Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms
Conditions
Interventions
Intervention1: Tadalafil Group: Male patients with LUTS who receive Tadalafil add on therapy along with alpha Blocker with or without Dutasteride for 12 months
Control Intervention1: Non tadalafil gr
Sponsors
AIIMS Bhubaneswar
Eligibility
Inclusion criteria
Inclusion criteria: Consented male patients aged 18 years and above who present to Urology OPD with BPE and LUTS
Exclusion criteria
Exclusion criteria: Patients not giving informed consent 2. Patients with urethral stricture disease 3. Patients with vesical or ureteric calculi 4. Patients with known hypersensitivity to tadalafil 5. Patients receiving Nitric Oxide supplying agents like Nitroglycerin, Isosorbide dinitrate etc. 6. Patients with unstable angina, heart failure, poorly controlled cardiac arrhythmia and hypertension 7. Patients with history of myocardial infarction within 3 months 8. Patients with history of cerebro-vascular accident within 6 months 9. Child-Pugh class C hepatic dysfunction 10. Chronic Kidney Disease patients with eGFR less than 30 ml per min per 1.73m2 11. Patients with angle closure glaucoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the serum IL-6, IL-8, IL-17, IL-18 levels at baseline and at one month follow-up among male BPE patients with LUTS with or without tadalafil add-on therapy. Timepoint: 12 months post initiation of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| • To compare improvements in IPSS, OABSS and IIEF-5 scores at baseline and at one month follow-up among male BPE patients with LUTS with or without tadalafil add-on therapy.Timepoint: 12 months post initiation of therapy | — |
Countries
India
Contacts
Public ContactKalandi Barik
AIIMS Bhubaneswar
Outcome results
None listed