NCT01489709

Brief Summary

This study is to evaluate the effect of Vesicare on quality of life (QOL) in female patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,160

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2010

Shorter than P25 for all trials

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 12, 2011

Completed
Last Updated

September 5, 2014

Status Verified

September 1, 2014

Enrollment Period

10 months

First QC Date

December 8, 2011

Last Update Submit

September 4, 2014

Conditions

Overactive Bladder

Keywords

overactive bladdersolifenacinOveractive bladder questionnaireOveractive Bladder Symptom Scoresatisfaction score

Outcome Measures

Primary Outcomes (1)

  • Changes in OAB-q (overactive bladder questionnaire)

    Baseline and at 12 weeks (or last observation period)

Secondary Outcomes (2)

  • Changes in OABSS (overactive bladder symptom score)

    Baseline and at 12 weeks (or last observation period)

  • Changes in satisfaction score for urination

    Baseline and at 12 weeks (or last observation period)

Study Arms (1)

Vesicare group

Who receive vesicare

Drug: Vesicare

Interventions

VesicareDRUG

oral

Also known as: solifenacin
Vesicare group

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who meet the diagnostic criteria for OAB provided in the clinical guidelines for overactive bladder (patients who have urinary urgency at least once weekly as an essential symptom and at least one of the other OAB symptoms including daytime frequency, nighttime frequency, and urgency incontinence)

You may qualify if:

  • Previously untreated OAB patients
  • Patients who meet the diagnostic criteria for OAB provided in the clinical guidelines for overactive bladder (patients who have urinary urgency at least once weekly as an essential symptom and at least one of the other OAB symptoms including daytime frequency, nighttime frequency, and urgency incontinence)
  • Patients who can understand and answer OAB-q (Japanese version)
  • Patients from whom data on all items concerning OABSS, OAB-q, and satisfaction score for urination can be obtained at baseline
  • Patients who are expected to be treated for at least 12 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Chugoku, Japan

Location

Unknown Facility

Chūbu, Japan

Location

Unknown Facility

Hokkaido, Japan

Location

Unknown Facility

Kansai, Japan

Location

Unknown Facility

Kantou, Japan

Location

Unknown Facility

Kyushu, Japan

Location

Unknown Facility

Shikoku, Japan

Location

Unknown Facility

Tōhoku, Japan

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Solifenacin Succinate

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

QuinuclidinesHeterocyclic Compounds, Bridged-RingHeterocyclic CompoundsTetrahydroisoquinolinesIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic 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

December 8, 2011

First Posted

December 12, 2011

Study Start

June 1, 2010

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

September 5, 2014

Record last verified: 2014-09

Locations

JP(8)