Evaluation of the selective cyclooxygenase-2 inhibitor and non-selective cyclooxygenase inhibitor in benign prostatic hyperplasia

Not Applicable

• Conditions: Benign prostate hyperplasia.; Hyperplasia of prostate

• Registration Number: IRCT2017091836241N2
• Lead Sponsor: Deputy of Research of Azad University of Pharmaceutical Sciences

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: 60

Inclusion Criteria

Men over the age of 50 who have moderate to severe benign prostatic hyperplasia with international prostate symptoms score greater than 8; benign prostate diagnosis; no Liver problem; no active infections; no history of frequent urinary tract infections; no clear malignancy; no stone in the urethra, ureter and bladder; no history of urolithiasis; no prostate transurethral removal; no history of inflammation of the prostate; absence of a microscopy hematuria and advanced; no history of or retention; no history of trauma of the lower back and perineal and urethra; no history of cystoscopy; no history of sexually transmitted infections; no history of pelvic or urological surgery; non diabetic; non-neurological diseases (CNA, Parkinson's disease, MS and lumbar disks); history of congestive heart failure; no history of pelvic radiotherapy; no history of tuberculosis; no renal failure with creatinine higher than 1.3; no history of antidepressants, antihistamines, bronchodilators, diuretics and narcotics in the last 3 months; no history of psychological diseases (such as Schizopherenia, severe depression); lack of experience in the use of effective drugs in the treatment of benign prostatic hypertrophy in the last 3 months, including 5a-alpha-reductates and alpha-blockers, and phosphodiesterase inhibitors; no history of persistent alcohol and caffeine intake; high fluid intake; gastrointestinal ulcer or gastrointestinal bleeding.
Exclusion criteria: Patient disagreement; unwillingness to follow up the study program for any reason; sensitivity to the drug and its ingredients? the use of the drug causes patient dissatisfaction; the acute urinary problems so that the person has urinary retention and the condition is so severe that it requires catheterization and surgery; prostate cancer

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
International Prostate Symptom Score. Timepoint: Before intervention and 3 months after start of intervention. Method of measurement: questionnaire.;Quality of life. Timepoint: Before intervention and 3 months after start of intervention. Method of measurement: questionnaire.

Secondary Outcome Measures

Name	Time	Method
Prostate Specific Antigen. Timepoint: Before intervention and 3 months after start of intervention. Method of measurement: Blood test.;Prostate Volume. Timepoint: Before intervention and 3 months after start of intervention. Method of measurement: Abdominal ultrasound.;Post-Void Residual Urine Volume. Timepoint: Before intervention and 3 months after start of intervention. Method of measurement: Abdominal ultrasound.