Reproducibility Study of OABSS and Its Response to Treatment

Overactive Bladder Clinical Trial

— RESORT part 2  

Official title:

Overactive Bladder Symptom Scores (OABSS) Responsiveness Before and After Anticholinergic Treatment in Women With Overactive Bladder (OAB)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02667470
• Other study ID #: ATH-002
• Status: Completed
• Phase: Phase 4
• First received: January 26, 2016
• Last updated: January 26, 2016
• Start date: September 2009
• Est. completion date: May 2013

Study information

• Verified date: January 2016
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate change of Overactive Bladder (OAB) Symptom Score (OABSS) scores between before and after Solifenacin treatment to OAB patients and to evaluate correlation between change of OABSS scores and other measures for OAB symptoms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At screening visit (Week -2):

• Symptoms of OAB = 3 months

• Number of urgency episodes in last 3 days = 3

• Based on the 3-day micturition diary prior to Visit 1 (Week 0):

• Number of micturition per day = 8

• Number of urgency episodes in 3 days = 3

Exclusion Criteria:

• At screening visit (Week -2):

• Stress is the predominant factor as determined by the investigator

• Indwelling catheters or practicing intermittent self-catheterization

• Symptomatic urinary tract infection, chronic inflammation

• Treatment for OAB was started, quitted or changed in 4 weeks

• Diabetic neuropathy

• At Visit 1 (Week 0):

• Patient who did not complete the 3-day micturition diary according to the instruction

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• Solifenacin
Oral

Locations

Country	Name	City	State
Thailand	Site: 1	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in OABSS scores from prior to treatment and after treatment		Prior to treatment and after treatment (up to 12 weeks)	No
Secondary	Correlation of change between OABSS scores and number of micturitions per day		Prior to treatment and after treatment (up to 12 weeks)	No
Secondary	Correlation of change between OABSS scores and number of incontinence episodes per day		Prior to treatment and after treatment (up to 12 weeks)	No
Secondary	Correlation of change between OABSS scores and number of urgency episodes per day		Prior to treatment and after treatment (up to 12 weeks)	No
Secondary	Correlation of change between OABSS scores and number of nocturia episodes per day		Prior to treatment and after treatment (up to 12 weeks)	No
Secondary	Correlation of change between OABSS scores and number of total voided volume per day		Prior to treatment and after treatment (up to 12 weeks)	No
Secondary	Correlation of change between OABSS scores and number of pads per day		Prior to treatment and after treatment (up to 12 weeks)	No
Secondary	Correlation of change between OABSS scores and total International Prostate Symptom Score (IPSS) score		Prior to treatment and after treatment (up to 12 weeks)	No
Secondary	Correlation of change between OABSS scores and IPSS Quality of Life (QoL) score		Prior to treatment and after treatment (up to 12 weeks)	No
Secondary	Correlation of change between OABSS scores and Patient Perception of Bladder Condition (PPBC) total score		Prior to treatment and after treatment (up to 12 weeks)	No