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

NCT00696761 | Completed Phase 4 Results

• 1 other identifier: L9990
• Study Type: interventional
• Target: 232
• Locations: 0 countries
• Sites: N/A

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.

Conditions

BPH

Keywords

LUTS; BPH; bladder outlet obstruction; bladder contractility

Outcome Measures

Primary Outcomes (2)

• Primary Outcome; International Prostate Symptom Score Changes Between 4 Groups Compared to Baseline After 12 mo Treatment

  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

  12months

• Treatment Efficacy Was Analyzed by Validated Symptom Scores.

  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.

  12 month

Secondary Outcomes (3)

• Changes of International Continence Society (ICS)-Male Questionnaire (Voiding Sum)

  12months

• Changes of Peak Flow Rates on Uroflowmetry

  12 months

• Changes in Residual Urine Volumes

  12 months

Study Arms (4)

group1

ACTIVE COMPARATOR

Bladder outlet obstruction index(BOOI)≥ 20, Bladder contractility index(BCI)≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.

Drug: Alfuzosin

group2

ACTIVE COMPARATOR

BOOI≥ 20, BCI\<100 Alfuzosin was administered daily (10 mg) for 12 month.

Drug: Alfuzosin

group 3

ACTIVE COMPARATOR

BOOI\<20, BCI≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.

Drug: Alfuzosin

group 4

ACTIVE COMPARATOR

BOOI\<20, BCI\<100 Alfuzosin was administered daily (10 mg) for 12 month.

Drug: Alfuzosin

Interventions

Alfuzosin DRUG

10mg, once daily, 12months

Also known as: xatral

group1

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asan Medical Center: lead

MeSH Terms

Conditions

Urinary Bladder Neck Obstruction

Interventions

alfuzosin

Condition Hierarchy (Ancestors)

Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Male Urogenital Diseases

Limitations and Caveats

Patients were not divided into three groups according to the ICS nomogram (obstructed \[BOOI \<40\], equivocally obstructed (20 \<BOOI \<40), and unobstructed \[BOOI \<20\]).

Results Point of Contact

• Title: Kanghyon Song, Myung-Soo Choo, Kyu-Sung Lee, Ji-Yeon Han, Young-Suk Lee,
• Organization: the Department of Urology, Asan Medical Center, University of Ulsan College

mschoo@amc.seoul.kr

82-2-3010-3735

Study Officials

• Myung-Soo Choo, M.D., PhD

  From the Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: urology department

Study Record Dates

• First Submitted: June 11, 2008
• First Posted: June 13, 2008
• Study Start: May 1, 2006
• Primary Completion: July 1, 2008
• Study Completion: August 1, 2008
• Last Updated: February 17, 2021
• Results First Posted: March 4, 2014

Record last verified: 2021-02