Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms Health Condition 2: null- Lower urinary tract symptoms(LUTS), Benign Prostatic Hypertrophy (BPH)
Conditions
Interventions
Intervention1: Tablet Tadalafil: 5mgs tablet to be taken orally Once a day at bed time after meals for 2 months.
Control Intervention1: Tab Tamsulosin hydrochloride.: 0.4 mgs tablet to be taken orally
Sponsors
University College of Medical Sciences University of Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged >= 45 years upto 80 years giving informed consent to participate in the study. 2. Patients with clinical symptoms of BPH without absolute and or any urgent indication for surgery. 3. Symptomatic patients with enlarged prostate gland documented with either clinical examination or by ultrasound. 4. Patients without clinical or investigatory evidence of UTI. 5. Patients newly diagnosed with BPH . 6. Patients with diagnosed BPH but not on any medication or stopped medications for the past 2 weeks. 7. Patients of BPH with IPSS Score >7.
Exclusion criteria
Exclusion criteria: 1. Patients with mental disorders or illness who cannot understand or comply with the study protocol. 2. Patients of BPH with secondary complications due to BPH (like CRF, hydronephrosis, acute bacterial prostatitis, hematuria). 3. Patients with LUTS/BOO due to causes other than BPH (neurogenic causes). 4. Patients with known drug allergy/contraindications to tamsulosin/ tadalafil. 5. Patients taking nitrates for angina pectoris, CYP3A4 inhibitors (ketoconazole, ritonavir) and CYP3A4 inducers (rifampin). 6. Patients with previous history of prostate surgery. 7. Cancer prostate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EFFICACY OUTCOME: 1.IPSS 2. QOL Index scores 3. UROFLOW parameters 4. Post void residual vol, 5. IIEF-5 Score. SAFETY OUTCOME: 1. Adverse drug reactions 2.side effects, 3. Adverse events of the drug(s) being administered 4. Biochemical lab reports. COMPLIANCE: Compliance to the administered therapy will be assessed by asking the patient to bring the empty strips consumed in the last 30 days. Timepoint: 2 months | — |
Secondary
| Measure | Time frame |
|---|---|
| IIEF-5 scoreTimepoint: 2 months | — |
Countries
India
Contacts
Public ContactDr Aravind TK
University College of Medical Sciences University of Delhi
Outcome results
None listed