BPHPhase 4NCT00696761

The Long Term Effects of Alfuzosin(Xatral XL) in Lower Urinary Tract Symptoms(LUTS)/BPH Patients

A Phase 4 study testing Alfuzosin in people with BPH, run by Asan Medical Center.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Benign prostatic hyperplasia (BPH) is a common condition among older men. The efficacy of α1-blockers for treating BPH has been well documented and they are recommended for the treatment of BPH by clinical guidelines. Read more about this study

Who is it for?: Ages 50 years and older, men only
Conditions the study is for: BPH
What is being tested?: Alfuzosin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 232 participants
Where: No sites listed yet
Study dates: May 2006to Aug 2008
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Ambulatory males (≥50 years) suffering from LUTS suggestive of BPH
Patients satisfying all of the following:
Moderate to severe LUTS :
international prostate symptom score (IPSS)≥ 8
An enlarged prostate (≥25 mL)
Decreased peak flow rate : Qmax ≤15 mL/s (volume voided ≥ 120 mL)

Who cannot join

Post voided residual urine ≥ 200 mL
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 (Aspartate transaminase /alanine aminotransferase ≥ 2 times of normal range)
Renal insufficiency (s-Cr ≥ 2mg/dL)
Unstable angina pectoris
Uninvestigated hematuria
Serum Prostate specific antigen ≥ 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

About this study

Official title: The Long Term Effects of Alfuzosin(Xatral XL) in LUTS/BPH Patients: Evaluation of Voiding and Storage Function According to Bladder Outlet Obstruction Grade and Bladder Contractility

It is not well known if a stratification based on the grade of BOO and bladder contractility has any predictive value for patients who are treated with an α1-selective blocking agent. In our study, we investigated possible differences in treatment outcome between patients with and without BOO, and with or without proper contractility who are treated with alfuzosin. So we will compare the quantified improvements 12 months after alfuzosin medication in LUTS/BPH patients by the grade of BOO and/or bladder contractility.

Read the detailed description

Primary objective To evaluate efficacy on voiding and storage symptoms in LUTS/BPH patients after 12 months of treatment with Xatral XL® by the grade of bladder outlet obstruction and/or bladder contractility
Secondary objectives To evaluate efficacy on voiding and storage symptoms in LUTS/BPH patients after 3 months and 6 months of treatment with Xatral XL® by the grade of bladder outlet obstruction and/or bladder contractility To evaluate efficacy on maximal flow rate (MFR) and post-voided residual urine (PVR) To evaluate on voiding frequency, urgency severity \& frequency, and nocturia To evaluate patient tolerability to the medication To evaluate global impression of improvement (GII)

Conditions: BPH
Being tested: Alfuzosin
Keywords: LUTS, BPH, bladder outlet obstruction, bladder contractility
Medical subject headings: Urinary Bladder Neck Obstruction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AlfuzosinDrug
Also called xatral
10mg, once daily, 12months
AlfuzosinDrug
Also called xatral
10mg, once daily, 12months
AlfuzosinDrug
Also called xatral
10mg, once daily, 12months
AlfuzosinDrug
Also called xatral
10mg, once daily, 12months

Study groups in NCT00696761
Study group	Role	What they receive
group1	Active comparator	Bladder outlet obstruction index(BOOI)≥ 20, Bladder contractility index(BCI)≥ 100 Alfuzosin was administered daily (10 mg) for 12 month. Receives: Drug: Alfuzosin
group2	Active comparator	BOOI≥ 20, BCI<100 Alfuzosin was administered daily (10 mg) for 12 month. Receives: Drug: Alfuzosin
group 3	Active comparator	BOOI<20, BCI≥ 100 Alfuzosin was administered daily (10 mg) for 12 month. Receives: Drug: Alfuzosin
group 4	Active comparator	BOOI<20, BCI<100 Alfuzosin was administered daily (10 mg) for 12 month. Receives: Drug: Alfuzosin

What is being measured

The primary outcome is the main question the study is designed to answer.

Primary Outcome; International Prostate Symptom Score Changes Between 4 Groups Compared to Baseline After 12 mo Treatment
international prostate symptom score was measured at baseline and 12 months. total scores on a scale range (from 0 to 35) higher values represent a worse outcome
Baseline score minus 12-month score
Measured: 12months
Treatment Efficacy Was Analyzed by Validated Symptom Scores.
Alfuzosin was administered daily (10 mg). After 12 months of treatment, efficacy and safety were analyzed. Efficacy was measured by validated symptom scores (using IPSS ). IPSS score change was measured pre- and post- treatment.
Measured: 12 month

Secondary outcomes (3)

Changes of International Continence Society (ICS)-Male Questionnaire (Voiding Sum)
Changes of International Continence Society (ICS)-male questionnaire (voiding sum) to measure the efficacy of alfuzosin 10mg at 12 months post-treatment.
Range 0-20, higher scores represent worse outcomes.
Measured: 12months
Changes of Peak Flow Rates on Uroflowmetry
Changes of peak flow rates on uroflowmetry to measure the efficacy of alfuzosin 10mg at 12 months post-treatment.
Measured: 12 months
Changes in Residual Urine Volumes
Changes in residual urine volumes to measure the efficacy of alfuzosin 10mg at 12 months post-treatment.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2006Aug 2008

First posted13 Jun 2008 (estimated)
Study startMay 2006
Primary completionJul 2008
Study completionAug 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for BPHStudies of the same condition, open and under way.
More trials run by Asan 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 232 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00696761
Sponsor's protocol ID: L9990
Status last verified: Feb 2021
First submitted: 11 Jun 2008
Last updated: 17 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign

