Trial · NCT00696761

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

NCT00696761, Phase 4, Completed, Asan Medical Center; results first posted 2014-03-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. The Long Term Effects of Alfuzosin(Xatral XL) in Lower Urinary Tract Symptoms(LUTS)/BPH Patients. Trials, record NCT00696761. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00696761

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: The Long Term Effects of Alfuzosin(Xatral XL) in Lower Urinary Tract Symptoms(LUTS)/BPH Patients
NCT number: NCT00696761
Status: Completed
Phases: Phase 4
Enrollment: 232 participants, actual
Lead sponsor: Asan Medical Center
Conditions: BPH
Interventions: Alfuzosin, Alfuzosin, Alfuzosin, Alfuzosin
First posted: 2008-06-13
Last updated: 2021-02-17
Results first posted: 2014-03-04
Limitations and caveats: Patients were not divided into three groups according to the ICS nomogram (obstructed \[BOOI \<40\], equivocally obstructed (20 \<BOOI \<40), and unobstructed \[BOOI \<20\]).

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Primary Outcome; International Prostate Symptom Score Changes Between 4 Groups Compared to Baseline After 12 mo Treatment	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
Primary	Treatment Efficacy Was Analyzed by Validated Symptom Scores.	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.
Secondary	Changes of International Continence Society (ICS)-Male Questionnaire (Voiding Sum)	12months	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.
Secondary	Changes of Peak Flow Rates on Uroflowmetry	12 months	Changes of peak flow rates on uroflowmetry to measure the efficacy of alfuzosin 10mg at 12 months post-treatment.
Secondary	Changes in Residual Urine Volumes	12 months	Changes in residual urine volumes to measure the efficacy of alfuzosin 10mg at 12 months post-treatment.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Primary Outcome; International Prostate Symptom Score Changes Between 4 Groups Compared to Baseline After 12 mo Treatment	12months		score	MEAN
PRIMARY	Treatment Efficacy Was Analyzed by Validated Symptom Scores.	12 month	The population analyzed included participants receiving drug for 12 months	score	MEAN
SECONDARY	Changes of International Continence Society (ICS)-Male Questionnaire (Voiding Sum)	12months		score on a scale	MEAN
SECONDARY	Changes of Peak Flow Rates on Uroflowmetry	12 months		ml/s	MEAN
SECONDARY	Changes in Residual Urine Volumes	12 months		ml	MEAN

Source ClinicalTrials.gov

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Primary Outcome; International Prostate Symptom Score Changes Between 4 Groups Compared to Baseline After 12 mo Treatment	BOOI≥ 20, BCI≥100	13.0	Standard Deviation 6.6	score
Primary Outcome; International Prostate Symptom Score Changes Between 4 Groups Compared to Baseline After 12 mo Treatment	BOOI≥ 20, BCI<100	12.0	Standard Deviation 5.4	score
Primary Outcome; International Prostate Symptom Score Changes Between 4 Groups Compared to Baseline After 12 mo Treatment	BOOI<20, BCI≥ 100	10.6	Standard Deviation 6.1	score
Primary Outcome; International Prostate Symptom Score Changes Between 4 Groups Compared to Baseline After 12 mo Treatment	BOOI<20, BCI<100	13.4	Standard Deviation 6.3	score
Treatment Efficacy Was Analyzed by Validated Symptom Scores.	Group 3	8.3	Standard Deviation 6.2	score
Treatment Efficacy Was Analyzed by Validated Symptom Scores.	Group 4	6.4	Standard Deviation 6.2	score
Treatment Efficacy Was Analyzed by Validated Symptom Scores.	group1	6.4	Standard Deviation 6.5	score
Treatment Efficacy Was Analyzed by Validated Symptom Scores.	group2	9.0	Standard Deviation 6.1	score
Changes of International Continence Society (ICS)-Male Questionnaire (Voiding Sum)	group1	8.2	Standard Deviation 4.3	score on a scale
Changes of International Continence Society (ICS)-Male Questionnaire (Voiding Sum)	group2	7.2	Standard Deviation 3.4	score on a scale

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	BOOI≥20, BCI≥ 100	61
Overall Study	STARTED	BOOI≥20, BCI< 100	76
Overall Study	STARTED	BOOI<20, BCI≥ 100	41
Overall Study	STARTED	BOOI<20, BCI< 100	54
Overall Study	COMPLETED	BOOI≥20, BCI≥ 100	41
Overall Study	COMPLETED	BOOI≥20, BCI< 100	50
Overall Study	COMPLETED	BOOI<20, BCI≥ 100	30
Overall Study	COMPLETED	BOOI<20, BCI< 100	44
Overall Study	NOT COMPLETED	BOOI≥20, BCI≥ 100	20
Overall Study	NOT COMPLETED	BOOI≥20, BCI< 100	26

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events4

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	dizziness	Vascular disorders	Group 3	2	41	2
other	dizziness	Vascular disorders	Group 4	2	54	2
other	dizziness	Vascular disorders	group1	2	61	2
other	dizziness	Vascular disorders	group2	3	76	3

Source ClinicalTrials.gov

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Group 3
Total, all-cause mortality	Group 4
Total, all-cause mortality	group1
Total, all-cause mortality	group2
Total, other adverse events	Group 3	2	41
Total, other adverse events	Group 4	2	54
Total, other adverse events	group1	2	61
Total, other adverse events	group2	3	76
Total, serious adverse events	Group 3	0	41
Total, serious adverse events	Group 4	0	54

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00696761

GET https://conductscience.org/api/trials/v1/NCT00696761/registered

API reference For AI assistants