The Comparison Between Traditional Iranian Medicine Product Consist of "Myrtus Communis" with "Toltrodine" in Control of Urge Urinary Incontinence in Women
1) Objectives: Investigate the efficacy of an Iranian Traditional Medicine product consist of "Myrtus Communis" with "Toltrodine" in control of urge urinary incontinence in women.
2) Method : Randomized clinical trial.
3) The study population: Major inclusion criteria: 18-80 old women with urge or mixed with urge dominance urinary incontinence who referred to pelvic floor clinic in Imam Khomeini Hospital of Tehran. Other inclusion criteria: Been symptomatic from at least 3 months ago; not have been treated for at least 2 week before study; Who are health mentally and physically.
Exclusion criteria: Positive urine culture; Uncontrolled diabetic; Uncontrolled HTN; History of glaucoma; History of drug allergy; Neuralgic disease; Bladder cancer; Hematuria; Residual volume more than 110 in sonography; Any voiding dysfunction in history. 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 72 subjects. Interventions: "Toltrodine" is given to control group and herbal medicine syrup consist of "Myrtus Communis" is given to case group. Duration of intervention: 4 weeks. Major out come variations: Reduction in symptoms severity after treatment upon ICIQ-SF questionnaire that is validated in Persian.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014102819734N1
Registration date:2015-01-13, 1393/10/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-01-13, 1393/10/23
Registrant information
Name
Fatemeh Nojavan
Name of organization / entity
Iran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 3316 8839
Email address
nojavan.f@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Iran University of Medical Sciences
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2014-11-21, 1393/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison Between Traditional Iranian Medicine Product Consist of "Myrtus Communis" with "Toltrodine" in Control of Urge Urinary Incontinence in Women
Public title
Efficacy of Traditional Iranian Medicine Product in Control of Urinary Incontinence in Women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Female with urge incontinence or mixed incontinence with urge dominance; Who have been symptomatic from at least 3 months ago; Not have been treated for at least 2 week; and are health mentally.
Exclusion criteria: Positive urine culture; Uncontrolled diabetic; Uncontrolled HTN; History of glaucoma; History of drug allergy; Neuralgic disease; Bladder cancer; Hematuria; Residual volume more than 110 in sonography; Any voiding dysfunction in history
Age
From 18 years old to 80 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Science
Street address
501, 5th Floor, Central Building of Tehran University of Medical Sciences, Keshavarz and Qods Junction, Tehran, Iran
City
Tehran
Postal code
Approval date
2013-08-21, 1392/05/30
Ethics committee reference number
92/5/130/1058
Health conditions studied
1
Description of health condition studied
urge urinary incontinence
ICD-10 code
N39.4
ICD-10 code description
Other specified urinary incontinence
Primary outcomes
1
Description
Reduction of the symptoms severity
Timepoint
Before and 4 weeks after treatment
Method of measurement
ICIQ-SF questionnaire
Secondary outcomes
1
Description
advers effect of drug
Timepoint
any time after starting drug
Method of measurement
asking from patients
Intervention groups
1
Description
Intervention group: Traditional Herbal Syrup which is a aqueous extract of "Myrtus Communis" leaves.
Dosage: 15 cc 20-40 min after each meal means 45 cc per day.
Category
Treatment - Drugs
2
Description
Control group: Tab 2 mg "Toltrodine" 2 times a day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Pelvic Floor Clinic of Imam Khomeini Hospital belongs to Tehran University of Medical Science
Full name of responsible person
Fatemeh Nojavan
Street address
End of Keshavarz Blv, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Iran University of Medical Sciences
Full name of responsible person
Dr Morteza Naserbakht
Street address
Hemmat Hwy, Tehran, Iran
City
Tehran
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, Iran 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
Research Institute for Islamic and Complementary Medicine
Full name of responsible person
Fatemeh Nojavan
Position
Ph.D Student of Traditional Iranian Medicine
Other areas of specialty/work
Street address
No. 9, Pirnia alley, Lalezar Now Ave., Jomhouri Eslami St., Tehran
City
Tehran
Postal code
1145847111
Phone
+98 21 3316 8839
Fax
+98 21 3311 6726
Email
nojavan.f@tak.iums.ac.ir
Web page address
http://ricm.iums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Zinat Ghanbari
Position
Specialist of Obstetric and Gynecology
Other areas of specialty/work
Street address
End of Keshavarz Blv, Imam Khomeini Hospital, Pelvic Floor Clinic,Tehran, Iran
City
Tehran
Postal code
1419733141
Phone
+98 21 6643 8633
Fax
+98 21 6643 8633
Email
drz_ghanbari@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Research Institute for Islamic and Complementary Medicine
Full name of responsible person
Fatemeh Nojavan
Position
Ph.D Student of Traditional Iranian Medicine
Other areas of specialty/work
Street address
No. 9, Pirnia alley, Lalezar Now Ave., Jomhouri Eslami St
City
Tehran
Postal code
1145847111
Phone
+98 21 3326 8839
Fax
+98 21 3311 6726
Email
mapfn2001@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)