Evaluation of Symptom-specific Goal Achievement

Samsung Medical Center130 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

130

Conditions

Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms

Eligibility

Sex: MALEMin age: 50 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Patient-reported goal achievements for the most bothersome symptoms

Time frame: 12 months of treatment

Secondary Outcomes

Patient-reported goal achievement for the most bothersome symptom using Likert scale

Time frame: 3, 6, and 12 months of treatment

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

Global impression of improvement

Time frame: 3, 6, and 12 months of treatment

Evaluation of Symptom-specific Goal Achievement

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes