Reproducibility Study of OABSS and Its Response to Treatment

Phase 4

Completed

• Conditions: Overactive Bladder
• Interventions: Drug: Solifenacin

• Registration Number: NCT02667470
• Lead Sponsor: Astellas Pharma Inc

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2016-01
• Study First Submitted: 2016-01-26
• Study First Submitted QC: 2016-01-26
• Last Update Submitted: 2016-01-26
• Study First Posted: 2016-01-29
• Last Update Posted: 2016-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Solifenacin	Solifenacin	-

Primary Outcome Measures

Name	Time	Method
Change in OABSS scores from prior to treatment and after treatment	Prior to treatment and after treatment (up to 12 weeks)

Secondary Outcome Measures

Name	Time	Method
Correlation of change between OABSS scores and total International Prostate Symptom Score (IPSS) score	Prior to treatment and after treatment (up to 12 weeks)
Correlation of change between OABSS scores and IPSS Quality of Life (QoL) score	Prior to treatment and after treatment (up to 12 weeks)
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)
Correlation of change between OABSS scores and number of micturitions per day	Prior to treatment and after treatment (up to 12 weeks)
Correlation of change between OABSS scores and number of nocturia episodes per day	Prior to treatment and after treatment (up to 12 weeks)
Correlation of change between OABSS scores and number of total voided volume per day	Prior to treatment and after treatment (up to 12 weeks)
Correlation of change between OABSS scores and number of incontinence episodes per day	Prior to treatment and after treatment (up to 12 weeks)
Correlation of change between OABSS scores and number of urgency episodes per day	Prior to treatment and after treatment (up to 12 weeks)
Correlation of change between OABSS scores and number of pads per day	Prior to treatment and after treatment (up to 12 weeks)

Trial Locations

Locations (1)

Site: 1; 🇹🇭 Bangkok, Thailand