Reproducibility Study of OABSS and Its Response to Treatment (RESORT part 2)

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

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.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Drug: Solifenacin

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10330
    • Site: 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Solifenacin	Drug: Solifenacin; Oral; Other Names: Vesicare

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in OABSS scores from prior to treatment and after treatment	Prior to treatment and after treatment (up to 12 weeks)

Secondary Outcome Measures

Outcome Measure	Time Frame
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 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 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 pads per day	Prior to treatment and after treatment (up to 12 weeks)
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)

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: January 26, 2016
• First Submitted That Met QC Criteria: January 26, 2016
• First Posted (Estimate): January 29, 2016

Study Record Updates

• Last Update Posted (Estimate): January 29, 2016
• Last Update Submitted That Met QC Criteria: January 26, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Overactive bladder; Solifenacin
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Solifenacin Succinate
• Other Study ID Numbers: ATH-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided