Phase 4 N=768 Randomized Quadruple-blind Treatment

Study of VESIcare® In Overactive Bladder (OAB) Subjects to Evaluate Symptom Bother and Health Related Quality of Life

Urinary Bladder, Overactive

Bottom Line

View on ClinicalTrials.gov: NCT00573508 ↗

Enrolled (actual)

768

Serious AEs

1.2%

Results posted

Oct 2010

Primary outcome: Primary: Change From Baseline to End of Treatment in Overactive Bladder Questionnairre (OAB-q) Symptom Bother Score — 57.9; 58.2; 37.5; 28.3 OAB-q Score — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Placebo (Drug); Solifenacin Succinate (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Astellas Pharma Inc
Primary completion: Jul 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to End of Treatment in Overactive Bladder Questionnairre (OAB-q) Symptom Bother Score	57.9; 58.2; 37.5; 28.3; -20.4; -29.9	<0.0001 sig
SECONDARY Change From Baseline to Each Visit in Symptom Bother Utilizing the OAB-q Score	57.9; 58.2; 41.6; 35.5; -16.4; -22.6	<.0001 sig
SECONDARY Change From Baseline to Each Visit in OAB-q Health Related Quality of Life (HRQL) Total Score	57.8; 56.4; 71.4; 76.0; 13.5; 19.3	<.0001 sig
SECONDARY Number of Participants With Change From Baseline in the Global Assessment Score of the Patient Perception of Bladder Condition (PPBC)	231; 278; 131; 90	0.0006 sig
SECONDARY Patient Perception of Treatment Benefit at the End of Treatment in the Global Assessment Score of the Benefit, Satisfaction, and Willingness (BSW) Questionnaire	115; 53; 90; 80; 109; 196	—
SECONDARY Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social	53.7; 52.2; 14.9; 22.2; 18.9; 27.0	—
SECONDARY Change From Baseline in Work Productivity Assessment Index (WPAI)	1.4; 1.1; 0.8; 0.5; 0.1; -0.5	—
SECONDARY Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months	0.5; 0.5; 0.2; 0.2; -0.4; -0.3	—
SECONDARY Change From Baseline in the MCUI Behavior Therapy Stratified	14.8; 12.1; 10.3; 7.4; -4.0; -5.3	—
SECONDARY Change From Baseline in International Consultation on Incontinence Modular Questionnaire Male Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-MLUTSsex) Overall Symptom and Bother Scores.	3.6; 3.5; 3.2; 3.7; -0.1; 0.1	—
SECONDARY Change From Baseline in International Consultation on Incontinence Modular Questionnaire Female Sexual Matters Associated With Lower Urinary Tract Symptoms (ICIQ-FLUTSsex)Overall Symptom and Bother Scores.	4.9; 5.2; 3.9; 3.8; -0.9; -1.3	—
SECONDARY Change From Baseline in the Treatment Satisfaction Visual Analog Scale (TS-VAS)	32.7; 29.0; 51.2; 67.4; 18.4; 38.2	<.0001 sig
SECONDARY Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary	11.85; 11.73; 10.49; 9.50; -1.36; -2.23	—

Summary

Evaluate the effect of VESIcare® on symptom bother for subjects with OAB

Eligibility Criteria

Inclusion Criteria

Ambulatory male or female subject ≥ 18 years of age and able to use the toilet without difficulty
History of OAB symptoms for ≥ 3 months
An average of ≥ 8 micturitions per 24 hours and ≥ 1 urgency episode (with or without incontinence) per 24 hours as documented in a 3-day micturition diary
Subjects are bothered by symptoms as reflected by PPBC ≥3

Exclusion Criteria

Evidence of chronic urologic inflammation such as interstitial cystitis and bladder stones; uncontrolled narrow angle glaucoma; urinary or gastric retention
Recurrent urinary tract infection (UTI) of > 3 episodes within the last 3 months or evidence of a urinary tract infection at Baseline Visit (Visit 2)
Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator
History of renal or hepatic impairment(2 x Upper Limit of Normal(ULN) values in parameters and considered clinically significant by the investigator
History of diagnosed gastrointestinal obstruction disease
Subject has a known diagnosis or history of carcinoma (including prostate cancer) except non metastatic basal or squamous cell carcinoma of the skin that has been successfully treated or previous pelvis radiation within the past five years
Known or suspected hypersensitivity to solifenacin succinate, any components, or other anticholinergics

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00573508). 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.