NCT01122563

Brief Summary

This study is to evaluate change of overactive bladder symptom scores (OABSS) between, before and after solifenacin treatment to OAB subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

3 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

September 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 13, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

January 13, 2011

Status Verified

January 1, 2011

Enrollment Period

1.3 years

First QC Date

May 11, 2010

Last Update Submit

January 11, 2011

Conditions

Overactive Bladder

Keywords

OABSSIPSSPPBC3-day micturition diarySolifenacin

Outcome Measures

Primary Outcomes (1)

  • OABSS

    Weeks 0, 4 and 12

Secondary Outcomes (3)

  • International Prostate Symptom Score (IPSS)

    Weeks 0, 4 and 12

  • Quality of Life (QOL) Score

    Weeks 0, 4 and 12

  • Patient Perception of Bladder Condition (PPBC)

    Weeks 0, 4 and 12

Interventions

SolifenacinDRUG

oral

Also known as: Vesicare

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Symptomatic OAB patients having urgency episodes

You may qualify if:

  • Symptoms OAB for 3 months or longer
  • At least 3 urgency episode in last 3 days
  • Symptoms of OAB as verified by the screening 3-day bladder diary, defined by:
  • Number of micturition ≥8 times/day
  • Number of urgency episodes in 3 days ≥3

You may not qualify if:

  • Significant stress incontinence or mixed stress/urge incontinence
  • Subject with indwelling catheters or practicing intermittent self-catheterization
  • Symptomatic urinary tract infection, chronic inflammation
  • Diabetic neuropathy
  • Subjects who are prohibited from taking solifenacin as contraindications
  • Drug or non-drug treatment for OAB was started, quitted or changed in 4 weeks
  • Participation in any clinical trial in 30 days except for Part-1 of RESORT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Bandung, Indonesia

Location

Unknown Facility

Jakarta, Indonesia

Location

Unknown Facility

Surabaya, Indonesia

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 Indonesia

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 11, 2010

First Posted

May 13, 2010

Study Start

September 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

January 13, 2011

Record last verified: 2011-01

Locations

ID(3)