A Prospective Randomized Controlled Trial Assessing the Efficacy of Withdrawing Alpha-blocker Following Initial Combination Therapy with 5-Alpha Reductase Inhibitor for Benign Prostatic Hyperplasia

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000853842

Enrollment

102

Registered

2012-08-14

Start date

2010-01-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Combination therapy of alpha-blocker and 5-alpha-reductase inhibitor (5ARI) is effective for the treatment of benign prostate hyperplasia (BPH) but it is costly. This study aimed to assess the efficacy of withdrawing alpha-blocker following initial combination therapy with 5ARI.

Interventions

Tablet dutasteride 0.5mg daily, oral, 3 months

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

Male

Age

40 Years to 80 Years

Healthy volunteers

Inclusion criteria

patients with moderate or severe BPH based on IPSS score who were newly diagnosed and started on combination therapy or who were previously diagnosed and were already on combination therapy for a duration of not more than one year. All patients on combination therapy had a prostate size of more than 40g as assessed by digital rectal examination

Exclusion criteria

All patients had a baseline PSA taken routinely and patients with a value higher than 4ng/ml underwent biopsy to screen for possible malignancy. Patients with PSA value less than 1.5ng/ml, prostate cancer and patients with recurrent urinary tract infections were excluded from our study.

Outcome results