CompletedPhase 4

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

South Korea100 participantsStarted 2010-04

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Changes from baseline to week 4 in Over-Active Bladder Symptom Score (OABSS)

Timeframe: week 0 (baseline) and week 4

Changes from baseline to week 12 in OABSS

Timeframe: week 0 (baseline) and week 12

Trial details

NCT IDNCT01318837

SponsorAstellas Pharma Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-09

View on ClinicalTrials.gov More Over Active Bladder trials