A study to assess whether a combination of tadalafil with tamsulosin is better than tamsulosin alone in the treatment of male lower urinary tract symptoms

Phase 3

Not yet recruiting

• Conditions: Male lower urinary tract symptoms

• Registration Number: CTRI/2015/09/006226
• Lead Sponsor: Sun Pharma limited Sun Urology

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-10
• Last Update Posted: 2015-09-28

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Male
• Target Recruitment: 120

Inclusion Criteria

1. Men more than 45 years with LUTS 2) International Prostate Symptom Score (IPSS) between 8 to 19 (moderate symptoms) 3) IPSS quality of life score 4 or more (bothersome LUTS) 4) Qmax (peak flow rate) between 5 and 15 ml/second 5) Willing to consent and take medications for the study duration.

Exclusion Criteria

• 1. Carcinoma prostate 2) LUTS due to other causes such as stricture urethra 3) Absolute indications for surgery.
• hematuria, recurrent urinary tract infection, bladder calculus, renal dysfunction and acute urinary retention 4) IPSS >19 (severe symptoms) 5) Post void residual urine >300ml 6) Already on 5 alpha reductase inhibitors treatment 7) On nitrate drugs 8) Other comorbid illness/cardiac condition contraindicating use of phosphodiesterase inhibitors 9) Unwilling to consent or take medications for the study period.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
International Prostate Symptom Score (IPSS)	International Prostate Symptom Score (IPSS) will be assessed at baseline (zero months) and at three months of follow up

Secondary Outcome Measures

Name	Time	Method
1)IPSS Qol (Quality of life score)	2)International Index of Erectile Function (IIEF score)

Trial Locations

Locations (1)

Department of Urology (OPD and LUTS clinic), Christian Medical College, Vellore; 🇮🇳 Vellore, TAMIL NADU, India

Department of Urology (OPD and LUTS clinic), Christian Medical College, Vellore

🇮🇳Vellore, TAMIL NADU, India

Santhosh Nagasubramanian

Principal investigator

sannags@gmail.com