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

• ClinicalTrials.gov Identifier: NCT00696761
• Recruitment Status: Completed
• First Posted: June 13, 2008
• Results First Posted: March 4, 2014
• Last Update Posted: February 17, 2021
• Sponsor: Asan Medical Center
• Information provided by (Responsible Party): Myung-Soo Choo, Asan Medical Center

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	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 (Clinical Trial)
• 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 2006
• Actual Primary Completion Date: July 2008
• Actual Study Completion Date: August 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 Name: xatral
Active Comparator: group2; BOOI≥ 20, BCI<100 Alfuzosin was administered daily (10 mg) for 12 month.	Drug: Alfuzosin; 10mg, once daily, 12months; Other Name: 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 Name: 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 Name: xatral

Outcome Measures

Primary Outcome Measures :

1. Primary Outcome; International Prostate Symptom Score Changes Between 4 Groups Compared to Baseline After 12 mo Treatment [ Time Frame: 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. [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 12 months ]
   Changes in residual urine volumes to measure the efficacy of alfuzosin 10mg at 12 months post-treatment.

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes 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 :
• 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

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

More Information

• Responsible Party: Myung-Soo Choo, urology department, Asan Medical Center
• ClinicalTrials.gov Identifier: NCT00696761
• Other Study ID Numbers: L9990
• First Posted: June 13, 2008
• Results First Posted: March 4, 2014
• Last Update Posted: February 17, 2021
• Last Verified: February 2021

Keywords provided by Myung-Soo Choo, 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; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Urological Agents