Text Size

Evaluation of Symptom-specific Goal Achievement

This study has been completed.
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00836823
First received: February 2, 2009
Last updated: October 18, 2010
Last verified: October 2010
History of Changes
  Purpose

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 Intervention Phase
Benign Prostatic Hyperplasia
Lower Urinary Tract Symptoms
 Drug: Alfuzosin
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Patient-reported goal achievements for the most bothersome symptoms [ Time Frame: 12 months of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient-reported goal achievement for the most bothersome symptom using Likert scale [ Time Frame: 3, 6, and 12 months of treatment ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Global impression of improvement [ Time Frame: 3, 6, and 12 months of treatment ] [ Designated as safety issue: Yes ]

Enrollment: 130
Study Start Date: December 2005
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alpha blocker
Alfuzosin 10mg
 Drug: Alfuzosin
Alfuzosin 10mg once daily for 12 months
Other Name: XATRAL XL

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00836823

Locations
Korea, Republic of
Asan Medical Center, Ulsan College of Medicine
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Kyu-Sung Lee, Ph.D Samsung Medical Center
  More Information

No publications provided by Samsung Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Kyu-Sung Lee/Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00836823     History of Changes
Other Study ID Numbers: 2005-10-044
Study First Received: February 2, 2009
Last Updated: October 18, 2010
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Samsung Medical Center:
Patient-reported most bothersome symptom
Patient-reported symptom-specific goal achievement
Medical treatment

Additional relevant MeSH terms:
Prostatic Hyperplasia
Urinary Bladder Neck Obstruction
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Urethral Obstruction
Urethral Diseases
Urologic Diseases
Urinary Bladder Diseases
Pathologic Processes
Alfuzosin
 Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013