Evaluation of Symptom-specific Goal Achievement

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms

Intervention / Treatment
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* Drug: Alfuzosin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alpha blocker<br>Alfuzosin 10mg | Drug: Alfuzosin<br>* Alfuzosin 10mg once daily for 12 months<br>* Other names: XATRAL XL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported goal achievements for the most bothersome symptoms |  | 12 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported goal achievement for the most bothersome symptom using Likert scale |  | 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 | 
| Global impression of improvement |  | 3, 6, and 12 months of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient-reported most bothersome symptom, Patient-reported symptom-specific goal achievement, Medical treatment