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OpenTrials
Completed

NCT Number: NCT00463541

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

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).

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Key information

Conditions

Urinary Bladder, Overactive Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bay Minette, Alabama, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Solifenacin succinate

Drug

oral

Other names: VESIcare (R), YM905

Primary outcomes

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

    Time frame: Weeks 4, 8 and 12

Secondary outcomes

  1. Percentage of patients satisfied with 5mg treatment

    Time frame: Week 12

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

    Time frame: week 12

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study 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

Acronym: VOLT

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Apr 20, 2007
Registry last updated
Sep 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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