Role of Tadalafil & Dutasteride combination for prostate enlargement.

Not Applicable

Conditions: Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms

Registration Number: CTRI/2019/11/021991

Lead Sponsor: niversity College of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. All patients aged >= 45 and <80 years giving

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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