A randomised, double blinder study comparing tamsulosin and placebo versus tamsulosin and tadalafil in male lower urinary tract symptoms

Lower urinary tract symptoms (LUTS) including voiding and/orstorage symptoms have increasing prevalence with aging and have a negativeimpact on quality of life. Epidemiologic and research data have shownincreasing association between erectile dysfunction (ED) and LUTS in ageing mendue to proposed common pathophysiologic pathways**.**

Benign prostatic enlargement with bladder outlet obstructionis the most common cause for LUTS and medical therapy for LUTS include alphablockers such as Tamsulosin with well established efficacy and adverse effectprofile.

Phosphodiesterase – 5 inhibitors (PDE-5i) are the currentfirst line treatment option in majority of men with erectile dysfunction due totheir efficacy and safety profile. Clinical research has shown that PDE-5i isbeneficial in LUTS with or without ED. Tadalafil 5mg is approved for the use ofLUTS with or without ED.

We propose to compare the improvement in subjective (usingstandard validated questionnaires for LUTS and ED) and objective (uroflowmetryand post void residual urine) symptoms between the established standard ofmedical therapy namely Tamsulosin with a combination of Tamsulosin andTadalafil.

 Structured Abstract

Introduction: Male lower urinary tractsymptoms and erectile dysfunction have increasing prevalence with aging andhave significant impact on quality of life. Both LUTS and ED have been linkedby epidemiological studies and proposed common pathophysiologic pathways.Phosphodiesterase 5 inhibitors (PDE 5i) have shown significant improvements inLUTS and ED in men affected by one or both conditions. The present study isbeing done to compare the established standard medical therapy namelytamsulosin with combination of tamsulosin and tadalfil (PDE 5 i) in male LUTSin the Indian population.

Aims and objectives: To compare tamsulosin andplacebo versus tamsulosin and tadalafil in male lower urinary tract symptoms

Materials and methods: After institutional reviewboard clearance, patients with lower urinary tract symptoms who satisfy theinclusion and exclusion criteria will be included in the study prospectivelyafter informed written consent. Patients already on medications (alphablockers) will be given a two week drug free washout period. History andphysical examination including abdominal examination and digital rectalexamination of the prostate will be carried out on all patients. Validatedquestionnaires namely International Prostatic Symptom Score (IPSS) andInternational Index of Erectile Function (IIEF) will be administered.Laboratory investigations including urinalysis, serum creatinine, lipidprofile, blood sugar levels, plain radiography of kidney, ureter and bladderand ultrasound abdomen and pelvis will be done. Uroflowmetry test to assesspeak flow rate (Qmax) and post voidal residual urine (PVR) will also be done.After the history, physical examination and laboratory tests, the patient willbe randomized into one of the two arms of the study. Any patient reported drugrelated side effect will be prospectively documented and necessary investigationsperformed. At a follow up of three months, IPSS and IIEF questionnaires willagain be administered and uroflowmetry study done. The two arms will becompared for improvements in subjective (IPSS) and objective (uroflowmetry)symptoms. Also the improvement in erectile function will be assessed using IIEFquestionnaire.

Primary outcome measure: IPSS

Secondary outcome measures: IPSS-Qol, IIEF, Qmax, PVR

Analysis**:**Quantitative datawill be analyzed by student’s t-test (unpaired) and qualitative data     by Fisher’s exact test.

Results: Results of the study will be published in Indexed Journal.