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Evaluation of Symptom-specific Goal Achievement

Primary Purpose

Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Alfuzosin
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring Patient-reported most bothersome symptom, Patient-reported symptom-specific goal achievement, Medical treatment

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Asan Medical Center, Ulsan College of Medicine
  • Samsung Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Alpha blocker

Arm Description

Alfuzosin 10mg

Outcomes

Primary Outcome Measures

Patient-reported goal achievements for the most bothersome symptoms

Secondary Outcome Measures

Patient-reported goal achievement for the most bothersome symptom using Likert scale
Changes in: IPSS, ICS-male questionnaire, maximal flow rate, post-voided residual urine, voiding chart parameters
Global impression of improvement

Full Information

First Posted
February 2, 2009
Last Updated
October 18, 2010
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00836823
Brief Title
Evaluation of Symptom-specific Goal Achievement
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 Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
Keywords
Patient-reported most bothersome symptom, Patient-reported symptom-specific goal achievement, Medical treatment

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Alpha blocker
Arm Type
Experimental
Arm Description
Alfuzosin 10mg
Intervention Type
Drug
Intervention Name(s)
Alfuzosin
Other Intervention Name(s)
XATRAL XL
Intervention Description
Alfuzosin 10mg once daily for 12 months
Primary Outcome Measure Information:
Title
Patient-reported goal achievements for the most bothersome symptoms
Time Frame
12 months of treatment
Secondary Outcome Measure Information:
Title
Patient-reported goal achievement for the most bothersome symptom using Likert scale
Time Frame
3, 6, and 12 months of treatment
Title
Changes in: IPSS, ICS-male questionnaire, maximal flow rate, post-voided residual urine, voiding chart parameters
Time Frame
3, 6, and 12 months of treatment
Title
Global impression of improvement
Time Frame
3, 6, and 12 months of treatment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyu-Sung Lee, Ph.D
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center, Ulsan College of Medicine
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
21251673
Citation
Lee YS, Lee HN, Han JY, Choo MS, Lee KS. Most bothersome symptom and symptom specific goal achievement in patients with benign prostatic obstruction: a prospective open label study. J Urol. 2011 Mar;185(3):1003-9. doi: 10.1016/j.juro.2010.10.085. Epub 2011 Jan 19.
Results Reference
derived

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Evaluation of Symptom-specific Goal Achievement

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