Evaluation of Symptom-specific Goal Achievement

NCT ID: NCT00836823

Last Updated: 2023-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2008-08-31

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.

Conditions

Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Alpha blocker

Alfuzosin 10mg

Group Type: EXPERIMENTAL

Alfuzosin

Intervention Type: DRUG

Alfuzosin 10mg once daily for 12 months

Interventions

Alfuzosin

Alfuzosin 10mg once daily for 12 months

Intervention Type: DRUG

Other Intervention Names

XATRAL XL

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

KYU-SUNG LEE

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kyu-Sung Lee, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Asan Medical Center, Ulsan College of Medicine

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 21251673 (View on PubMed)

Other Identifiers

2005-10-044

Identifier Type: -

Identifier Source: org_study_id