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NCT01122563 Clinical Trial

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

Overactive Bladder Clinical Trial

— RESORT-2  

Official title:
Reproducibility Study of OABSS and Its Response to Treatment in Indonesia - Part 2: Responsiveness

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01122563
Other study ID # EQL-CRU.005-2009
Secondary ID
Status Completed
Phase N/A
First received May 11, 2010
Last updated January 11, 2011
Start date September 2009
Est. completion date January 2011

Study information
Verified date January 2011
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority Indonesia: National Agency of Drug and Food Control
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 55
Est. completion date January 2011
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Solifenacin
oral

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Astellas Pharma Inc Astellas Pharma Indonesia Inc.

Country where clinical trial is conducted

Indonesia, 

Outcome
Type Measure Description Time frame Safety issue
Primary OABSS Weeks 0, 4 and 12 No
Secondary International Prostate Symptom Score (IPSS) Weeks 0, 4 and 12 No
Secondary Quality of Life (QOL) Score Weeks 0, 4 and 12 No
Secondary Patient Perception of Bladder Condition (PPBC) Weeks 0, 4 and 12 No
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