Investigating the effect of magnetic therapy on the improvement of stress urinary incontinency in obese women referred to Ghadir mother and child hospital
The Effect of Magnet Therapy on Improving Stress Urinary Incontinence in Obese Women
Design
A randomized, controlled, single blinded clinical trial
Settings and conduct
In this clinical trial study, 22 obese women with stress urinary incontinence were randomly divided into two groups.11 in control group and 11 in intervention group. patients do only special exercises in control group and patients also received magnet therapy in other group. Both of groups evaluated at the beginning of study, at the end of 8th session and one month after last session. A person out of study evaluated patients in blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women over 21 years with similar number of deliveries with stress urinary incontinence. Body mass index in the range of 30-35 .Lack of neurological diseases .Lack of sensory and motor disorders. No mental illness No muscular and articular disease .Urinary leakage during cough .Urinary incontinence and quality of life questionnaire score of at leas tudy voluntarily and by signing the consent form.
Exclusion criteria: other types of urinary incontinence such as urgent urinary incontinence .History of any heart failure .Pacemaker and metal in body. Acute infection. Malignancy 6 Pregnancy or pregnancy attempts. Surgery to treat stress urinary incontinence. Vaginal bleeding. History of pelvic surgery between 3-8 weeks ago. History of pelvic radiation. ulcers or burns in the pelvic area. History of medication for urinary incontinence in the last three months. High blood sugar above 100mmol / lit 14.
Intervention groups
Group 1: Magnet therapy and pelvic floor exercises. Group 2: Pelvic floor exercises only.
Main outcome variables
The quality of life questionnaire related to urinary incontinence, the number of pads used and the amount of urine leakage
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190909044734N2
Registration date:2020-03-21, 1399/01/02
Registration timing:retrospective
Last update:2020-03-21, 1399/01/02
Update count:0
Registration date
2020-03-21, 1399/01/02
Registrant information
Name
Leila Abbasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 1551
Email address
leabbasi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2020-07-21, 1399/04/31
Actual recruitment start date
2019-04-21, 1398/02/01
Actual recruitment end date
2019-07-22, 1398/04/31
Trial completion date
2019-10-22, 1398/07/30
Scientific title
Investigating the effect of magnetic therapy on the improvement of stress urinary incontinency in obese women referred to Ghadir mother and child hospital
Public title
The effect of magnet therapy on the improvement of urinary incontinence
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women 21 years and older
with similar number of deliveries
with stress urinary incontinence
Body mass index in the range of 30-35
Lack of neurological diseases such as multiple sclerosis.
Lack of sensory and motor disorders.
Lack of mental illnesses (preventing proper communication and understanding)
no musculoskeletal disorders.
presence of urine leakage during coughing
urine leakage of about 200-250 ml.
incontinence questionnaire score Urine and quality of life should be at least 6 (normal is 21).
Ability to perform pad test
The patient should participate in the study voluntarily and by signing the consent form.
Exclusion criteria:
People with other types of urinary incontinence such as urgent urinary incontinence, functional urinary incontinence, mixed urinary incontinence.
History of any heart failure and illness such as severe cardiac arrhythmia
hypertension.
Pacemaker and metal In the body
Acute infection
Malignancy
Pregnancy or try for pregnancy
Surgery to treat stress urinary incontinence.
Vaginal bleeding
History of pelvic surgery between 3-8 weeks ago
History of pelvic radiation
Having Pelvic ulcer or burn.
History of medication for urinary incontinence in the past three months such as alpha-adrenergic, diuretic, serotonin, epinephrine.
High blood sugar glucose 100mmol / lit
Age
From 21 years old
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
24
Actual sample size reached:
22
Randomization (investigator's opinion)
Randomized
Randomization description
Volunteer patients were randomly assigned to one of two intervention or control groups with blocked randomization method. six blocks with the size of four were considered and 12 subjects were placed in each group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients were aware of the second group at the time of filling out the informed consent form and were therefore not blind to the groups. The therapists were also aware of both groups and types of treatment, and the just the person who evaluate the patients was completely blind to the groups and treatment received, and the data were also analyzed by someone who was completely blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of research of Shiraz Faculty of Rehabilitation Sciences
Street address
Abyvardi 1 Street. Chamran Blvd.
City
shiraz
Province
Fars
Postal code
1733-71345
Approval date
2019-04-17, 1398/01/28
Ethics committee reference number
IR.SUMS.REHAB.REC.1398.002
Health conditions studied
1
Description of health condition studied
Pelvic floor disorder
ICD-10 code
N39.3
ICD-10 code description
Stress incontinence (female) (male)
Primary outcomes
1
Description
The quality of life questionnaire,
Timepoint
Before the intervention and treatment of the eighth session and one month after the last treatment session
Method of measurement
I-QOL questionnaire
2
Description
urinary incontinence intensity,
Timepoint
Before the intervention and treatment of the eighth session and one month after the last treatment session
Method of measurement
By determining the amount of urine absorbed in the pad
3
Description
urinary incontinence frequency,
Timepoint
Before the intervention and treatment of the eighth session and one month after the last treatment session
Method of measurement
Using the patient self report
4
Description
urine frequency,
Timepoint
Before the intervention and treatment of the eighth session and one month after the last treatment session
Method of measurement
Using the patient self report
5
Description
delivery frequency,
Timepoint
Before the intervention and treatment of the eighth session and one month after the last treatment session
Method of measurement
Using the patient self report
6
Description
BMI
Timepoint
Before the intervention and treatment of the eighth session and one month after the last treatment session
Method of measurement
using BMI index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: They received magnet therapy and pelvic floor exercises
Category
Rehabilitation
2
Description
Control group:They only received pelvic floor exercises
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz School of Rehabilitation
Full name of responsible person
Leila Abbasi
Street address
Abiverdi 1 street, Chamran Blvd
City
Shiraz
Province
Fars
Postal code
1733-71345
Phone
+98 71 3627 1551
Fax
+98 71 3627 2495
Email
leabbasi@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Younes Ghasemi
Street address
Zand Street, opposite Palestine Street,Central Building of Shiraz University of Medical Sciences, research vice-chancellor