Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms
Conditions
Interventions
Intervention1: Group-I (Tab Tadalafil 5mgs and Tab Dutasteride 0.5mgs): Tab Tadalafil 5mgs and Tab Dutasteride 0.5mgs to be taken orally each once a day at bed time after meals with sips of water for
Sponsors
University College of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. All patients aged >= 45 and informed consent to participate in the study. 2. Patients with clinical symptoms of BPH with no absolute indication for surgery 3. Patients with enlarged prostate gland ( >30gms) on clinical examination/ultrasound. 4. Patients with moderate to severe IPSS symptoms (IPSS Score > 8) 5. Patients with active untreated UTI. 6. Patients with newly diagnosed BPH but not on any medication for BPH /or stopped medications for the past 2 weeks.
Exclusion criteria
Exclusion criteria: 1. Patients with mental disorders or illness who cannot understand or comply with the study protocol. 2. BPH with secondary complications (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 dutasteride/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. 8. Any other disease or condition and any other systemic illness or disorder which in the clinical judgement of the investigator is/are deemed risky.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Efficacy outcome parameters will be assessed by (i) peak flow rate improvement (Objective),(ii) International prostatic symptom score (IPSS), (iii) Quality of life (QOL) & (iv) International Index of Erectile Function (IIEF-5)if feasible , all above will be done at each visit till 3 months as final endpoint (Subjective).Timepoint: 1, 2 and 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Safety outcome parameters will be assessed with monitoring of treatment emergent adverse drug events (TEAE) reactions/side effects, adverse events and serious adverse effects of the drugs being administered shall be documented as per our proforma along with assessment of derangement in any of our laboratory reports. Compliance will be assessed by collecting empty drug strips at each visitTimepoint: 1,2 and 3 months | — |
Countries
India
Contacts
Public ContactDr Deep Patel
University College of Medical Sciences University of Delhi and GTBH
Outcome results
None listed