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

This study has been completed.
Information provided by (Responsible Party):
Astellas Pharma Inc Identifier:
First received: April 19, 2007
Last updated: September 17, 2014
Last verified: September 2014
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).

Condition Intervention Phase
Urinary Bladder, Overactive Drug: solifenacin succinate Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • To evaluate the efficacy of 5 and 10mg solifenacin succinate in patients with OAB symptoms [ Time Frame: Weeks 4, 8 and 12 ]

Secondary Outcome Measures:
  • Percentage of patients satisfied with 5mg treatment [ Time Frame: Week 12 ]
  • Percentage of patients obtaining additional benefit with increase to 10mg dose [ Time Frame: week 12 ]

Enrollment: 2225
Study Start Date: June 2004
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: solifenacin succinate
Other Names:
  • VESIcare (R)
  • YM905

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00463541

  Show 198 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Study Director: Use Central Contact Astellas Pharma US, Inc.
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Astellas Pharma Inc Identifier: NCT00463541     History of Changes
Other Study ID Numbers: 905-UC-007
Study First Received: April 19, 2007
Last Updated: September 17, 2014

Keywords provided by Astellas Pharma Inc:
Urinary Bladder, Overactive
Solifenacin succinate

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Solifenacin Succinate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents processed this record on September 21, 2017