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
Inflammation and inflammatory mediators have an important role in the pathophysiology of benign prostatic hyperplasia (BPH) and lower urinary tract symptoms (LUTS). We will assess the efficacy of administration of combination therapy with “Tamsulosin and Meloxicam” with “Tamsulosin and placebo” in the management of LUTS suggestive of BPH. In our study which is a randomized double- blind placebo –control clinical trial, 44 men aged 50 to 80 years with LUTS suggestive of BPH will be enrolled. They randomly will be allocated in two groups. One group receives Tamsulosin 0.4mg/daily and Meloxicam 15mg/daily and another group receives Tamsulosin 0.4mg/daily and Placebo once daily. We assess the difference of International Prostate Symptom Score (IPSS), maximum of urinary flow rate (Qmax) and Post Void Residue (PVR) before treatment and 3 months after that.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201009304582N4
Registration date:2010-11-13, 1389/08/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-11-13, 1389/08/22
Registrant information
Name
Ali Hamidi Madani
Name of organization / entity
Urology Research Center, Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1552 5259
Email address
hamidimadani@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Urology Research Center of Guilan University of Medical Sciences
Expected recruitment start date
2010-07-23, 1389/05/01
Expected recruitment end date
2010-10-22, 1389/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
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
Purpose
Treatment
Inclusion/Exclusion criteria
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.
Age
From 50 years old to 80 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Research Assisstant of Guilan University of Medical Sciences
Street address
The Research Assisstant of Guilan University of Medical Sciences
City
Rasht
Postal code
Approval date
2010-05-22, 1389/03/01
Ethics committee reference number
1023
Health conditions studied
1
Description of health condition studied
Lower Urinary Tract Symptoms
ICD-10 code
N21
ICD-10 code description
Calculus of lower urinary tract
2
Description of health condition studied
Benign Prostatic Hyperplasia
ICD-10 code
N40
ICD-10 code description
Hyperplasia of prostate
Primary outcomes
1
Description
variations of International Prostate Symptom Scor (IPSS)
Timepoint
3 months
Method of measurement
IPSS questaionnaire
2
Description
variations of Qmax
Timepoint
3 months
Method of measurement
uroflometery
3
Description
variations of Post Voided Residue (PVR)
Timepoint
3 months
Method of measurement
Sonography
Secondary outcomes
1
Description
Side effects of meloxicam
Timepoint
3 months
Method of measurement
questionnaire
Intervention groups
1
Description
0.4mg tamsulosin daily and placebo daily for 3 months
Category
Placebo
2
Description
0.4mg tamsulosin daily and 15mg meloxicam daily for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Urology Clinic of Razi Hospital
Full name of responsible person
Dr. Alireza Farzan
Street address
Razi Hospital
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Urology Research Center
Full name of responsible person
Dr. Siavash Falahatkar, Manager of Urology Research Center
Street address
Urology Research Center, Razi Hospital
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urology Research Center
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Urology Research Center
Full name of responsible person
Dr. Alireza Farzan
Position
Coworker/Resident of Urology
Other areas of specialty/work
Street address
Urology Research Center, Razi Hospital
City
Rasht
Postal code
4144895655
Phone
+98 13 1552 5259
Fax
+98 13 1552 5259
Email
farzan_alireza@yahoo.com; urc1384@yahoo.com
Web page address
www.urc.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urology Research Center
Full name of responsible person
Dr. Ali Hamidi Madani
Position
Assisstant Prof.
Other areas of specialty/work
Street address
Urology Research Center, Razi Hospital
City
Rasht
Postal code
4144895655
Phone
+98 13 1552 5259
Fax
+98 13 1552 5259
Email
a42hamidi2000@yahoo.com; urc1384@yahoo.com
Web page address
www.urc.ir
Person responsible for updating data
Contact
Name of organization / entity
Urology Research Center
Full name of responsible person
Samaneh Esmaeili
Position
Urology Research Center secreter/ Bachlor
Other areas of specialty/work
Street address
Urology Research Cente, Razi Hospital
City
Rasht
Postal code
4144895655
Phone
+98 13 1552 5259
Fax
+98 13 1552 5259
Email
samaneh_815@yahoo.com; urc1384@yahoo.com
Web page address
www.urc.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)