Advanced Benefits of Alpha-blocker Monotherapy on Lower Urinary Tracts Symptoms(LUTS) Patients
- Conditions
- Benign Prostate Hyperplasia
- Interventions
- Registration Number
- NCT01736033
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
The purpose of this study is to evaluate the clinical efficacy of alpha-blocker monotherapy and alpha-blocker + 5-alpha reductase inhibitor combination therapy in benign prostate hyperplasia patients, and suggest guidelines of the combination therapy.
- Detailed Description
Even though it should be decided on patients cautiously under careful consideration about prostate volume, Prostate Specific Antigen(PSA) level, symptom score and maximum uroflow, recently the combination therapy of alpha-blocker and 5-alpha reductase inhibitor has been tried imprudently in Korea.
As a result of several clinical trials which had conducted overseas for releasing the combination drug of alpha-blocker and 5-alpha reductase inhibitor, the superiority of the combination therapy has been proved, however, plenty of patients still don't derive additional profit from it.
Therefore, in this study, the investigators anticipate to meet with meaningful results on the clinical efficacy of alpha-blocker monotherapy and alpha-blocker + 5-alpha reductase inhibitor combination therapy in Korean benign prostate hyperplasia patients, and provide guidelines of the combination therapy.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 545
- Male patients aged over 50
- Clinically diagnosed benign prostate hyperplasia(BPH)
- 8 ≤ IPSS ≤ 30
- 4 ml/sec ≤ Q max ≤ 15 ml/sec
- minimum voided volume ≥ 125 ml
- Post voided residual volume ≤ 250
- Volunteer who singed on informed consent documents
-
Past history of surgical procedure experience related to BPH
-
Past history of taking 5-alpha reductase inhibitor(5-ARI) within 6 months before screening, or for more than 12 months regardless of the point of time
-
Past history of taking alpha blocker within 2 weeks before screening
-
Past history of acute urinary retention within 3 months before screening
-
Serum PSA ≥ 10 ng/ml (but, in the case of 4 ng/ml ≤ PSA < 10 ng/ml, the patients can be included only if prostate cancer is excluded by prostate biopsy)
-
Anatomical abnormalities of lower urinary tracts(urethrostenosis, diverticulosis, bladder neck contracture)
-
Clinical status that affects voiding other than BPH(neurogenic bladder, Chronic Prostatitis/Chronic Pelvic Pain Syndrome, urinary infection, etc.)
-
Unstable and significant medical condition including below
- Unstable angina pectoris, myocardial infarction, cerebrovascular disease within 6 months before screening
- Past history of malignant tumor including skin basal cell carcinoma within 5 years before screening
- Medically uncontrollable diabetes mellitus, peptic ulcer disease
- Severe hepatic diseases
- Past history of renal failure or renal disease (serum creatinine > 1.4mg/dl)
- Condition expected serious adverse event due to the investigational drug
-
Other conditions considered not eligible for the trial upon investigator's judgement
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tamsulosin + Finasteride Finasteride Tamsulosin 0.2mg + Finasteride 5 mg daily until clinical progression Tamsulosin + Placebo Tamsulosin Tamsulosin 0.2mg + Placebo 5 mg daily until clinical progression Tamsulosin + Placebo Placebo Tamsulosin 0.2mg + Placebo 5 mg daily until clinical progression Tamsulosin + Finasteride Tamsulosin Tamsulosin 0.2mg + Finasteride 5 mg daily until clinical progression
- Primary Outcome Measures
Name Time Method Clinical Progression 1 & 2 months after baseline, and then every 3 months up to 4 years One of below
* Deterioration of the symptoms
* Acute urinary retention
* Renal failure
* Recurrent urinary tract infection
* Urinary incontinence
* Surgical procedure related to benign prostate hyperplasia
- Secondary Outcome Measures
Name Time Method Physical examination every 1 year up to 4 years Digital Rectal Exam, Breast exam
Male Sexual Health Questionnaire every 6 months up to 4 years International Consultation on Incontinence Modular Questionnaire(ICIQ) male LUTS-short form every 6 months up to 4 years Uroflowmetry every 6 months up to 4 years including Qmax, voided volume and post-void residual volume(PVR)
Global Response Assessment(GRA) every 1 year up to 4 years Adverse Events every visit up to 4 years International Prostate Symptom Score(IPSS) 1 & 2 months after baseline, and then every 3 months up to 4 years Prostate volume every 1 year up to 4 years PSA level every 1 year up to 4 years PSA level will be examined in the central laboratory and be reported to each center as an adjusted number. It is because PSA level tends to decrease to 50% of baseline after taking finasteride for 1\~4 years, so there is possibilities that the blindedness is broken with the actual result.
Blood Chemistry every 1 year up to 4 years including Sodium, Potassium, Glucose, Urea nitrogen, Creatinine, ASpartate Transaminase(AST), ALanine Transaminase(ALT), Total bilirubin
Trial Locations
- Locations (11)
Chungbuk National University Hospital
🇰🇷Cheongju, Chungbuk, Korea, Republic of
Eulji General Hospital
🇰🇷Seoul, Korea, Republic of
Hallym University Sacred Heart Hospital
🇰🇷Anyang, Gyeoggi, Korea, Republic of
Soon Chun Hyang University Hospital Bucheon
🇰🇷Bucheon, Gyeonggi, Korea, Republic of
Bucheon St. Mary's Hospital
🇰🇷Bucheon, Gyeonggi, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam, Gyeonggi, Korea, Republic of
Soon Chun Hyang University Hospital Cheonan
🇰🇷Cheonan, Chungnam, Korea, Republic of
Chonnam National University Hwasun Hospital
🇰🇷Hwasun, Jeonnam, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon, Gyeonggi, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of