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Evaluation of Symptom-specific Goal Achievement

Sponsor
Samsung Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00836823
Collaborator
(none)
130
Enrollment
2
Locations
1
Arm
32
Duration (Months)
65
Patients Per Site
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) consists of a constellation of symptoms (including voiding, storage, and post-micturition). The impact of the LUTS on patients' health-related quality of life is substantial and multifaceted. Thus, the therapies aimed at treating BPH are concerned primarily with improving patients' symptoms, thereby improving quality of life. When multiple symptoms are present, the level of bother associated with individual symptoms varies and patients prioritize their treatment goals for symptom relief. A measure that addresses patients' most bothersome symptoms (MBS) and evaluation of symptom-specific goal achievements may lead to improved outcomes and patient satisfaction to the treatment. The objectives of this study were (1) to assess patient-reported MBS and symptom-specific goal achievements (PGA) with medical treatment in BPH patients, and (2) to identify factors that influence or have relation to the PGA.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
130 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Long Term Effects of Alfuzosin (Xatral XL) in LUTS/BPH Patients: Evaluation of Symptom-specific Goal Achievement According to Symptom Improvement, Bladder Outlet Obstruction Grade and Bladder Contractility
Study Start Date :
Dec 1, 2005
Actual Primary Completion Date :
Aug 1, 2008
Actual Study Completion Date :
Aug 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: Alpha blocker

Alfuzosin 10mg

Drug: Alfuzosin
Alfuzosin 10mg once daily for 12 months
Other Names:
  • XATRAL XL

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Patient-reported goal achievements for the most bothersome symptoms [12 months of treatment]

    Secondary Outcome Measures

    1. Patient-reported goal achievement for the most bothersome symptom using Likert scale [3, 6, and 12 months of treatment]

    2. Changes in: IPSS, ICS-male questionnaire, maximal flow rate, post-voided residual urine, voiding chart parameters [3, 6, and 12 months of treatment]

    3. Global impression of improvement [3, 6, and 12 months of treatment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • males ≥50 years with LUTS secondary to BPH

    • Moderate to severe LUTS : IPSS ≥ 8

    • An enlarged prostate : TRUS ≥25 mL

    • Decreased peak flow rate : Qmax ≤15mL/s (volume voided ≥ 120 mL)

    • Having signed the informed consent to participate in the study.

    Exclusion Criteria:

    • Post voided residual urine ≥ 200mL

    • Patients performing catheterization

    • Urinary tract infection patients

    • Patients taking 5 alpha reductase inhibitor

    • Known hypersensitivity to alfuzosin

    • History of postural hypotension or syncope

    • Hypertension patients treated with other alpha1-blockers

    • Patients newly taking anticholinergic medication within 1 month

    • Hepatic insufficiency (AST/ALT ≥ 2 times of normal range)

    • Renal insufficiency (s-Cr ≥ 2mg/dL)

    • Unstable angina pectoris

    • Uninvestigated hematuria

    • Serum PSA ≥ 4 ng/mL (biopsy proven no cancer patients can be included)

    • Interstitial cystitis patients

    • Severe concomitant condition threatening life.

    • Patient who is unable to make voiding diary

    • Bladder or prostate cancer patients

    • Patients receiving prostate or bladder surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Asan Medical Center, Ulsan College of Medicine Seoul Korea, Republic of
    2 Samsung Medical Center Seoul Korea, Republic of

    Sponsors and Collaborators

    • Samsung Medical Center

    Investigators

    • Principal Investigator: Kyu-Sung Lee, Ph.D, Samsung Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00836823
    Other Study ID Numbers:
    • 2005-10-044
    First Posted:
    Feb 4, 2009
    Last Update Posted:
    Oct 20, 2010
    Last Verified:
    Oct 1, 2010
    Keywords provided by , ,
    Patient-reported most bothersome symptom
    Patient-reported symptom-specific goal achievement
    Medical treatment
    Additional relevant MeSH terms:
    Prostatic Hyperplasia
    Hyperplasia
    Lower Urinary Tract Symptoms
    Alfuzosin

    Study Results

    No Results Posted as of Oct 20, 2010