The assessment of the efficacy of combination therapy with Tamsulosin and Meloxicam” for the management of Lower Urinary Tract Symptoms suggestive of Benign Prostatic Hyperplasia

Phase 3

• Conditions: Condition 1: Lower Urinary Tract Symptoms. Condition 2: Benign Prostatic Hyperplasia.; Calculus of lower urinary tract; Hyperplasia of prostate

• Registration Number: IRCT201009304582N4
• Lead Sponsor: rology Research Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 44

Inclusion Criteria

age between 50 to 80 years old - Patients with LUTS - International Prostate Symptom Score (IPSS)= 12 - 5ml/s < maximum of urinary flow rate (Qmax) < 15 ml/s - volume of prostate less than 50ml. Exclusion criteria: - prostate cancer - history of previous surgery of prostate - liver disease - bleeding diathesis - history of Gastrointestinal Bleeding (GIB) or Peptic Ulcer Disease (PUD) - Prostate Specific Antigen (PSA) > 10mg/ml - Post Void Residue (PVR)= 200ml - side effects of Meloxicam consumption - acute urinary retention during treatment - side effects of Tamsulosin consumption.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Variations of International Prostate Symptom Scor (IPSS). Timepoint: 3 months. Method of measurement: IPSS questaionnaire.;Variations of Qmax. Timepoint: 3 months. Method of measurement: uroflometery.;Variations of Post Voided Residue (PVR). Timepoint: 3 months. Method of measurement: Sonography.

Secondary Outcome Measures

Name	Time	Method
Side effects of meloxicam. Timepoint: 3 months. Method of measurement: questionnaire.