Evaluation of Symptom-specific Goal Achievement

Benign Prostatic Hyperplasia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00836823
• Other study ID #: 2005-10-044
• Status: Completed
• Phase: Phase 4
• Start date: December 2005
• Est. completion date: August 2008

Study information

• Verified date: October 2023
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia

Intervention

Drug:
• Alfuzosin
Alfuzosin 10mg once daily for 12 months

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center, Ulsan College of Medicine	Seoul
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-reported goal achievements for the most bothersome symptoms		12 months of treatment
Secondary	Patient-reported goal achievement for the most bothersome symptom using Likert scale		3, 6, and 12 months of treatment
Secondary	Changes in: IPSS, ICS-male questionnaire, maximal flow rate, post-voided residual urine, voiding chart parameters		3, 6, and 12 months of treatment
Secondary	Global impression of improvement		3, 6, and 12 months of treatment