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

The efficacy of combination therapy with "Tamsulosin and Meloxicam” for the management of Lower Urinary Tract Symptoms suggestive of Benign Prostatic HyperplasiaL: a randomized double-blind placebo–control clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201009304582N4

Enrollment

Registered

2010-11-13

Start date

2010-07-23

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention 1: 0.4mg tamsulosin daily and placebo daily for 3 months. Intervention 2: 0.4mg tamsulosin daily and 15mg meloxicam daily for 3 months.

Placebo

Treatment - Drugs

0.4mg tamsulosin daily and placebo daily for 3 months

0.4mg tamsulosin daily and 15mg meloxicam daily for 3 months

Eligibility

Sex/Gender

Male

Age

50 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: - age between 50 to 80 years old - Patients with LUTS - International Prostate Symptom Score (IPSS)= 12 - 5ml/s 10mg/ml - Post Void Residue (PVR)= 200ml - side effects of Meloxicam consumption - acute urinary retention during treatment - side effects of Tamsulosin consumption.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Side effects of meloxicam. Timepoint: 3 months. Method of measurement: questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Alireza Farzan

Urology Research Center

farzan_alireza@yahoo.com; urc1384@yahoo.com+98 13 1552 5259

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026