A Study to Evaluate Response of Over Active Bladder Symptom Score to Solifenacin Treatment (RESORT-2)

Astellas

Status and phase: Completed; Phase 4

Conditions: Over Active Bladder

Treatments: Drug: solifenacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01318837

OABSSVSK-002

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

sofilenacin group

Experimental group

Treatment:

Drug: solifenacin

control group

No Intervention group

Description:

age and sex matched patients without OAB symptom who will answer demographic questionaire and OABSS once