Phase 4 Completed N=132 Randomized Triple-blind Treatment

Study to Compare the Safety and Efficacy of Solifenacin With Oxybutynin for the Treatment of Overactive Bladder (VECTOR)

Overactive Bladder

Source: ClinicalTrials.gov NCT00431041 ↗

Enrolled (actual)

132

Serious AEs

2.3%

Results posted

Jan 2010

Primary outcomePrimary: The Number of Subjects Reporting Incidence of Dry Mouth as an Adverse Event — 24; 53 participants — p=<0.0001

Summary

The purpose of this study is to compare the safety and efficacy of solifenacin with oxybutynin immediate-release (IR) for the treatment of overactive bladder (OAB).

Outcome Measures

Outcome	Result	p-value
PRIMARY The Number of Subjects Reporting Incidence of Dry Mouth as an Adverse Event	24; 53	<0.0001 sig
PRIMARY The Severity of Dry Mouth Reported as an Adverse Event	18; 16; 3; 22; 3; 15	0.0010 sig
SECONDARY Change From Baseline in Micturition Frequency as Reported in Subject 3-day Diary	-2.3; -3.1; 12.4; 12.5; 9.9; 9.0	—
SECONDARY Change From Baseline in Urgency Episodes as Reported in Subject 3-day Diary	-2.65; -3.70; 6.3; 6.6; 3.8; 2.1	—

Eligibility Criteria

Inclusion Criteria

Adults 18 years and older.
Overactive bladder symptoms for greater than or equal to 3 months and as documented in a 3-day patient diary following screening and preceding baseline visit: > 1 urge episodes/24 hours (average); greater than or equal to 8 micturitions/24 hours (average)

Exclusion Criteria

Urinary tract infection, chronic inflammation such as interstitial cystitis and bladder stones
Clinically significant outflow obstruction
Uncontrolled narrow angle glaucoma, urinary, or gastric retention
Severe renal or hepatic impairment
Chronic severe constipation or history of diagnosed GI obstructive disease
Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor
Diagnosis or history of neurogenic bladder
History of bladder or pelvic cancer

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00431041). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.