A Study to Evaluate Response of Over Active Bladder Symptom Score to Solifenacin Treatment

Phase 4

Completed

• Conditions: Over Active Bladder
• Interventions: Drug: solifenacin

• Registration Number: NCT01318837
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2011-03-17
• Study First Submitted QC: 2011-03-17
• Study First Posted: 2011-03-21
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-09
• Last Update Posted: 2014-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Symptoms of OAB for 3 months or longer

• At least 1 urgency episode in last 3 days

• Symptoms of OAB as verified by the screening 3-day bladder diary, defined by:

  • a. Number of micturition ≥8 times/day
  • b. Number of urgency episodes in 3 days ≥3

Exclusion Criteria

• 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
• Diabetic neuropathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sofilenacin group	solifenacin	-

Primary Outcome Measures

Name	Time	Method
Changes from baseline to week 12 in OABSS	week 0 (baseline) and week 12
Changes from baseline to week 4 in Over-Active Bladder Symptom Score (OABSS)	week 0 (baseline) and week 4

Secondary Outcome Measures

Name	Time	Method
Changes from baseline in International Prostate Symptom Score (IPSS) at week 4	week 0 (baseline) and week 4
Changes from baseline in IPSS at week 12	week 0 (baseline) and week 12
Changes from baseline in Quality of Life (QoL) Score at week 4	week 0 (baseline) and week 4
Changes from baseline in QoL Score at week 12	week 0 (baseline) and week 12
Changes from baseline in Patient Perception of Bladder Condition (PPBC) at week 4	week 0 (baseline) and week 4
Changes from baseline in PPBC at week 12	week 0 (baseline) and week 12