The Long Term Effects of Alfuzosin(Xatral XL) in LUTS/BPH Patients: Evaluation of Voiding and Storage Function
This study has been completed.
Sponsor:
Asan Medical Center
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00696761
First received: June 11, 2008
Last updated: June 22, 2011
Last verified: June 2008
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
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 |
|---|---|
|
Active Comparator: group1
BOOI≥ 20, BCI≥ 100
|
Drug: alfuzosin
10mg, once daily, 12months
Other Name: xatral
|
|
Active Comparator: group2
BOOI≥ 20, BCI<100
|
Drug: alfuzosin
10mg, once daily, 12months
Other Name: xatral
|
|
Active Comparator: group 3
BOOI<20, BCI≥ 100)
|
Drug: alfuzosin
10mg, once daily, 12months
Other Name: xatral
|
|
Active Comparator: group 4
BOOI<20, BCI<100
|
Drug: alfuzosin
10mg, once daily, 12 months
Other Name: xatral
|
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: | Myung-Soo Choo, Professor, Asan Medical Center |
| ClinicalTrials.gov Identifier: | NCT00696761 History of Changes |
| Other Study ID Numbers: | L9990 |
| Study First Received: | June 11, 2008 |
| Last Updated: | June 22, 2011 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Asan Medical Center:
|
LUTS BPH bladder outlet obstruction bladder contractility |
Additional relevant MeSH terms:
|
Urinary Bladder Neck Obstruction Urethral Obstruction Urethral Diseases Urologic Diseases Urinary Bladder Diseases Alfuzosin Antihypertensive Agents Cardiovascular Agents Therapeutic Uses |
Pharmacologic Actions Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013