinate in patients with OAB symptoms (time frame: Weeks 4, 8 and 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00463541, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2014.

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