Comparison of the efficacy of Tadalafil , Toltrodine and Placebo in reduction of symptoms severity of women with Urgency,frequency syndrom / Overactive bladder
The main objective of our study is to investigate of efficacy of Tadalafil in reduction of symptoms severity of women that suffering from Overactive bladder syndrome. Method is triple blind randomized clinical trial. The study population is premenopausal women age ranged between 18 to 50 years old that referred to Female Urology Clinic of Tabriz University of Medical Sciences with first presentation of urgency with or without incontinence. Exclusion criteria included of urine culture positive, abnormal ultrasonography, diabetes, any identified neurologic disorders and previous medical therapy. After explaining the research objectives of the study and informed consent, patients will be enrolled. The study will be conducted with a sample size of 90 subjects. The main interventions include the use of oral tadalafil tablets and two control groups by Tolterodine and Placebo are involved. Data collection is ICIQ-OAB questionnaire that validated in Persian. Symptoms severity of patients before and after four weeks of treatment is measured by the questionnaire. Reduction in symptoms severity after 4 weeks of treatment is considered as the primary outcome.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013030212668N1
Registration date:2013-05-21, 1392/02/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-05-21, 1392/02/31
Registrant information
Name
Reza Sari motlagh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1545 1054
Email address
motlagh.reza.dr@gmail.com
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2013-02-19, 1391/12/01
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of Tadalafil , Toltrodine and Placebo in reduction of symptoms severity of women with Urgency,frequency syndrom / Overactive bladder
Public title
Effect of Tadalafil in treatment of Overactive bladder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Female with urgency with or without urge incontinence; First presentation of disease; Nonmenpause; Age range between 18 and 50 years old. Exclusion criteria: Previous medication therapy; Abnormal ultrasonography of kidneys,ureters and bladder; Positive urine cultur; Diabetes; Identified norologic disorders; Age less than 18 years old; Age greater than 50 years old; Menopause.
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht st. , Tabriz
City
Tabriz
Postal code
Approval date
2013-01-26, 1391/11/07
Ethics committee reference number
91189
Health conditions studied
1
Description of health condition studied
overactive bladder syndrom
ICD-10 code
N32.8
ICD-10 code description
Bladder contracted
Primary outcomes
1
Description
Reduction of the symptoms severity
Timepoint
Before and 4 weeks after treatment
Method of measurement
ICIQ-OAB questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Tolterodine, Tab. 2 mg Oral, q12h for 4 weeks