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

NCT01318837 | Completed Phase 4

• 1 other identifier: OABSSVSK-002
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Over Active Bladder

Keywords

OABSS; IPSS; PPBC; Solifenacin

Outcome Measures

Primary Outcomes (2)

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

  week 0 (baseline) and week 4

• Changes from baseline to week 12 in OABSS

  week 0 (baseline) and week 12

Secondary Outcomes (6)

• 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

Study Arms (2)

sofilenacin group

EXPERIMENTAL

Drug: solifenacin

control group

NO INTERVENTION

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

Interventions

solifenacin DRUG

oral

Also known as: Vesicare

sofilenacin group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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
• Diabetic neuropathy

Sponsors & Collaborators

• Astellas Pharma Inc: lead
• Astellas Pharma Korea, Inc.: collaborator

Study Sites (2)

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Sungnam, South Korea

Location

Related Publications (1)

• Jeong SJ, Homma Y, Oh SJ. Reproducibility study of Overactive Bladder Symptom Score questionnaire and its response to treatment (RESORT) in Korean population with overactive bladder symptoms. Qual Life Res. 2014 Feb;23(1):285-92. doi: 10.1007/s11136-013-0440-7. Epub 2013 May 29.

  PMID: 23715806 BACKGROUND

MeSH Terms

Interventions

Solifenacin Succinate

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Use Central Contact

  Bundang Seoul National University Hospital, Seong Jin Jeong, MD.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2011
• First Posted: March 21, 2011
• Study Start: April 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: July 10, 2014

Record last verified: 2014-07

Locations

KR (2)