Evaluation of Symptom-specific Goal Achievement

Phase 4

Completed

• Conditions: Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms
• Interventions: Drug: Alfuzosin

• Registration Number: NCT00836823
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Study First Submitted: 2009-02-02
• Study First Submitted QC: 2009-02-03
• Study First Posted: 2009-02-04
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-30
• Last Update Posted: 2023-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Alpha blocker	Alfuzosin	Alfuzosin 10mg

Primary Outcome Measures

Name	Time	Method
Patient-reported goal achievements for the most bothersome symptoms	12 months of treatment

Secondary Outcome Measures

Name	Time	Method
Patient-reported goal achievement for the most bothersome symptom using Likert scale	3, 6, and 12 months of treatment
Global impression of improvement	3, 6, and 12 months of treatment
Changes in: IPSS, ICS-male questionnaire, maximal flow rate, post-voided residual urine, voiding chart parameters	3, 6, and 12 months of treatment

Trial Locations

Locations (2)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center, Ulsan College of Medicine; 🇰🇷 Seoul, Korea, Republic of