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

Sponsor
Astellas Pharma Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT02667470
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
44
Duration (Months)
1.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Overactive Bladder Symptom Scores (OABSS) Responsiveness Before and After Anticholinergic Treatment in Women With Overactive Bladder (OAB)
Study Start Date :
Sep 1, 2009
Actual Primary Completion Date :
May 1, 2013
Actual Study Completion Date :
May 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Solifenacin

Drug: Solifenacin
Oral
Other Names:
  • Vesicare

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in OABSS scores from prior to treatment and after treatment [Prior to treatment and after treatment (up to 12 weeks)]

    Secondary Outcome Measures

    1. Correlation of change between OABSS scores and number of micturitions per day [Prior to treatment and after treatment (up to 12 weeks)]

    2. Correlation of change between OABSS scores and number of incontinence episodes per day [Prior to treatment and after treatment (up to 12 weeks)]

    3. Correlation of change between OABSS scores and number of urgency episodes per day [Prior to treatment and after treatment (up to 12 weeks)]

    4. Correlation of change between OABSS scores and number of nocturia episodes per day [Prior to treatment and after treatment (up to 12 weeks)]

    5. Correlation of change between OABSS scores and number of total voided volume per day [Prior to treatment and after treatment (up to 12 weeks)]

    6. Correlation of change between OABSS scores and number of pads per day [Prior to treatment and after treatment (up to 12 weeks)]

    7. Correlation of change between OABSS scores and total International Prostate Symptom Score (IPSS) score [Prior to treatment and after treatment (up to 12 weeks)]

    8. Correlation of change between OABSS scores and IPSS Quality of Life (QoL) score [Prior to treatment and after treatment (up to 12 weeks)]

    9. 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)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Site: 1 Bangkok Thailand 10330

    Sponsors and Collaborators

    • Astellas Pharma Inc

    Investigators

    • Study Director: Medical Director, Astellas Pharma Inc

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Astellas Pharma Inc
    ClinicalTrials.gov Identifier:
    NCT02667470
    Other Study ID Numbers:
    • ATH-002
    First Posted:
    Jan 29, 2016
    Last Update Posted:
    Jan 29, 2016
    Last Verified:
    Jan 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Astellas Pharma Inc
    Solifenacin
    Overactive bladder
    Additional relevant MeSH terms:
    Urinary Bladder, Overactive
    Solifenacin Succinate

    Study Results

    No Results Posted as of Jan 29, 2016