Evaluation of Symptom-specific Goal Achievement

Samsung Medical Center

Status and phase: Completed; Phase 4

Conditions: Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia

Treatments: Drug: Alfuzosin

Study type: Interventional

Funder types: Other

Identifiers

NCT00836823

2005-10-044

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: Male

Ages: 50+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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130 participants in 1 patient group

Alpha blocker

Experimental group

Description:

Alfuzosin 10mg

Treatment:

Drug: Alfuzosin