Clinical trial NCT00836823: Evaluation of Symptom-specific Goal Achievement
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Benign Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Keywords: Patient-reported most bothersome symptom
Patient-reported symptom-specific goal achievement
Medical treatment
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2009-02-04
Enrollment: 130
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Patient-reported goal achievements for the most bothersome symptoms
timeFrame: 12 months of treatment
Secondary outcomes:
measure: Patient-reported goal achievement for the most bothersome symptom using Likert scale
timeFrame: 3, 6, and 12 months of treatment
measure: Changes in: IPSS, ICS-male questionnaire, maximal flow rate, post-voided residual urine, voiding chart parameters
timeFrame: 3, 6, and 12 months of treatment
measure: Global impression of improvement
timeFrame: 3, 6, and 12 months of treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center, Ulsan College of Medicine
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Kyu-Sung Lee, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee YS, Lee HN, Han JY, Choo MS, Lee KS. Most bothersome symptom and symptom specific goal achievement in patients with benign prostatic obstruction: a prospective open label study. J Urol. 2011 Mar;185(3):1003-9. doi: 10.1016/j.juro.2010.10.085. Epub 2011 Jan 19.