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

• Sponsor: Asan Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00696761
• Collaborator: (none)
• Enrollment: 232
• Arms: 4
• Duration (Months): 27

Study Details

Study Description

Brief 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.

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.

Condition or Disease	Intervention/Treatment	Phase
BPH	Drug: Alfuzosin; Drug: Alfuzosin; Drug: Alfuzosin; Drug: Alfuzosin	Phase 4

Detailed Description

1. 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

2. 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

• Study Type: Interventional
• Actual Enrollment: 232 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: May 1, 2006
• Actual Primary Completion Date: Jul 1, 2008
• Actual Study Completion Date: Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: group1 Bladder outlet obstruction index(BOOI)≥ 20, Bladder contractility index(BCI)≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.	Drug: Alfuzosin; 10mg, once daily, 12months; Other Names: xatral
Active Comparator: group2 BOOI≥ 20, BCI<100 Alfuzosin was administered daily (10 mg) for 12 month.	Drug: Alfuzosin; 10mg, once daily, 12months; Other Names: xatral
Active Comparator: group 3 BOOI<20, BCI≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.	Drug: Alfuzosin; 10mg, once daily, 12months; Other Names: xatral
Active Comparator: group 4 BOOI<20, BCI<100 Alfuzosin was administered daily (10 mg) for 12 month.	Drug: Alfuzosin; 10mg, once daily, 12months; Other Names: xatral

Outcome Measures

Primary Outcome Measures

1. 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

2. 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 Outcome Measures

1. 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.

2. 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.

3. Changes in Residual Urine Volumes [12 months]

   Changes in residual urine volumes to measure the efficacy of alfuzosin 10mg at 12 months post-treatment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

• 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Asan Medical Center

Investigators

• Principal Investigator: Myung-Soo Choo, M.D., PhD, From the Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Myung-Soo Choo, urology department, Asan Medical Center
• ClinicalTrials.gov Identifier: NCT00696761
• Other Study ID Numbers: L9990
• First Posted: Jun 13, 2008
• Last Update Posted: Feb 17, 2021
• Last Verified: Feb 1, 2021

• Keywords provided by Myung-Soo Choo, urology department, Asan Medical Center: LUTS; BPH; bladder outlet obstruction; bladder contractility
• Additional relevant MeSH terms: Urinary Bladder Neck Obstruction; Alfuzosin

Study Results

Participant Flow

Recruitment Details	Participants recruited from a specialty clinic at the Asan Medical Center, Samsung Medical Center,The Catholic University of Korea College of Medicine, Hallym University, Chuncheon, Korea for 12-month
Pre-assignment Detail	232 participants recruited; 276 screened, 44 excluded

Arm/Group Title	BOOI≥20, BCI≥ 100	BOOI≥20, BCI< 100	BOOI<20, BCI≥ 100	BOOI<20, BCI< 100
Arm/Group Description	Bladder outlet obstruction index(BOOI)≥ 20, bladder contractility index (BCI)≥ 100 alfuzosin : 10mg, once daily, 12months	BOOI≥ 20, BCI<100 alfuzosin : 10mg, once daily, 12months	BOOI<20, BCI≥ 100) alfuzosin : 10mg, once daily, 12months	BOOI<20, BCI<100 alfuzosin : 10mg, once daily, 12 months
Period Title: Overall Study
STARTED	61	76	41	54
COMPLETED	41	50	30	44
NOT COMPLETED	20	26	11	10

