A Study to Evaluate Response of Overactive Bladder Symptom Score (OABSS) to Treatment (RESORT-2)

Astellas

Status: Completed

Conditions: Overactive Bladder

Treatments: Drug: Solifenacin

Study type: Observational

Funder types: Industry

Identifiers

NCT01122563

EQL-CRU.005-2009

Details and patient eligibility

About

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

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

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