Evaluation of Symptom-specific Goal Achievement | NCT00836823

Studies
Evaluation of Symptom-specific Goal Achievement

NCT00836823

Sponsor

Samsung Medical Center

Status

Completed

Last Update Posted

Nov 1, 2023Actual

Enrollment

130Actual

Phase

Phase 4

Conditions

Benign Prostatic Hyperplasia
Lower Urinary Tract Symptoms

Interventions

Alfuzosin

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2005

Primary Completion Date

Aug 2008Actual

Completion Date

Aug 2008Actual

First Submitted Date

Feb 2, 2009

First Submission Date that Met QC Criteria

Feb 3, 2009

First Posted Date

Feb 4, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 30, 2023

Last Update Posted Date

Nov 1, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

130Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Alpha blocker	Experimental	Alfuzosin 10mg	Drug: Alfuzosin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Alfuzosin	Drug	Alfuzosin 10mg once daily for 12 months	Alpha blocker

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient-reported goal achievements for the most bothersome symptoms		12 months of treatment

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kyu-Sung Lee, Ph.D	Samsung Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asan Medical Center, Ulsan College of Medicine		Seoul			South Korea
Samsung Medical Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21251673	Derived	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.

ID	Term
D011469	Prostatic Diseases
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases

ID	Term
D011470	Prostatic Hyperplasia
D059411	Lower Urinary Tract Symptoms