Baseline Characteristics

Arm/Group Title	Group 3	Group 4	group1	group2	Total
Arm/Group Description	BOOI<20, BCI≥ 100) alfuzosin : 10mg, once daily, 12months	BOOI<20, BCI<100 alfuzosin : 10mg, once daily, 12 months	BOOI≥ 20, BCI≥ 100 alfuzosin : 10mg, once daily, 12months	BOOI≥ 20, BCI<100 alfuzosin : 10mg, once daily, 12months	Total of all reporting groups
Overall Participants	41	54	61	76	232
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	10 24.4%	10 18.5%	10 16.4%	10 13.2%	40 17.2%
>=65 years	31 75.6%	44 81.5%	51 83.6%	66 86.8%	192 82.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.0 (2.0)	67.4 (0)	66.0 (1.2)	63.1 (5)	65.7 (7.3)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%	0 0%	0 0%
Male	41 100%	54 100%	61 100%	76 100%	232 100%
Region of Enrollment (participants) [Number]
Korea, Republic of	41 100%	54 100%	61 100%	76 100%	232 100%
international prostate symptom score (scores) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [scores]	18.9 (7.6)	18.8 (6.8)	19.4 (6.9)	21.0 (6.5)	19.5 (6.95)

Outcome Measures

1. Primary Outcome

Title	Primary Outcome; International Prostate Symptom Score Changes Between 4 Groups Compared to Baseline After 12 mo Treatment
Description	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
Time Frame	12months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BOOI≥ 20, BCI≥100	BOOI≥ 20, BCI<100	BOOI<20, BCI≥ 100	BOOI<20, BCI<100
Arm/Group Description	Bladder outlet obstruction index(BOOI)≥ 20, Bladder contractility index(BCI)≥ 100 Alfuzosin was administered daily (10 mg) for 12 month. alfuzosin: 10mg, once daily, 12months	BOOI≥ 20, BCI<100 Alfuzosin was administered daily (10 mg) for 12 month. alfuzosin: 10mg, once daily, 12months	BOOI<20, BCI≥ 100 Alfuzosin was administered daily (10 mg) for 12 month. alfuzosin: 10mg, once daily, 12months	BOOI<20, BCI<100 Alfuzosin was administered daily (10 mg) for 12 month. alfuzosin: 10mg, once daily, 12 months
Measure Participants	41	50	30	44
Mean (Standard Deviation) [score]	13.0 (6.6)	12.0 (5.4)	10.6 (6.1)	13.4 (6.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BOOI≥ 20, BCI≥100, BOOI≥ 20, BCI<100, BOOI<20, BCI≥ 100, BOOI<20, BCI<100
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Kruskal-Wallis
	Comments

2. Primary Outcome

Title	Treatment Efficacy Was Analyzed by Validated Symptom Scores.
Description	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.
Time Frame	12 month

Outcome Measure Data

Analysis Population Description

The population analyzed included participants receiving drug for 12 months

Arm/Group Title	Group 3	Group 4	group1	group2
Arm/Group Description	BOOI<20, BCI≥ 100) alfuzosin : 10mg, once daily, 12months	BOOI<20, BCI<100 alfuzosin : 10mg, once daily, 12 months	BOOI≥ 20, BCI≥ 100 alfuzosin : 10mg, once daily, 12months	BOOI≥ 20, BCI<100 alfuzosin : 10mg, once daily, 12months
Measure Participants	30	44	41	50
Mean (Standard Deviation) [score]	8.3 (6.2)	6.4 (6.2)	6.4 (6.5)	9.0 (6.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BOOI≥ 20, BCI≥100, BOOI≥ 20, BCI<100, BOOI<20, BCI≥ 100, BOOI<20, BCI<100
	Comments	The Kruskal-Wallis test, analysis of variance, and the Wilcoxon signed rank-sum test were used to compare changes from baseline to endpoint after treatment.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Kruskal-Wallis
	Comments

