Evaluation and comparison of the effect of Tadalafil and placebo on nighttime frequency refractory to treatment with alfa-adrenergic inhibitors in males with LUTS/BPH referred to Razi Hospital
Nocturnal frequency or nocturia is one of the most common and challengeable complaints related to lower urinary tract symptom (LUTS). Nocturia is to arise one or more at night to void. Nocturia affects quality of life and health of patients.
This study is a pilot randomized double blind control trial that would be conducted in Razi Educational Hospital on 100 men with nocturia due to LUTS/BPH. Patients randomly based on randomized blocks with sequence 4 divided in two groups of 50; one group received tadalafil 5mg daily plus tamsulosin 0.4 mg daily as a treatment for LUTS and the other group received tamsulosin 0.4mg daily plus placebo.
The patients will visit at weeks of 2, 4, 8 and 12, again. At each visit, frequency of urination during the night would be asked and recorded, IPSS questionnaire will be completed to assess symptoms of prostate and uroflowmetry will be performed. PSA test and ultrasound of the kidneys and bladder and calculate urinary residues would be done before and after treatment. Blinding for both groups (for both study subjects and study information analysis and monitoring committee) will be carried out.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201208091853N9
Registration date:2016-05-13, 1395/02/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-13, 1395/02/24
Registrant information
Name
Siavash Falahatkar
Name of organization / entity
Urology Research Center
Country
Iran (Islamic Republic of)
Phone
+98 13 3352 5259
Email address
urc@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Urology Research Center, Guilan University of Medical Sciences
Expected recruitment start date
2014-08-06, 1393/05/15
Expected recruitment end date
2015-08-06, 1394/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of the effect of Tadalafil and placebo on nighttime frequency refractory to treatment with alfa-adrenergic inhibitors in males with LUTS/BPH referred to Razi Hospital
Public title
The effect of Tadalafil on night time frequency refractory to treatment with alfa-adrenergic inhibitors
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: age above 50, refractory LUTS to life style change such as: quite smoking and limit consumption of liquid alcohol and caffeine before sleeping, having moderate physical activity. Exclusion criteria: BMI above 30kg/m2, surgery indication for BPH, urinary residual above 200CC, chronic pelvic pain syndrome (CPPS) over active bladder (OAB) urethral or bladder stone, history of pervious neurogenic bladder ureteral or bladder stone history of urethral bladder or prostate malignancy, PSA above 4 ng/ml or PSA between 4-10 ng/ml with positive biopsy for prostate malignancy, active urinary tract infection (UTI) or active sexual transmitted disease (STD)
Age
From 50 years old to 149 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
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 Guilan University of Medical Sciences
Street address
Opposite Sepah Bank, Western Shahid Beheshti Blvd., Gaz Square
City
Rasht
Postal code
41938-93345
Approval date
2014-06-02, 1393/03/12
Ethics committee reference number
1930111208
Health conditions studied
1
Description of health condition studied
Nocturnal frequency or nocturia
ICD-10 code
R35
ICD-10 code description
Polyuria
Primary outcomes
1
Description
Nocturia
Timepoint
2, 4, 8 and 12 weeks after intervention
Method of measurement
Examination and evaluation by Night Time Voiding Diary, SPSS and Quality of Life score questionnaires, and uroflowmetry (Maximum Flow Rate or Qmax)
Secondary outcomes
empty
Intervention groups
1
Description
tadalafil 5mg, daily for 12 weeks
Made in Iran
Category
Treatment - Drugs
2
Description
placebo, daily for 12 weeks
Made in Iran
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Dr. Keivan Gholamjani Moghaddam (supervisor)
Street address
Sardar Jangal Street, Razi hospital
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Guilan University of Medical Sciences
Full name of responsible person
Investigator
Street address
Sardar Jangal Street, Razi hospital, Urology Research Centre
City
Rasht
Grant name
10506
Grant code / Reference number
32
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Dr. Keivan Gholamjani Moghadam
Position
Co worker/General Physician
Other areas of specialty/work
Street address
Razi Hospital, Sardar Jangal Street
City
Rasht
Postal code
41448-95655
Phone
+98 13 3352 5259
Fax
Email
urc1384@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urology Research Center
Full name of responsible person
Dr. Siavash Falahatkar
Position
Proffesor of Guilan University of Medical Sciences
Other areas of specialty/work
Street address
Urology Research Center, Razi Hospital, Sardar Jangal Street
City
Rasht
Postal code
41448-95655
Phone
+98 13 3352 5259
Fax
Email
urc1384@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Urology Research Center
Full name of responsible person
Samaneh Esmaeili
Position
Master/Research Expert
Other areas of specialty/work
Street address
Urology Research Center, Razi Hospital
City
Rasht
Postal code
41448-95655
Phone
+98 13 3352 5259
Fax
Email
urc1384@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)