comparision of the efficacy of solifenazine with doloxetine in the treatment of overactive bladder in women referred to Besat clinic of kerman
Design
Clinical trial, with parallel groups, single blind, No randomization
Settings and conduct
Overactive bladder disease status and drug side effects that the evaluator does not know the type of drug the population of the study is women referring to Kerman Beatitudes Clinic with urinary frequency more than 5-6 times per day at less than 1 hour intervals
Participants/Inclusion and exclusion criteria
Inclusion criteria are: All women had urinary frequency more than six times a day at intervals less than one hour
Exclusion criteria are:
urinary tract infection, diabetes, under 18 years old, BMI greater than 35, smokers, having bladder stones , pervious surgical history
Intervention groups
Intervention group: anti-cholinergic drug name is Soli-phenazine 10 mg daily for 4 week
Control group: Serotonin reuptake inhibitor norepinephrine duloxetine 20 mg daily for 4 week
Main outcome variables
Bladder disease status and drug side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191010045047N1
Registration date:2019-12-19, 1398/09/28
Registration timing:registered_while_recruiting
Last update:2019-12-19, 1398/09/28
Update count:0
Registration date
2019-12-19, 1398/09/28
Registrant information
Name
salar dozchizade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3626 6165
Email address
salardozchizade@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-17, 1398/07/25
Expected recruitment end date
2020-03-18, 1398/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the efficacy of solifenacin with duloxetine in the treatment of overactive bladder disease in women
Public title
Comparison of the efficacy of solifenacin and duloxetine in the treatment of overactive bladder disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All women had urinary frequency more than six times a day at intervals less than one hour
Exclusion criteria:
urinary tract infection
diabetes
under 18 years old
BMI greater than 35
smokers
having bladder stones
previous surgical history
Age
From 18 years old
Gender
Female
Phase
2
Groups that have been masked
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The present study was a single-blind clinical trial study
The evaluator does not know the type of drug
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of kerman medical university
Street address
Emam highway pardise afzalipoor the afzalipoor hospital
City
kerman
Province
Kerman
Postal code
۷۶۱۶۹۱۳۹۱۱
Approval date
2019-09-30, 1398/07/08
Ethics committee reference number
IR.KMU.AH.REC.1398.099
Health conditions studied
1
Description of health condition studied
over active bladder
ICD-10 code
N32.81
ICD-10 code description
other specified disorders of bladder
Primary outcomes
1
Description
Patients symptoms of OAB
Timepoint
First of trial and one month later
Method of measurement
International consultation on incontinence questionnaire
2
Description
Drug side effects
Timepoint
One month later
Method of measurement
Patient history
Secondary outcomes
empty
Intervention groups
1
Description
intervention Group 1: 10mg daily anti-cholinergic solifenacin drug made by abidi Pharmaceutical Company for a month
Category
Treatment - Drugs
2
Description
Intervention group2: Serotonin norepinephrine reuptake inhibitor Duloxetine 20 mg daily by abidi Pharmaceutical Company for a month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Beast clinic
Full name of responsible person
Mahbobe mirzaei
Street address
Somayeh intersection (Tahmasb Abad), next to the old Kerman hospital
City
kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 1677
Email
salardozchizade@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas pardakhti
Street address
isar blvd,yaghot2,plaque13
City
kerman
Province
Kerman
Postal code
٧٦١٧٩٤٣٣٨٨
Phone
+98 44 3626 6165
Email
salardozchizade @gmail.com
Grant name
0
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mahbobe mirzaei
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Qarni St, Hospital Bahonar Department of Urology
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3222 1600
Email
mirzaeimahboubeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mahbube mirzaei
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Qarni St, Hospital Bahonar Department of Urology
City
kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3222 1600
Email
mirzaeimahboubeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mahbube mirzaei
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Qarni St, Hospital Bahonar Department of Urology
City
kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3222 1600
Email
mirzaeimahboubeh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available