3. Secondary Outcome

Title	Changes of International Continence Society (ICS)-Male Questionnaire (Voiding Sum)
Description	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.
Time Frame	12months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	group1	group2	Group 3	Group 4
Arm/Group Description	Bladder outlet obstruction index(BOOI)≥ 20, Bladder contractility index(BCI)≥ 100 Alfuzosin was administered daily (10 mg) for 12 month. Alfuzosin: 10mg, once daily, 12months	BOOI≥ 20, BCI<100 Alfuzosin was administered daily (10 mg) for 12 month. Alfuzosin: 10mg, once daily, 12months	BOOI<20, BCI≥ 100 Alfuzosin was administered daily (10 mg) for 12 month. Alfuzosin: 10mg, once daily, 12months	BOOI<20, BCI<100 Alfuzosin was administered daily (10 mg) for 12 month. Alfuzosin: 10mg, once daily, 12months
Measure Participants	41	50	30	44
Mean (Standard Deviation) [score on a scale]	8.2 (4.3)	7.2 (3.4)	9.7 (6.4)	8.2 (4.1)

4. Secondary Outcome

Title	Changes of Peak Flow Rates on Uroflowmetry
Description	Changes of peak flow rates on uroflowmetry to measure the efficacy of alfuzosin 10mg at 12 months post-treatment.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	group1	group2	Group 3	Group 4
Arm/Group Description	Bladder outlet obstruction index(BOOI)≥ 20, Bladder contractility index(BCI)≥ 100 Alfuzosin was administered daily (10 mg) for 12 month. Alfuzosin: 10mg, once daily, 12months	BOOI≥ 20, BCI<100 Alfuzosin was administered daily (10 mg) for 12 month. Alfuzosin: 10mg, once daily, 12months	BOOI<20, BCI≥ 100 Alfuzosin was administered daily (10 mg) for 12 month. Alfuzosin: 10mg, once daily, 12months	BOOI<20, BCI<100 Alfuzosin was administered daily (10 mg) for 12 month. Alfuzosin: 10mg, once daily, 12months
Measure Participants	41	50	30	44
Mean (Standard Deviation) [ml/s]	14.3 (7.2)	10.9 (6.4)	16.8 (8.7)	13.0 (5.3)

5. Secondary Outcome

Title	Changes in Residual Urine Volumes
Description	Changes in residual urine volumes to measure the efficacy of alfuzosin 10mg at 12 months post-treatment.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	group1	group2	Group 3	Group 4
Arm/Group Description	Bladder outlet obstruction index(BOOI)≥ 20, Bladder contractility index(BCI)≥ 100 Alfuzosin was administered daily (10 mg) for 12 month. Alfuzosin: 10mg, once daily, 12months	BOOI≥ 20, BCI<100 Alfuzosin was administered daily (10 mg) for 12 month. Alfuzosin: 10mg, once daily, 12months	BOOI<20, BCI≥ 100 Alfuzosin was administered daily (10 mg) for 12 month. Alfuzosin: 10mg, once daily, 12months	BOOI<20, BCI<100 Alfuzosin was administered daily (10 mg) for 12 month. Alfuzosin: 10mg, once daily, 12months
Measure Participants	41	50	30	44
Mean (Standard Deviation) [ml]	51.6 (87)	37 (45.2)	29.3 (35.9)	31.7 (35.3)

Adverse Events

Arm/Group Title	Group 3		Group 4		group1		group2
Arm/Group Description	BOOI<20, BCI≥ 100) alfuzosin : 10mg, once daily, 12months		BOOI<20, BCI<100 alfuzosin : 10mg, once daily, 12 months		BOOI≥ 20, BCI≥ 100 alfuzosin : 10mg, once daily, 12months		BOOI≥ 20, BCI<100 alfuzosin : 10mg, once daily, 12months
All Cause Mortality
	Group 3		Group 4		group1		group2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Group 3		Group 4		group1		group2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/54 (0%)		0/61 (0%)		0/76 (0%)
Other (Not Including Serious) Adverse Events
	Group 3		Group 4		group1		group2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/41 (4.9%)		2/54 (3.7%)		2/61 (3.3%)		3/76 (3.9%)
Vascular disorders
dizziness	2/41 (4.9%)	2	2/54 (3.7%)	2	2/61 (3.3%)	2	3/76 (3.9%)	3

Limitations/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]).

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.