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

NCT00573508 | Completed Phase 4 Results

• 1 other identifier: 905-UC-010
• Study Type: interventional
• Target: 768
• Locations: 1 country
• Sites: 59

Brief Summary

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

Conditions

Urinary Bladder, Overactive

Keywords

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Change From Baseline to Each Visit in Symptom Bother Utilizing the OAB-q Score

  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

  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)

  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

  Baseline and 12 Weeks

• Change From Baseline to Each Visit in the OAB-q HRQL Sub-domain Scores of Coping, Concern, Sleep and Social

  Baseline, Week 4, Week 8 and Week 12

Study Arms (2)

Placebo

ACTIVE COMPARATOR

Matching placebo tablet taken once daily

Drug: Placebo

Solifenacin Succinate

EXPERIMENTAL

5mg or 10mg tablet taken once daily

Drug: Solifenacin Succinate

Interventions

Placebo DRUG

Oral Administration

Placebo

Solifenacin Succinate DRUG

Oral Administration

Also known as: VESIcare®, YM905

Solifenacin Succinate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (59)

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Montgomery, Alabama, 36067, United States

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Phoenix, Arizona, 85051, United States

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Tucson, Arizona, 85741, United States

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Buena Park, California, 90620, United States

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Carmichael, California, 95608, United States

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Fresno, California, 93720, United States

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Sacramento, California, 95825, United States

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San Bernardino, California, 92404, United States

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San Diego, California, 92108, United States

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Aurora, Colorado, 80012, United States

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Denver, Colorado, 80211, United States

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Denver, Colorado, 80220, United States

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Englewood, Colorado, 32308, United States

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Waterbury, Connecticut, 67080, United States

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Clearwater, Florida, 33761, United States

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Plantation, Florida, 33324, United States

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Tallahassee, Florida, 32308, United States

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Tampa, Florida, 33607, United States

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Tampa, Florida, 33613, United States

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Wellington, Florida, 33414, United States

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Roswell, Georgia, 30076, United States

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Idaho Falls, Idaho, 83404, United States

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Melrose Park, Illinois, 60160, United States

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Jeffersonville, Indiana, 47130, United States

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Shreveport, Louisiana, 71106, United States

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Watertown, Massachusetts, 02472, United States

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Billings, Montana, 59102, United States

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Omaha, Nebraska, 68114, United States

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Englewood, New Jersey, 07631, United States

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Lawrenceville, New Jersey, 08648, United States

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Endwell, New York, 13760, United States

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Garden City, New York, 11530, United States

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Kingston, New York, 12401, United States

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New York, New York, 10016, United States

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New York, New York, 10029, United States

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Orchard Park, New York, 14127, United States

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Poughkeepsie, New York, 12601, United States

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Concord, North Carolina, 28025, United States

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Raleigh, North Carolina, 27612, United States

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Winston-Salem, North Carolina, 27103, United States

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Fargo, North Dakota, 58104, United States

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Cincinnati, Ohio, 45212, United States

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Lyndhurst, Ohio, 44124, United States

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Edmond, Oklahoma, 73034, United States

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Central Point, Oregon, 97502, United States

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Philadelphia, Pennsylvania, 19114, United States

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Uniontown, Pennsylvania, 15401, United States

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West Reading, Pennsylvania, 19611, United States

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Greer, South Carolina, 29650, United States

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Simpsonville, South Carolina, 29681, United States

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Arlington, Texas, 76017, United States

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Austin, Texas, 78759, United States

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Bedford, Texas, 76021, United States

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Corpus Christi, Texas, 78414, United States

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Houston, Texas, 77024, United States

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Mount Lake, Washington, 98043, United States

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Spokane, Washington, 99202, United States

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Tacoma, Washington, 98405, United States

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Madison, Wisconsin, 53703, United States

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Related Publications (3)

• 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.

  PMID: 19930331 RESULT

• Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.

  PMID: 37160401 DERIVED

• 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.

  PMID: 21235700 DERIVED

Related Links

• Link to Prescribing Information

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Solifenacin Succinate

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.

Results Point of Contact

• Title: Astellas Medical Monitor
• Organization: Astellas Pharma Global Development

clinicaltrials@us.astellas.com

Study Officials

• Central Contact

  Astellas Pharma US, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 12, 2007
• First Posted: December 14, 2007
• Study Start: August 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: October 5, 2010
• Results First Posted: October 5, 2010

Record last verified: 2010-09

Locations

US (59)