The effect of acupuncture stimulation on hip and bladder pelvic floor muscle in women with urinary incontinence in the age range of 40-75 years and its effects on urine volume
Investigating the role of electroacupuncture in the improvement of patients with non-stress incontinence
Design
This study is a randomized clinical trial. Patients with confirmed urinary incontinence are examined. The samples are randomly divided into two groups of intervention and control. By reviewing the literature and according to the studies carried out taking into account the ability of 80% and A significant 5% and Effect size of 7% and a drop of 10% of the sample jig are determined in each group of 38. The intervention will be performed using sterile acupuncture needles of 30x75, as well as an electroacupuncture device. The control group will also receive sham acupuncyure in addition to pelvic floor exercises by sticking the needles in the mercuric points on the skin, and other components The intervention will be similar to the intervention group.
Settings and conduct
This study is a randomized clinical trial conducted between Sina Hospital and the Urology Center of Sina Hospital.
Participants/Inclusion and exclusion criteria
1-patients with confirmed stress-incontinence are included in the study
2-patients with non-stress incontinence are excluded from the study
3-Women with cardiovascular disease, pelvic orthopedic palsy, sensory neural disorders, pelvic neoplasms or pelvic diseases, bleeding ulcers, and anticoagulant drugs are not expected to be included in the study.
Intervention groups
The intervention will be performed using sterile needles of acupuncture size of 30 to 75, as well as an electroacupuncture device.
Main outcome variables
Time for urinating insomnia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131218015841N3
Registration date:2018-07-31, 1397/05/09
Registration timing:prospective
Last update:2018-07-31, 1397/05/09
Update count:0
Registration date
2018-07-31, 1397/05/09
Registrant information
Name
Gholamreza Pourmand
Name of organization / entity
Urology Research Center,Tehran University of Medical Sciences,Tehran,Iran
Country
Iran (Islamic Republic of)
Phone
+98 21 6634 8560
Email address
pourmand@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-06, 1397/05/15
Expected recruitment end date
2019-08-06, 1398/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of acupuncture stimulation on hip and bladder pelvic floor muscle in women with urinary incontinence in the age range of 40-75 years and its effects on urine volume
Public title
Evaluation of electroacupuncture in patients with stress urinary incontinency.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patiens with confirmed stress-incontinence are inclluded in the study
Exclusion criteria:
patiens with non-stress incontinence are excluded from the study
Age
From 40 years old to 75 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
More than 1 sample in each individual
Number of samples in each individual:
18
3 times a week for 6 months
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice-Chancellor in research affairs-Tehran University of Medical Sciences
Street address
Quds Street
City
Tehran
Province
Tehran
Postal code
1136746911
Approval date
2018-06-20, 1397/03/30
Ethics committee reference number
IR.TUMS.VCR.REC.1397.179
Health conditions studied
1
Description of health condition studied
NON-stress incontinence
ICD-10 code
N99-N99
ICD-10 code description
Other disorders of the genitourinary system
Primary outcomes
1
Description
Pad test
Timepoint
Before and after 6 weeks
Method of measurement
Scales with accurate to 0.001
2
Description
Check the amount of urine tract
Timepoint
First and after 6 weeks
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Using sterile acupuncture needles in size of 30 to 75, as well as an electroacupuncture device. The needles will be inserted in the double-sided BL33 points (at the third pierced sacral) at a 30 to 45 degree angle and BL35 at a distance of 10 mm from the end of the coccyx, and some in the posterolateral path. After the needles are drawn, some will be manipulated until the person feels de qi (sense of needle, limb, limb, or other senses). The electrodes of the device are then attached to the needles and the electrical waves will be fed at 50 Hz and amplified from 1 to 5 ampoleides for 30 minutes. This intervention will take 3 sessions a week for 6 weeks. The intervention group, in addition to the electro-echo pumpkin, will perform three sessions per week on separate days with pelvic floor booster exercises with 3 sets of 10 repetitions of Kegel exercise on separate days from the eco-pumpkin.
Category
Treatment - Other
2
Description
Control group: In addition to pelvic floor exercise, Sham acupuncyure will be received by sticking the needles in the mercurial points on the skin, and other intervention components will be similar to the intervention group.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital, Urology Research Center
Full name of responsible person
Dr.Maryam Abolhasani
Street address
Hassan-abad Sq.Emam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8561
Fax
+98 21 6634 8560
Email
dr_m_abolhasani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
dr.mohammadali Sahraian
Street address
Tehran, Keshavarz Blvd,Quds Street,Central Building of Tehran University of Medical Sciences, Sixth Floor
City
Tehran
Province
Tehran
Postal code
1124344674
Phone
+98 21 8163 3627
Email
www.sahraian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr.Maryam Abolhasani
Position
faculty memberE
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Hanan Abad Sq,Emam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Email
dr_m_abolhasani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Gholamreza Pourmand
Position
faculty member
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Hasan Abad Sq,Emam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Email
gh_pourmand@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farzaneh bagherpour
Position
Associate
Latest degree
Bachelor
Other areas of specialty/work
Laboratory Medicine
Street address
Hasan Abad Sq,Emam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Email
farzaneh.bagherpoor@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
-
When the data will become available and for how long
-
To whom data/document is available
-
Under which criteria data/document could be used
-
From where data/document is obtainable
-
What processes are involved for a request to access data/document