Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
Conditions
Keywords
Patient-reported most bothersome symptom, Patient-reported symptom-specific goal achievement, Medical treatment
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.
Interventions
DRUGAlfuzosin
Alfuzosin 10mg once daily for 12 months
Sponsors
Samsung Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient-reported goal achievements for the most bothersome symptoms | 12 months of treatment |
Secondary
| Measure | 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 |
Countries
South Korea
Outcome results
None listed