Evaluation of Adherence to Solifenacin Treatment in Overactive Bladder Patients

NCT00985387 | Completed

• 1 other identifier: SPK-1
• Study Type: observational
• Target: 1,215
• Locations: 1 country
• Sites: 41

Brief Summary

The purpose of the study is to assess patient's persistency in maintaining solifenacin treatment for overactive bladder.

Conditions

Urinary Bladder, Overactive; Overactive Bladder

Keywords

Solifenacin; Overactive bladder; persistency of the treatment; Vesicare

Outcome Measures

Primary Outcomes (1)

• percentage of patients who are maintaining solifenacin treatment

  Month 0, Month 1, Month 3, Month 6, Month 9 and Month 12

Secondary Outcomes (2)

• percentage of patients who discontinued solifenacin treatment

  Month 0, Month 1, Month 3, Month 6, Month 9 and Month 12

• percentage of patients who switched to other OAB medication

  Month 0, Month 1, Month 3, Month 6, Month 9 and Month 12

Study Arms (1)

Solifenacin treatment

Male and female OAB patients who were treated with solifenacin

Drug: Solifenacin

Interventions

Solifenacin DRUG

oral

Also known as: YM905, Vesicare

Solifenacin treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

OAB patients who were treated with solifenacin

You may qualify if:

• Overactive bladder symptoms lasting for more than 3 months
• The question 3 score of the overactive bladder symptom score(OABSS)≥ 2 and the sum score of OABSS ≥ 3
• Symptoms of urinary urgency defined as a level of 1 to 2 in a 3-point Urgency Perception Scale (UPS)

You may not qualify if:

• Any condition that would contraindicate their usage of anticholinergic treatment, including: urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis
• Symptomatic acute urinary tract infection (UTI)
• Diagnosed or suspected of interstitial cystitis
• Treatment with anticholinergic drugs for over 3 months within 12 months prior to the study
• Pregnant or nursing women
• Treatment within the 14 days before the study or expected to initiate treatment during the study with any anticholinergic drugs other than solifenacin or treatment for overactive bladder with other drugs

Sponsors & Collaborators

• Astellas Pharma Inc: lead
• Astellas Pharma Korea, Inc.: collaborator

Study Sites (41)

Unknown Facility

Bucheon-si, 420-717, South Korea

Location

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Bucheon-si, 420-767, South Korea

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Busan, 602-702, South Korea

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Busan, 602-715, South Korea

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Busan, 602-739, South Korea

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Busan, 614-735, South Korea

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Chuncheon, 200-704, South Korea

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Unknown Facility

Daegu, 700-712, South Korea

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Daegu, 700-721, South Korea

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Daegu, 705-717, South Korea

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Daegu, 705-718, South Korea

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Daejeon, 301-721, South Korea

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Daejeon, 302-718, South Korea

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Daejeon, 302-799, South Korea

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Gangneung, 201-711, South Korea

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Gumi, 730-728, South Korea

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Gwangju, 501-717, South Korea

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Gwangju, 501-757, South Korea

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Gwangju, 503-715, South Korea

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Gyongju, 780-350, South Korea

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Hwasun, 519-809, South Korea

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Iksan, 570-160, South Korea

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Inchon, 400-711, South Korea

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Inchon, 405-760, South Korea

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Jeonju, 361-711, South Korea

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Jeonju, 380-704, South Korea

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Jeonju, 561-712, South Korea

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Masan, 630-522, South Korea

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Seongnam, 463-707, South Korea

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Seoul, 100-380, South Korea

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Seoul, 110-744, South Korea

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Seoul, 130-702, South Korea

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Seoul, 133-792, South Korea

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Unknown Facility

Seoul, 136-705, South Korea

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Unknown Facility

Seoul, 137-701, South Korea

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Unknown Facility

Seoul, 138-736, South Korea

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Seoul, 139-711, South Korea

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Unknown Facility

Seoul, 143-729, South Korea

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Unknown Facility

Seoul, 158-710, South Korea

Location

Unknown Facility

Suwon, 443-721, South Korea

Location

Unknown Facility

Ulsan, 682-714, South Korea

Location

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

Study Officials

• Use Central Contact

  Astellas Pharma Inc

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2009
• First Posted: September 28, 2009
• Study Start: August 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: October 12, 2011

Record last verified: 2011-10

Locations

KR (41)