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Completed

NCT Number: NCT01301599

Comparison Between Alpha Blocker Monotherapy and 5ARI Monotherapy Following Combination Therapy in Benign Prostatic Hyperplasia (BPH)

This study is designed to investigate the comparison between alpha blocker monotherapy and 5-alpha-reductase inhibitor monotherapy following combination therapy in benign prostatic hyperplasia.

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Key information

Age range

45 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male aged 45 years old and above (with no upper limit of age)
  • patients who underwent combination therapy of alpha blocker and 5 ARI for more than 9 months
  • IPSS ≤ 12
  • Ability and willingness to correctly complete the micturition diary and questionnaire
  • Capable of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risks and benefits

Exclusion criteria

  • An anticholinergic or antidiuretic if started less than 3 months prior to screening
  • Patients who had surgical treatment due to LUTS
  • Patients with suspected neurogenic bladder disorder
  • Patients with cancer of any type including cancer of the prostate or bladder
  • Patients with urethral stricture or bladder neck contracture
  • Patients with suspicious chronic prostatitis/chronic pelvic pain syndrome
  • Acute bacterial prostatitis less than 6 months prior to screening
  • Symptomatic acute urinary tract infection (UTI) less than 1 months prior to screening
  • Patients who had underwent prostatic biopsy less than one month prior to screening
  • Patients who had unstable angina or cerebral vascular disease less than 6 months prior to screening

Treatment and study plan

Combination therapy

Drug

alpha blocker and 5-alpha-reductase inhibitor medication

alpha blocker monotherapy

Drug

alpha blocker monotherapy group

5 alpha reductase inhibitor monotherapy

Drug

5 alpha reductase inhibitor monotherapy

Primary outcomes

  1. Numeric change of IPS and Numeric change of IPSS total score

    Time frame: from baseline to 12 months of treatment

Secondary outcomes

  1. Changes in patients' symptom questionnaires : IPSS, ICIQ male LUTS

    Time frame: from baseline to 12 months of treatment

  2. Changes in urodynamic parameters : maximal flow rate and PVR

    Time frame: from baseline to 12 months of treatment

  3. change in finding of TRUS

    Time frame: from baseline to 12 months of treatment

  4. Numeric Change and percent change in PSA

    Time frame: from baseline to 12 months of treatment

  5. safety evaluation : incidence and severity of adverse events

    Time frame: 12 months of treatment

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

Comparison Between Alpha Blocker Monotherapy and 5-alpha-reductase Inhibitor Monotherapy Following Combination Therapy in Benign Prostatic Hyperplasia

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 23, 2011
Registry last updated
Dec 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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