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

A

Asan Medical Center

Status and phase

Completed
Phase 4

Conditions

BPH

Treatments

Drug: Alfuzosin

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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)

Enrollment

232 patients

Sex

Male

Ages

50+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

232 participants in 4 patient groups

group1
Active Comparator group
Description:
Bladder outlet obstruction index(BOOI)≥ 20, Bladder contractility index(BCI)≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.
Treatment:
Drug: Alfuzosin
group2
Active Comparator group
Description:
BOOI≥ 20, BCI<100 Alfuzosin was administered daily (10 mg) for 12 month.
Treatment:
Drug: Alfuzosin
group 3
Active Comparator group
Description:
BOOI<20, BCI≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.
Treatment:
Drug: Alfuzosin
group 4
Active Comparator group
Description:
BOOI<20, BCI<100 Alfuzosin was administered daily (10 mg) for 12 month.
Treatment:
Drug: Alfuzosin

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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