NCT00836823

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2005

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 4, 2009

Completed
Last Updated

November 1, 2023

Status Verified

October 1, 2023

Enrollment Period

2.7 years

First QC Date

February 2, 2009

Last Update Submit

October 30, 2023

Conditions

Benign Prostatic HyperplasiaLower Urinary Tract Symptoms

Keywords

Patient-reported most bothersome symptomPatient-reported symptom-specific goal achievementMedical treatment

Outcome Measures

Primary Outcomes (1)

  • Patient-reported goal achievements for the most bothersome symptoms

    12 months of treatment

Secondary Outcomes (3)

  • 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

Study Arms (1)

Alpha blocker

EXPERIMENTAL

Alfuzosin 10mg

Drug: Alfuzosin

Interventions

AlfuzosinDRUG

Alfuzosin 10mg once daily for 12 months

Also known as: XATRAL XL
Alpha blocker

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Asan Medical Center, Ulsan College of Medicine

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 21251673DERIVED

MeSH Terms

Conditions

Prostatic HyperplasiaLower Urinary Tract Symptoms

Interventions

alfuzosin

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kyu-Sung Lee, Ph.D

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

February 2, 2009

First Posted

February 4, 2009

Study Start

December 1, 2005

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

November 1, 2023

Record last verified: 2023-10

Locations

KR(2)