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

This study has been completed.

Sponsor:

Information provided by:

Asan Medical Center

ClinicalTrials.gov Identifier:

NCT00696761

First received: June 11, 2008

Last updated: June 22, 2011

Last verified: June 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	June 11, 2008
Last Updated Date	June 22, 2011
Start Date ^ICMJE	May 2006
Primary Completion Date	July 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 12, 2008)	Primary outcome; IPSS changes between 4 groups compared to baseline after 12 mo treatment [ Time Frame: 12months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00696761 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 12, 2008)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Long Term Effects of Alfuzosin(Xatral XL) in LUTS/BPH Patients: Evaluation of Voiding and Storage Function
Official Title ^ICMJE	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
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.
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 Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	BPH
Intervention ^ICMJE	Drug: alfuzosin 10mg, once daily, 12months Other Name: xatral Drug: alfuzosin 10mg, once daily, 12 months Other Name: xatral
Study Arm (s)	Active Comparator: group1 BOOI≥ 20, BCI≥ 100 Intervention: Drug: alfuzosin Active Comparator: group2 BOOI≥ 20, BCI<100 Intervention: Drug: alfuzosin Active Comparator: group 3 BOOI<20, BCI≥ 100) Intervention: Drug: alfuzosin Active Comparator: group 4 BOOI<20, BCI<100 Intervention: Drug: alfuzosin
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	234
Completion Date	August 2008
Primary Completion Date	July 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Male
Ages	50 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00696761
Other Study ID Numbers ^ICMJE	L9990
Has Data Monitoring Committee	No
Responsible Party	Myung-Soo Choo, Professor, Asan Medical Center
Study Sponsor ^ICMJE	Asan Medical Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Asan Medical Center
Verification Date	June 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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