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

NCT01301599 | Completed Phase 4 DMC

• 1 other identifier: 2009-09-024
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Benign Prostatic Hyperplasia

Keywords

Benign Prostatic Hyperplasia; alpha blocker; 5-alpha reductase inhibitor; combination therapy

Outcome Measures

Primary Outcomes (1)

• Numeric change of IPS and Numeric change of IPSS total score

  from baseline to 12 months of treatment

Secondary Outcomes (5)

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

  from baseline to 12 months of treatment

• Changes in urodynamic parameters : maximal flow rate and PVR

  from baseline to 12 months of treatment

• change in finding of TRUS

  from baseline to 12 months of treatment

• Numeric Change and percent change in PSA

  from baseline to 12 months of treatment

• safety evaluation : incidence and severity of adverse events

  12 months of treatment

Study Arms (3)

combination group

EXPERIMENTAL

combination therapy of alpha blocker and 5-alpha-reductase inhibitor medication

Drug: combination therapy

alpha blocker group

ACTIVE COMPARATOR

alpha blocker monotherapy

Drug: alpha blocker monotherapy

5 ARI group

ACTIVE COMPARATOR

5 alpha-reductase inhibitor group

Drug: 5 alpha reductase inhibitor monotherapy

Interventions

combination therapy DRUG

alpha blocker and 5-alpha-reductase inhibitor medication

combination group

alpha blocker monotherapy DRUG

alpha blocker monotherapy group

alpha blocker group

5 alpha reductase inhibitor monotherapy DRUG

5 alpha reductase inhibitor monotherapy

5 ARI group

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Combined Modality Therapy

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Kyu-Sung Lee, Ph.D

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

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: Professor

Study Record Dates

• First Submitted: February 21, 2011
• First Posted: February 23, 2011
• Study Start: January 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 2, 2019

Record last verified: 2019-11

Locations

KR (1)