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

Primary Purpose

Urinary Bladder, Overactive

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Placebo
Solifenacin Succinate
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Bladder, Overactive focused on measuring Overactive Bladder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Placebo

Solifenacin Succinate

Arm Description

Matching placebo tablet taken once daily

5mg or 10mg tablet taken once daily

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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
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.
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.
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.
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
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
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.
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.
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
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

Full Information

First Posted
December 12, 2007
Last Updated
September 7, 2010
Sponsor
Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00573508
Brief Title
Study of VESIcare® In Overactive Bladder (OAB) Subjects to Evaluate Symptom Bother and Health Related Quality of Life
Acronym
VIBRANT
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Astellas Pharma Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Evaluate the effect of VESIcare® on symptom bother for subjects with OAB
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder, Overactive
Keywords
Overactive Bladder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
768 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Active Comparator
Arm Description
Matching placebo tablet taken once daily
Arm Title
Solifenacin Succinate
Arm Type
Experimental
Arm Description
5mg or 10mg tablet taken once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral Administration
Intervention Type
Drug
Intervention Name(s)
Solifenacin Succinate
Other Intervention Name(s)
VESIcare®, YM905
Intervention Description
Oral Administration
Primary Outcome Measure Information:
Title
Change From Baseline to End of Treatment in Overactive Bladder Questionnairre (OAB-q) Symptom Bother Score
Description
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.
Time Frame
Baseline and 12 Weeks
Secondary Outcome Measure Information:
Title
Change From Baseline to Each Visit in Symptom Bother Utilizing the OAB-q Score
Description
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.
Time Frame
Baseline, Week 4, Week 8 and Week 12
Title
Change From Baseline to Each Visit in OAB-q Health Related Quality of Life (HRQL) Total Score
Description
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.
Time Frame
Baseline, Week 4, Week 8 and Week 12
Title
Number of Participants With Change From Baseline in the Global Assessment Score of the Patient Perception of Bladder Condition (PPBC)
Description
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
Time Frame
Baseline and 12 Weeks
Title
Patient Perception of Treatment Benefit at the End of Treatment in the Global Assessment Score of the Benefit, Satisfaction, and Willingness (BSW) Questionnaire
Description
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.
Time Frame
Baseline and 12 Weeks
Title
Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social
Description
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.
Time Frame
Baseline, Week 4, Week 8 and Week 12
Title
Change From Baseline in Work Productivity Assessment Index (WPAI)
Description
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.
Time Frame
Baseline and 12 Weeks
Title
Change From Baseline in the Medical Care Use Index (MCUI) Medical Resource Utilization in the Past 3 Months
Description
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
Time Frame
Baseline and 12 Weeks
Title
Change From Baseline in the MCUI Behavior Therapy Stratified
Description
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
Time Frame
Baseline and 12 Weeks
Title
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.
Description
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.
Time Frame
Baseline and 12 Weeks
Title
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.
Description
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.
Time Frame
Baseline and 12 Weeks
Title
Change From Baseline in the Treatment Satisfaction Visual Analog Scale (TS-VAS)
Description
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
Time Frame
Baseline and 12 Weeks
Title
Change From Baseline to End of Treatment in Mean Parameters Per 24 Hours Recorded in 3-day Diary
Description
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
Time Frame
Baseline and 12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Central Contact
Organizational Affiliation
Astellas Pharma US, Inc.
Official's Role
Study Director
Facility Information:
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36067
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85051
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
City
Buena Park
State/Province
California
ZIP/Postal Code
90620
Country
United States
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
City
San Bernardino
State/Province
California
ZIP/Postal Code
92404
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80211
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
City
Englewood
State/Province
Colorado
ZIP/Postal Code
32308
Country
United States
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
67080
Country
United States
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
City
Melrose Park
State/Province
Illinois
ZIP/Postal Code
60160
Country
United States
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
City
Kingston
State/Province
New York
ZIP/Postal Code
12401
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
City
Orchard Park
State/Province
New York
ZIP/Postal Code
14127
Country
United States
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
City
Lyndhurst
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73034
Country
United States
City
Central Point
State/Province
Oregon
ZIP/Postal Code
97502
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
City
Simpsonville
State/Province
South Carolina
ZIP/Postal Code
29681
Country
United States
City
Arlington
State/Province
Texas
ZIP/Postal Code
76017
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
City
Bedford
State/Province
Texas
ZIP/Postal Code
76021
Country
United States
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78414
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
City
Mount Lake
State/Province
Washington
ZIP/Postal Code
98043
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53703
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19930331
Citation
Vardy MD, Mitcheson HD, Samuels TA, Wegenke JD, Forero-Schwanhaeuser S, Marshall TS, He W. Effects of solifenacin on overactive bladder symptoms, symptom bother and other patient-reported outcomes: results from VIBRANT - a double-blind, placebo-controlled trial. Int J Clin Pract. 2009 Dec;63(12):1702-14. doi: 10.1111/j.1742-1241.2009.02209.x.
Results Reference
result
PubMed Identifier
21235700
Citation
Crosby RD, Mathias SD, Marshall TS. Relationships between symptoms, symptom bother, and health-related quality of life in patients with overactive bladder taking solifenacin or placebo in the VIBRANT study. Int J Clin Pract. 2011 Feb;65(2):211-8. doi: 10.1111/j.1742-1241.2010.02532.x.
Results Reference
derived
Links:
URL
http://www.astellas.us/docs/vesicare.pdf
Description
Link to Prescribing Information

Learn more about this trial

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

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