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

Primary Purpose

Overactive Bladder

Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Solifenacin
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring Solifenacin, Overactive bladder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site: 1

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Solifenacin

Arm Description

Outcomes

Primary Outcome Measures

Change in OABSS scores from prior to treatment and after treatment

Secondary Outcome Measures

Correlation of change between OABSS scores and number of micturitions per day
Correlation of change between OABSS scores and number of incontinence episodes per day
Correlation of change between OABSS scores and number of urgency episodes per day
Correlation of change between OABSS scores and number of nocturia episodes per day
Correlation of change between OABSS scores and number of total voided volume per day
Correlation of change between OABSS scores and number of pads per day
Correlation of change between OABSS scores and total International Prostate Symptom Score (IPSS) score
Correlation of change between OABSS scores and IPSS Quality of Life (QoL) score
Correlation of change between OABSS scores and Patient Perception of Bladder Condition (PPBC) total score

Full Information

First Posted
January 26, 2016
Last Updated
January 26, 2016
Sponsor
Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT02667470
Brief Title
Reproducibility Study of OABSS and Its Response to Treatment
Acronym
RESORT part 2
Official Title
Overactive Bladder Symptom Scores (OABSS) Responsiveness Before and After Anticholinergic Treatment in Women With Overactive Bladder (OAB)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
Solifenacin, Overactive bladder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Solifenacin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Solifenacin
Other Intervention Name(s)
Vesicare
Intervention Description
Oral
Primary Outcome Measure Information:
Title
Change in OABSS scores from prior to treatment and after treatment
Time Frame
Prior to treatment and after treatment (up to 12 weeks)
Secondary Outcome Measure Information:
Title
Correlation of change between OABSS scores and number of micturitions per day
Time Frame
Prior to treatment and after treatment (up to 12 weeks)
Title
Correlation of change between OABSS scores and number of incontinence episodes per day
Time Frame
Prior to treatment and after treatment (up to 12 weeks)
Title
Correlation of change between OABSS scores and number of urgency episodes per day
Time Frame
Prior to treatment and after treatment (up to 12 weeks)
Title
Correlation of change between OABSS scores and number of nocturia episodes per day
Time Frame
Prior to treatment and after treatment (up to 12 weeks)
Title
Correlation of change between OABSS scores and number of total voided volume per day
Time Frame
Prior to treatment and after treatment (up to 12 weeks)
Title
Correlation of change between OABSS scores and number of pads per day
Time Frame
Prior to treatment and after treatment (up to 12 weeks)
Title
Correlation of change between OABSS scores and total International Prostate Symptom Score (IPSS) score
Time Frame
Prior to treatment and after treatment (up to 12 weeks)
Title
Correlation of change between OABSS scores and IPSS Quality of Life (QoL) score
Time Frame
Prior to treatment and after treatment (up to 12 weeks)
Title
Correlation of change between OABSS scores and Patient Perception of Bladder Condition (PPBC) total score
Time Frame
Prior to treatment and after treatment (up to 12 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Director
Facility Information:
Facility Name
Site: 1
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Reproducibility Study of OABSS and Its Response to Treatment

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