efficacy of Saussurea costus (Qost) oil, Iranian Traditional Medicine product, on female urinary incontinence; double blinded randomized clinical trial
Objectives: evaluating the efficacy of Saussurea costus oil, an Iranian traditional medicine product, on signs and symptoms and quality of life of female urinary incontinence according to International Consultation on Incontinence Questionnaire -Urinary Incontinence Short Form (ICIQ-SF) and Incontinence Quality of Life (I-QOL) questionnaires compared to placebo
Design, Setting and conduct: double blinded (Information on the type of drug and the patient in a sealed envelope is presented to a third party so that both the patient and the researchers are unaware of the type of oil).In this randomized clinical trial, randomized blocking method has been done. 30-70 old women with stress or mixed urinary incontinence are allocated into placebo and intervention groups. Each group having 40 subjects.It is two center (pelvic floor clinic in Imam Khomeini Hospital of Tehran University of Medical Sciences and Traditional medicine center in Ardabil).
Inclusion criteria: 30-70 old women with stress or mixed urinary incontinence who have been symptomatic for at least 3 months
Exclusion criteria: acute or recurrent urine infection
Interventions: Intervention group will receive Saussurea Costus oil while the other group receives placebo oil. Drug used in both groups is Local application twice a day applied to area between the navel and pubic region. Results will be evaluated on weeks 3 and 6 and one month after the end of intervention. Evaluation of possible skin side effects will be done on weeks 3 and 6 of the study.
Major outcome variations: evaluating symptoms severity and quality of life after treatment using ICIQ-SF and I-QOL questionnaires that validated in Persian
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015110924970N1
Registration date:2016-01-15, 1394/10/25
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-01-15, 1394/10/25
Registrant information
Name
Zahra Niktabe
Name of organization / entity
Tehran University of Medical Sciences, Tradirional Medicine Faculty
Country
Iran (Islamic Republic of)
Phone
+98 21 2298 8550
Email address
z-niktabe@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research, Tehran University of Medical Sciences, University School of Traditional Medicine
Expected recruitment start date
2016-03-10, 1394/12/20
Expected recruitment end date
2016-09-19, 1395/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
efficacy of Saussurea costus (Qost) oil, Iranian Traditional Medicine product, on female urinary incontinence; double blinded randomized clinical trial
Public title
efficacy of Saussurea costus (Qost) oil on female urinary incontinence
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 30-70 old women with stress or mixed urinary incontinence; Being symptomatic for at least 3 months; not been treated for at least 2 week before study; Who are willing to participate in research and Have signed a consent form; After explaining the research objectives of the study and informed consent, patients will be enrolled. Exclusion criteria: acute or recurrent urinary tract infection; pregnancy or lack of contraception; allergy to oily drug products; chronic degenerative neuromuscular disease; Bladder cancer or previous record of it; pain of bladder or painful urine voiding; disease or drugs that were be effective on our research results such as diuretics; record of pelvic surgery during past one year; drug misuse during study; Unwillingness to continue participation in the study; drug side effects during study
Age
From 30 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization is performed using randomized blocks.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
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
2015-11-07, 1394/08/16
Ethics committee reference number
IR.TUMS.REC.1394.1113
Health conditions studied
1
Description of health condition studied
Stress urinary incontinence
ICD-10 code
N39.3
ICD-10 code description
Stress incontinence
2
Description of health condition studied
Mixed urinary incontinence
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
Frequency of urinary leakage
Timepoint
At the beginning of the intervention, after 3 and 6 weeks, 1 month after end of intervention
Method of measurement
International Consultation on Incontinence Questionnaire -Urinary Incontinence Short Form (ICIQ-SF) questionnaire
2
Description
The amount of urine leakage
Timepoint
At the beginning of the intervention, after 3 and 6 weeks, 1 month after end of intervention
Method of measurement
International Consultation on Incontinence Questionnaire -Urinary Incontinence Short Form (ICIQ-SF) questionnaire
3
Description
Time leakage: leakage befor sleep
Timepoint
At the beginning of the intervention, after 3 and 6 weeks, 1 month after end of intervention
Method of measurement
International Consultation on Incontinence Questionnaire -Urinary Incontinence Short Form (ICIQ-SF) questionnaire
4
Description
Time of leakage: leakage before reaching the bathroom
Timepoint
At the beginning of the intervention, after 3 and 6 weeks, 1 month after end of intervention
Method of measurement
International Consultation on Incontinence Questionnaire -Urinary Incontinence Short Form (ICIQ-SF) questionnaire
5
Description
Time leakage: leakage of urine with coughing and sneezing
Timepoint
At the beginning of the intervention, after 3 and 6 weeks, 1 month after end of intervention
Method of measurement
International Consultation on Incontinence Questionnaire -Urinary Incontinence Short Form (ICIQ-SF) questionnaire
6
Description
The leakage of urine: leakage of urine with exercise
Timepoint
At the beginning of the intervention, after 3 and 6 weeks, 1 month after end of intervention
Method of measurement
International Consultation on Incontinence Questionnaire -Urinary Incontinence Short Form (ICIQ-SF) questionnaire
7
Description
The leakage of urine: urine leakage after urination immediately prior to wearing underwear
Timepoint
At the beginning of the intervention, after 3 and 6 weeks, 1 month after end of intervention
Method of measurement
International Consultation on Incontinence Questionnaire -Urinary Incontinence Short Form (ICIQ-SF) questionnaire
8
Description
Assessment of changes in quality of life
Timepoint
At the beginning of the intervention, after 3 and 6 weeks, 1 month after end of intervention
Method of measurement
Incontinence Quality of Life (I-QOL) questionnaire
Secondary outcomes
1
Description
presumptive skin complications
Timepoint
3 weeks after research start and 6 weeks after that (end of intervention)
Method of measurement
Measurement form of drug complications According to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Intervention groups
1
Description
Intervention group: Saussurea costus oil; local use; frequency of use of the drug twice a day; Area of oil application is navel to pubic area; Each time the oil volume is 2/3 ml; Intervention time is 6 weeks
Category
Treatment - Drugs
2
Description
control group: placebo oil; local use; local use; Frequency of use of the drug twice a day; Area of oil application is navel to pubic area; Each time the volume of oil is 2/3 ml; Intervention time is 6 weeks
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 Sciences
Full name of responsible person
Zahra Niktabe
Street address
Keshavarz Blvd, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research, School of Traditional medicine, Tehran University of Medical Sciences
Full name of responsible person
Roja Rahimi
Street address
School of Traditional medicine, Tehran University of Medical Sciences, Giti Alley, Vafamanesh Street, Heravi Square, Pasdaran Street, 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, School of Traditional medicine, Tehran 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
School of Traditional Medicine, Tehran University of Medical Sciences, Iran
Full name of responsible person
Zahra Niktabe
Position
PhD candidate of Traditional Medicine
Other areas of specialty/work
Street address
School of Traditional Medicine, Tehran University of Medical Sciences, Giti Alley, Vafamanesh Street, Heravi Square, Pasdaran Street, Iran
City
Tehran
Postal code
Phone
+98 21 2298 8565
Fax
Email
z-niktabe@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Traditional Medicine, Tehran University of Medical Sciences, Giti Alley, Vafamanesh Street
Full name of responsible person
Malieheh Tabarraie Arani
Position
PhD of Traditional Medicine
Other areas of specialty/work
Street address
School of Traditional Medicine, Tehran University of Medical Sciences, Giti Alley, Vafamanesh Street, Heravi Square, Pasdaran Street, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2298 8565
Fax
Email
dr.mtabarraie@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Traditional Medicine, Tehran University of Medical Sciences, Iran
Full name of responsible person
Zahra Niktabe
Position
PhD candidate of Traditional Medicine
Other areas of specialty/work
Street address
School of Traditional Medicine, Tehran University of Medical Sciences, Giti Alley, Vafamanesh Street, Heravi Square, Pasdaran Street, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2298 8565
Fax
Email
z-niktabe@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)