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

Study Overview
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Brief Summary
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Evaluate the effect of VESIcare® on symptom bother for subjects with OAB

Detailed Description
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Phase 4, multi-center, randomized, double-blind, placebo-controlled, parallel group study. All subjects that meet the baseline criteria will be randomized in a 1:1 ratio into VESIcare® (solifenacin succinate) or placebo group. The study duration consists of a screening period which includes a minimum of a 14 day treatment free wash-out period. Subjects meeting the baseline criteria will have a 12 week treatment period. Maximum total study duration is 15 weeks: 2 3 week screening / washout period; 12 week double-blind treatment. Primary efficacy will be based on OAB-q symptom bother score.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 4, Multi-center Study of VESIcare® (Solifenacin Succinate) in Overactive Bladder (OAB) Subjects to Evaluate Symptom Bother and Health Related Quality of Life VIBRANT: VESIcare® Investigation of BotheR And Quality of Life iN subjecTs With OAB

Conditions
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Urinary Bladder, Overactive

Intervention / Treatment
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* Drug: Placebo
* Drug: Solifenacin Succinate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Placebo<br>Matching placebo tablet taken once daily | Drug: Placebo<br>* Oral Administration<br>|
| Experimental: Solifenacin Succinate<br>5mg or 10mg tablet taken once daily | Drug: Solifenacin Succinate<br>* Oral Administration<br>* Other names: YM905;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to End of Treatment in Overactive Bladder Questionnairre (OAB-q) Symptom Bother Score | The OAB-q is used to assess how much a patient is bothered by OAB symptoms & the impact of these symptoms on the patient's Health Related Quality of Life(HRQL). It is a patient administered tool comprised of 33 items, where the first 8 define symptom bother with raw score being converted to a scale of 0 to 100. Higher score values are indicative of greater symptom severity or bother, and a lower score in change from baseline indicates improvement. End of Treatment results include patients who had early discontinuation from the study. Change is calculated as End of Treatment - Baseline. | Baseline and 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Each Visit in Symptom Bother Utilizing the OAB-q Score | The OAB-q is used to assess how much a patient is bothered by OAB symptoms and the impact of these symptoms on the patient's HRQL. It is a validated patient administered tool comprised of 33 items, where the first 8 items define symptom bother with raw score being converted to a scale of 0 to 100. Higher score values are indicative of greater symptom severity or bother, and a lower score in change from baseline indicates improvement. Change is calculated as Actual Data for each timepoint - Baseline. | Baseline, Week 4, Week 8 and Week 12 | 
| Change From Baseline to Each Visit in OAB-q Health Related Quality of Life (HRQL) Total Score | The OAB-q is used to assess how much a patient is bothered by OAB symptoms and the impact of these symptoms on the patient's HRQL. It is a validated patient administered tool comprised of 33 items, where items 9 - 33 define HRQL with raw score being converted to a scale of 0 to 100. Higher score values are indicative of better HRQL, and a positive score in change from baseline indicates improvement. Change is calculated as Actual Data for each time point - Baseline. | Baseline, Week 4, Week 8 and Week 12 | 
| Number of Participants With Change From Baseline in the Global Assessment Score of the Patient Perception of Bladder Condition (PPBC) | The PPBC is a validated, global assessment tool using a 6-point Likert scale which requires patients to assess their bladder condition by selecting one of the following responses: 1=Does not cause me any problem at all; 2=Cause me some very minor problems; 3=Causes me some minor problems; 4=Causes me (some) moderate problems; 5=Causes me severe problems; 6=Causes me many severe problems Improvement is defined by any reduction in PPBC score. End of Treatment results include patients who had early discontinuation from the study. Change is calculated as End of Treatment (EOT) - Baseline | Baseline and 12 Weeks | 
| Patient Perception of Treatment Benefit at the End of Treatment in the Global Assessment Score of the Benefit, Satisfaction, and Willingness (BSW) Questionnaire | The BSW questionnaire is a validated instrument that can be used to assess patient satisfaction with antimuscarinic agents for OAB. It is designed to capture the patient's perception of the effect of treatment in terms of relative benefit, patient satisfaction, and patient intention or willingness to continue on therapy. | Baseline and 12 Weeks | 
| Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social | The OAB-q is used to assess how much a patient is bothered by OAB symptoms & the impact on the patient's HRQL. It is comprised of 33 items, with raw scores for each sub-domain being converted to a scale of 0 to 100. Higher score values are indicative of better HRQL, and a positive score in change from baseline indicates improvement. Change is calculated End of Treatment (EOT) for each sub-domain - Baseline. | Baseline, Week 4, Week 8 and Week 12 | 
| Change From Baseline in Work Productivity Assessment Index (WPAI) | The WPAI is a tool used to evaluate the effect of solifenacin succinate on a patient's overall satisfaction & quality of life, and included 6 questions regarding the effect that bladder condition had on ability to perform work-related functions & carry out daily activities over the past 4 weeks. The scores were converted to percentages for reporting. A negative score in Change from Baseline indicates improvement. End of Treatment results include patients who had early discontinuation from the study. Change from baseline is based on the ANCOVA model after adjusting baseline value & center. | Baseline and 12 Weeks | 
| Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months | MCUI is a Patient Reported Outcome instrument utilized to further evaluate the effect of solifenacin succinate on patient's overall satisfaction and quality of life.The tool included questions concerning the effect of the patients bladder condition on access to medical care. A negative score in Change from Baseline indicates improvement. End of Treatment results include patients who had early discontinuation from the study. Change is calculated as End of Treatment (EOT) - Baseline | Baseline and 12 Weeks | 
| Change From Baseline in the MCUI Behavior Therapy Stratified | MCUI is a Patient Reported Outcome instrument utilized to further evaluate the effect of solifenacin succinate on patient's overall satisfaction and quality of life. The tool included questions concerning the effect of the patients bladder condition on access to medical care. A negative score in Change from Baseline indicates improvement. End of Treatment results include patients who had early discontinuation from the study. Change is calculated as End of Treatment (EOT) - Baseline | Baseline and 12 Weeks | 
| 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. | ICIQ-MLUTSsex is a patient reported outcome instrument to further evaluate the effect of solifenacin succinate on patients' overall satisfaction & quality of life. The questionnaire contains 5 questions for detailed evaluation of sexual matters associated with lower urinary track symptoms & impact on sexual quality of life, with a scale of 0 to 12. Change from baseline with a negative score indicates improvement. End of Treatment results include patients who had early discontinuation. Change is calculated as End of Treatment(EOT)-Baseline. | Baseline and 12 Weeks | 
| 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. | ICIQ-FLUTSsex is a patient reported outcome instrument to further evaluate the effect of solifenacin succinate on patients' overall satisfaction & quality of life.The questionnaire contains 5 questions for detailed evaluation of sexual matters associated with lower urinary track symptoms & impact on sexual quality of life, with a scale of 0 to 14. Change from baseline with a negative score indicates improvement. End of Treatment results include patients who had early discontinuation. Change is calculated as End of Treatment(EOT)-Baseline. | Baseline and 12 Weeks | 
| Change From Baseline in the Treatment Satisfaction Visual Analog Scale (TS-VAS) | The TS-VAS is a instrument utilized to further evaluate the effect of solifenacin succinate on patients' overall satisfaction & quality of life. Each patient completed a TS-VAS to rate satisfaction with treatment. They were to answer the following question: Are you satisfied with your treatment? by placing a mark on a line that ran from 0 (no, not at all) to 100 (yes, completely). Change from baseline with a positive score indicates an improvement. The End of Treatment (EOT) results include patients who had early discontinuation from the study. Change is calculated as EOT - Baseline | Baseline and 12 Weeks | 
| Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary | The mean parameters recorded for previous 24 hours in the 3-day diary were: number of micturitions, number of incontinence episodes, number of urgency episodes, number of nocturia episodes and number of nocturnal voids. Change from baseline with a lower score indicates an improvement. End of Treatment (EOT) results include patients who had early discontinuation from the study; only patients who had the symptom at baseline and data at the EOT in the 3-day diary are included in the data table. Change is calculated as EOT - Baseline | Baseline and 12 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overactive Bladder