All BPH trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Feb 2021. 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 Voiding and Storage Function According to Bladder Outlet Obstruction Grade and Bladder Contractility
ClinicalTrials.gov ID: NCT00696761
Acronym / sponsor ID: L9990
Conditions: BPH
Keywords: LUTS, BPH, bladder outlet obstruction, bladder contractility
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 232 participants (actual)
Lead sponsor: Asan Medical CenterUniversity, hospital or other
Study start: May 2006
Primary completion: Jul 2008 (actual)
Study completion: Aug 2008 (actual)
First posted: 13 Jun 2008 (estimated)
Results: Posted 4 Mar 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Primary objective To evaluate efficacy on voiding and storage symptoms in LUTS/BPH patients after 12 months of treatment with Xatral XL® by the grade of bladder outlet obstruction and/or bladder contractility
Secondary objectives To evaluate efficacy on voiding and storage symptoms in LUTS/BPH patients after 3 months and 6 months of treatment with Xatral XL® by the grade of bladder outlet obstruction and/or bladder contractility To evaluate efficacy on maximal flow rate (MFR) and post-voided residual urine (PVR) To evaluate on voiding frequency, urgency severity \& frequency, and nocturia To evaluate patient tolerability to the medication To evaluate global impression of improvement (GII)

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
group1	Active comparator	Drug: AlfuzosinBladder outlet obstruction index(BOOI)≥ 20, Bladder contractility index(BCI)≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.
group2	Active comparator	Drug: AlfuzosinBOOI≥ 20, BCI<100 Alfuzosin was administered daily (10 mg) for 12 month.
group 3	Active comparator	Drug: AlfuzosinBOOI<20, BCI≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.
group 4	Active comparator	Drug: AlfuzosinBOOI<20, BCI<100 Alfuzosin was administered daily (10 mg) for 12 month.

Who may qualify

Ages: 50 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Ambulatory males (≥50 years) suffering from LUTS suggestive of BPH
Patients satisfying all of the following:
Moderate to severe LUTS :
international prostate symptom score (IPSS)≥ 8
An enlarged prostate (≥25 mL)

Key exclusion criteria (18 listed)

Post voided residual urine ≥ 200 mL
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: xatral10mg, once daily, 12months	Drug	group1
AlfuzosinAlso: xatral10mg, once daily, 12months	Drug	group2
AlfuzosinAlso: xatral10mg, once daily, 12months	Drug	group 3
AlfuzosinAlso: xatral10mg, once daily, 12months	Drug	group 4

Primary outcome

Primary Outcome; International Prostate Symptom Score Changes Between 4 Groups Compared to Baseline After 12 mo Treatment
Time frame: 12months
international prostate symptom score was measured at baseline and 12 months. total scores on a scale range (from 0 to 35) higher values represent a worse outcome Baseline score minus 12-month score
Treatment Efficacy Was Analyzed by Validated Symptom Scores.
Time frame: 12 month
Alfuzosin was administered daily (10 mg). After 12 months of treatment, efficacy and safety were analyzed. Efficacy was measured by validated symptom scores (using IPSS ). IPSS score change was measured pre- and post- treatment.

3 secondary outcomes

Changes of International Continence Society (ICS)-Male Questionnaire (Voiding Sum)
Time frame: 12months
Changes of Peak Flow Rates on Uroflowmetry
Time frame: 12 months
Changes in Residual Urine Volumes
Time frame: 12 months

Results and safety

Results posted to the registry on 4 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BOOI≥20, BCI≥ 100	61	41
BOOI≥20, BCI< 100	76	50
BOOI<20, BCI≥ 100	41	30
BOOI<20, BCI< 100	54	44

Primary outcome: Primary Outcome; International Prostate Symptom Score Changes Between 4 Groups Compared to Baseline After 12 mo Treatment

Time frame: 12months. Mean (Standard Deviation). Unit: score

Measure	BOOI≥ 20, BCI≥100 n = 41	BOOI≥ 20, BCI<100 n = 50	BOOI<20, BCI≥ 100 n = 30	BOOI<20, BCI<100 n = 44
Value	13.0 (6.6)	12.0 (5.4)	10.6 (6.1)	13.4 (6.3)

BOOI≥ 20, BCI≥100 vs BOOI≥ 20, BCI<100 vs BOOI<20, BCI≥ 100 vs BOOI<20, BCI<100: p <0.05, Kruskal-Wallis

Primary outcome: Treatment Efficacy Was Analyzed by Validated Symptom Scores.

Time frame: 12 month. Mean (Standard Deviation). Unit: score

Measure	Group 3 n = 30	Group 4 n = 44	group1 n = 41	group2 n = 50
Value	8.3 (6.2)	6.4 (6.2)	6.4 (6.5)	9.0 (6.1)

Group 3 vs Group 4 vs group1 vs group2: p <0.05, Kruskal-Wallis

Population analysed: The population analyzed included participants receiving drug for 12 months

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 3.9% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 3	0 of 41 (0%)	2 of 41 (4.9%)	Not reported
Group 4	0 of 54 (0%)	2 of 54 (3.7%)	Not reported
group1	0 of 61 (0%)	2 of 61 (3.3%)	Not reported
group2	0 of 76 (0%)	3 of 76 (3.9%)	Not reported

Limitations and caveats (from the sponsor): Patients were not divided into three groups according to the ICS nomogram (obstructed \[BOOI \<40\], equivocally obstructed (20 \<BOOI \<40), and unobstructed \[BOOI \<20\]).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for BPH

Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign

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.

Myung-Soo Choo, M.D., PhD principal investigator

From the Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Alfuzosin in people with BPH, run by Asan Medical Center.

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 6 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 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 4 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Primary Outcome; International Prostate Symptom Score Changes Between 4 Groups Compared to Baseline After 12 mo Treatment (time frame: 12months). The study lists 2 primary outcomes in all. 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 NCT00696761.

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 17 Feb 2021.