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

Over Active Bladder Clinical Trial

— RESORT-2  

Official title:

Reproducibility Study of OABSS and Its Response to Solifenacin Treatment (RESORT) and Validity in Korean Populations; Part 2: Responsiveness and Validity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01318837
• Other study ID #: OABSSVSK-002
• Status: Completed
• Phase: Phase 4
• First received: March 17, 2011
• Last updated: July 9, 2014
• Start date: April 2010
• Est. completion date: September 2011

Study information

• Verified date: July 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Over Active Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• solifenacin
oral

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Astellas Pharma Korea, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline to week 4 in Over-Active Bladder Symptom Score (OABSS)		week 0 (baseline) and week 4	No
Primary	Changes from baseline to week 12 in OABSS		week 0 (baseline) and week 12	No
Secondary	Changes from baseline in International Prostate Symptom Score (IPSS) at week 4		week 0 (baseline) and week 4	No
Secondary	Changes from baseline in IPSS at week 12		week 0 (baseline) and week 12	No
Secondary	Changes from baseline in Quality of Life (QoL) Score at week 4		week 0 (baseline) and week 4	No
Secondary	Changes from baseline in QoL Score at week 12		week 0 (baseline) and week 12	No
Secondary	Changes from baseline in Patient Perception of Bladder Condition (PPBC) at week 4		week 0 (baseline) and week 4	No
Secondary	Changes from baseline in PPBC at week 12		week 0 (baseline) and week 12	No

External Links

•   Link to Results on JAPIC - enter 140503 in the JapicCTI-RNo. field