The Long Term Effects of Alfuzosin(Xatral XL) in LUTS/BPH Patients: Evaluation of Voiding and Storage Function - Full Text View

Sponsor:	Asan Medical Center
Information provided by:	Asan Medical Center
ClinicalTrials.gov Identifier:	NCT00696761

Purpose

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	Intervention	Phase
BPH	Drug: alfuzosin	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy 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

Resource links provided by NLM:

MedlinePlus related topics: Urine and Urination

Drug Information available for: Alfuzosin hydrochloride Alfuzosin

U.S. FDA Resources

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:

Primary outcome; IPSS changes between 4 groups compared to baseline after 12 mo treatment [ Time Frame: 12months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes of ICS-male questionnaire, uroflowmetry, residual urine volume, and Patient's Global Impression of Improvement [ Time Frame: 3month, 6month, 12month ] [ Designated as safety issue: No ]

Enrollment:	234
Study Start Date:	May 2006
Study Completion Date:	August 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
group1: Active Comparator BOOI≥ 20, BCI≥ 100	Drug: alfuzosin 10mg, once daily, 12months
group2: Active Comparator BOOI≥ 20, BCI<100	Drug: alfuzosin 10mg, once daily, 12months
group 3: Active Comparator BOOI<20, BCI≥ 100)	Drug: alfuzosin 10mg, once daily, 12months
group 4: Active Comparator BOOI<20, BCI<100	Drug: alfuzosin 10mg, once daily, 12 months

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)

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Asan Medical Center ( Myung-Soo Choo, Professor )
Study ID Numbers:	L9990
Study First Received:	June 11, 2008
Last Updated:	September 10, 2008
ClinicalTrials.gov Identifier:	NCT00696761 History of Changes
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Asan Medical Center:

LUTS
BPH
bladder outlet obstruction
bladder contractility

Additional relevant MeSH terms:

Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Urinary Bladder Diseases
Physiological Effects of Drugs
Urethral Obstruction
Cardiovascular Agents
Adrenergic alpha-Antagonists

Antihypertensive Agents
Pharmacologic Actions
Alfuzosin
Urologic Diseases
Therapeutic Uses
Urethral Diseases
Urinary Bladder Neck Obstruction
Adrenergic Antagonists

ClinicalTrials.gov processed this record on November 05, 2009