Lower urinary tract symptoms (LUTS) including voiding and/or storage symptoms have increasing prevalence with aging and have a negative impact on quality of life. Epidemiologic and research data have shown increasing association between erectile dysfunction (ED) and LUTS in ageing men due to proposed common pathophysiologic pathways.

Benign prostatic enlargement with bladder outlet obstruction is the most common cause for LUTS and medical therapy for LUTS include alpha blockers such as Tamsulosin with well established efficacy and adverse effect profile.

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

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

Structured Abstract

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

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

Materials and methods: After institutional review board clearance, patients with lower urinary tract symptoms who satisfy the inclusion and exclusion criteria will be included in the study prospectively after informed written consent. Patients already on medications (alpha blockers) will be given a two week drug free washout period. History and physical examination including abdominal examination and digital rectal examination of the prostate will be carried out on all patients. Validated questionnaires namely International Prostatic Symptom Score (IPSS) and International Index of Erectile Function (IIEF) will be administered. Laboratory investigations including urinalysis, serum creatinine, lipid profile, blood sugar levels, plain radiography of kidney, ureter and bladder and ultrasound abdomen and pelvis will be done. Uroflowmetry test to assess peak flow rate (Qmax) and post voidal residual urine (PVR) will also be done. After the history, physical examination and laboratory tests, the patient will be randomized into one of the two arms of the study. Any patient reported drug related side effect will be prospectively documented and necessary investigations performed. At a follow up of three months, IPSS and IIEF questionnaires will again be administered and uroflowmetry study done. The two arms will be compared for improvements in subjective (IPSS) and objective (uroflowmetry) symptoms. Also the improvement in erectile function will be assessed using IIEF questionnaire.

Primary outcome measure: IPSS

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

Analysis: Quantitative data will 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.