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

Astellas

Status and phase

Completed

Phase 3

Conditions

Urinary Bladder, Overactive

Treatments

Drug: solifenacin succinate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00463541

905-UC-007

Details and patient eligibility

About

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).

Full description

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

Enrollment

2,225 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)