Benign Prostatic HyperplasiaPhase 4NCT00836823
Evaluation of Symptom-specific Goal Achievement
A Phase 4 study testing Alfuzosin in people with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by Samsung Medical Center at 2 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
- What is being tested?
- Alfuzosin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Dec 2005to Aug 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Asan Medical Center, Ulsan College of Medicine
Seoul
Samsung Medical Center
Seoul
About this study
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
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.
- Being tested
- Alfuzosin
- Keywords
- Patient-reported most bothersome symptom, Patient-reported symptom-specific goal achievement, Medical treatment
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlfuzosinDrug
Also called XATRAL XL
Alfuzosin 10mg once daily for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Alpha blocker | Experimental | Alfuzosin 10mg Receives: Drug: Alfuzosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported goal achievements for the most bothersome symptoms
Measured: 12 months of treatment
Secondary outcomes (3)
Patient-reported goal achievement for the most bothersome symptom using Likert scale
Measured: 3, 6, and 12 months of treatment
Changes in: IPSS, ICS-male questionnaire, maximal flow rate, post-voided residual urine, voiding chart parameters
Measured: 3, 6, and 12 months of treatment
Global impression of improvement
Measured: 3, 6, and 12 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study startDec 2005
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KYU-SUNG LEE, Samsung Medical Center
- Investigators
- Kyu-Sung Lee, Ph.D, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00836823
- Sponsor's protocol ID
- 2005-10-044
- Status last verified
- Oct 2023
- First submitted
- 2 Feb 2009
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21251673
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00836823
- Acronym / sponsor ID
- 2005-10-044
- Keywords
- Patient-reported most bothersome symptom, Patient-reported symptom-specific goal achievement, Medical treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 4 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alpha blocker | Experimental | Drug: AlfuzosinAlfuzosin 10mg |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (18 listed)
- Post voided residual urine ≥ 200mL
- Patients performing catheterization
- Urinary tract infection patients
- Patients taking 5 alpha reductase inhibitor
- Known hypersensitivity to alfuzosin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlfuzosinAlso: XATRAL XLAlfuzosin 10mg once daily for 12 months | Drug | Alpha blocker |
Primary outcome
Patient-reported goal achievements for the most bothersome symptoms
Time frame: 12 months of treatment
3 secondary outcomes
Patient-reported goal achievement for the most bothersome symptom using Likert scale
Time frame: 3, 6, and 12 months of treatment
Changes in: IPSS, ICS-male questionnaire, maximal flow rate, post-voided residual urine, voiding chart parameters
Time frame: 3, 6, and 12 months of treatment
Global impression of improvement
Time frame: 3, 6, and 12 months of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Derived from this study: PubMed 21251673Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyu-Sung Lee, Ph.D principal investigator
Samsung Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alfuzosin in people with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by Samsung Medical Center at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported goal achievements for the most bothersome symptoms (time frame: 12 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00836823, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.