Tadalafil add-on therapy in reducing systemic inflammatory markers and alleviating clinical symptoms in patients with symptomatic Benign Prostatic Enlargement: An open-labelled randomized clinical trial.

Open label randomized parallel group clinical trial at AIIMS Bhubaneswar in the Departments of Urology and Biochemistry. Adult men with benign prostatic enlargement and lower urinary tract symptoms will be enrolled after consent. Participants will be randomized by computer using sealed envelopes to two groups. Intervention group: standard therapy with an alpha blocker with or without dutasteride plus tadalafil five milligrams once daily. Control group: standard therapy with an alpha blocker with or without dutasteride without tadalafil. Follow up is one month. Primary outcome is change in serum inflammatory markers interleukin 6, interleukin 8, interleukin 17, and interleukin 18 from baseline to one month. Secondary outcomes are change in symptom scores IPSS, OABSS, IIEF 5 and uroflowmetry measures including Qmax voided volume and post void residual. Adverse events will be actively monitored and managed as per a predefined plan. Sample size is sixty two total with thirty one per arm. Total study duration is twelve months after ethics approval and CTRI registration. Study aim is to test whether tadalafil add on reduces systemic inflammation and improves symptoms in this population.