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Effectiveness of pregabalin as an adjuvant therapy for chronic nonbacterial prostatitis

Protocol summary

Summary
Objective: To determine the effectiveness of pregabalin as an adjuvant therapy for chronic nonbacterial prostatitis. Design: A double-blind block randomized clinical trial. Study population: Male patients with chronic nonbacterial prostatitis. Inclusion criteria: 1) Age over 18 years; 2) no prior history of other urinary system disorders such as urinary tract stones, neurogenic bladder, and urinary infections; 3) no history of major underlying diseases such as cirrhosis, renal failure, diabetes, or hypertension; 4) normal levels of urine, fasting blood sugar (FBS), and creatinine; 5) normal results on the first neurological examination of the perineal area, lower limbs, lower limb reflexes, and bulbocavernosus reflex; 6) no use of other medicines; 7) no signs of psychological disorders; 8) confirmed diagnosis of chronic prostatitis; 9) non-sensitivity to anti-epileptic drugs, pregabalin, thiazolidinediones, or other anti-diabetic agents. Exclusion criteria: 1) Unwillingness to continue the study, and 2) major side-effects due to the use of medications. Sample size: 288 cases. Study intervention: Use of terazosin tablets (2 mg) and pregabalin capsules (50 mg) on a daily basis for the first week, followed by the daily use of 100 mg pregabalin capsules for six weeks. Study outcome: Evaluation and comparison of pain, urinary symptoms, quality of life, and side-effects of medications between the intervention and control groups, based on the scoring system introduced by the National Institute of Health-Chronic Prostatitis Symptom Index (NIH-CPSI).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016022225507N2
Registration date: 2016-03-01, 1394/12/11
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-03-01, 1394/12/11
Registrant information
Name
Ali Serous
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 4499
Email address
m-jiriaie@mscstu.scu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Arak University of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of pregabalin as an adjuvant therapy for chronic nonbacterial prostatitis
Public title
Effectiveness of pregabalin on chronic nonbacterial prostatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1) Age over 18 years; 2) no prior history of other urinary system disorders such as urinary tract stones, neurogenic bladder, and urinary infections; 3) no history of major underlying diseases such as cirrhosis, renal failure, diabetes, or hypertension; 4) normal levels of urine, fasting blood sugar (FBS), and creatinine; 5) normal results on the first neurological examination of the perineal area, lower limbs, lower limb reflexes, and bulbocavernosus reflex; 6) no use of other medicines; 7) no signs of psychological disorders; 8) confirmed diagnosis of chronic prostatitis; 9) non-sensitivity to anti-epileptic drugs, pregabalin, thiazolidinediones, or other anti-diabetic agents. Exclusion criteria: 1) Unwillingness to continue the study, and 2) major side-effects due to the use of medications.
Age
From 18 years old to 139 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 288
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
Ethics Committee of Arak University of Medical Sciences
Street address
Vice Chancellor for Research, Arak University of Medical Sciences, A'lam-Al-Hoda Street, Shahid Shiroodi Street
City
Arak
Postal code
Approval date
2015-01-26, 1393/11/06
Ethics committee reference number
93-174-11

Health conditions studied

1

Description of health condition studied
Chronic nonbacterial prostatitis
ICD-10 code
N41.8
ICD-10 code description
Other inflammatory diseases of prostate

Primary outcomes

1

Description
Rang of pain
Timepoint
6 weeks after therapy
Method of measurement
NIH-CPSI scoring system, Scoring from 0 to 21

Secondary outcomes

1

Description
Urinary symptoms
Timepoint
6 weeks after therapy
Method of measurement
NIH-CPSI scoring system, Scoring from 0 to 10

Intervention groups

1

Description
Control group: Patients with chronic nonbacterial prostatitis use of Terazosin tablets (2 mg) and placebo capsules (50 mg) on a daily basis for the first week, followed by the daily use of 100 mg placebo capsules for six weeks, measurement of pain, and urinary symptoms after therapy.
Category
Treatment - Drugs

2

Description
Intervention group: Patients with chronic nonbacterial prostatitis use of terazosin tablets (2 mg) and pregabalin capsules (50 mg) on a daily basis for the first week, followed by the daily use of 100 mg pregabalin capsules for six weeks., measurement of pain, and urinary symptoms after therapy
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Ali Sirous
Street address
Valiasr Hospital-Perozi Avenue
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Arak University of Medical Sciences
Full name of responsible person
Ali Asghar Yaghobi
Street address
Vice Chancellor for Research, Arak University of Medical Sciences, A'lam-Al-Hoda Street,Shahid Shiroodi Street
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Arak University of Medical Sciences
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
Arak University of Medical Sciences
Full name of responsible person
Ali Sirous
Position
Urologist
Other areas of specialty/work
Street address
Arak University of Medical Sciences, A'lam-Al-Hoda Street, Shahid Shiroodi Street
City
Arak
Postal code
Phone
+98 86 3313 6058
Fax
Email
m-jiriaie@mscstu.scu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ali Sirous
Position
Urologist
Other areas of specialty/work
Street address
Arak University of Medical Sciences, A'lam-Al-Hoda Street, Shahid Shiroodi Street
City
Arak
Postal code
Phone
+98 86 3313 6058
Fax
Email
m-jiriaie@mscstu.scu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ali Sirous
Position
Urologist
Other areas of specialty/work
Street address
Arak University of Medical Sciences, A'lam-Al-Hoda Street, Shahid Shiroodi Street
City
Arak
Postal code
Phone
+98 86 3313 6058
Fax
Email
m-jiriaie@mscstu.scu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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