The purpose of the present study is to evaluate the effect of Kegel excersise with and without Kegelmaster devise on the urinary incontinence in women.
Materials & method:
A randomized clinical trial was performed on 91 women with the complaint of urinary incontinence who had the inclusion criteria. They were randomly assigned into the two groups. In the case group (n=41), after complete training, kegel master devise were used twice daily and 15 minutes every session, for a total duration of 12 weeks. The control group (n= 50), after complete training, kegel exercises were done ( including perineal muscles contractions for 6-8 seconds with 6 seconds rest in between), twice daily and 15 minutes every session, for a total duration of 12 weeks. Then these two groups were compared according to the scores of special questionnaires, before , 1 and 3 months after interventions.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138811252624N3
Registration date:2010-05-03, 1389/02/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-05-03, 1389/02/13
Registrant information
Name
Maryam Kashanian
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7752 3487
Email address
maryamka@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences, Deputy of Research and Technology
Expected recruitment start date
2009-01-01, 1387/10/12
Expected recruitment end date
2009-12-01, 1388/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Kegel excersise and Kegelmaster devise on the urinary incontinence in women and a comparison between them
Public title
Effect of Kegel excersise and Kegelmaster devise on the urinary incontinence
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: stress urinary incontinence (SUI) and mixed urinary incontinence, reproductive age (before menopause) and normal urinalysis and negative urine culture.
Exclusion criteria: pregnancy or post partum period (6 weeks after delivery), any drug use or surgery for UI, any urogenital infection, any systemic disorders or drug use, including chronic degenerative disorders, neuromuscular disorders, rapid progressive pelvic prolapsus, cardiac pacemaker, and other forms of UI.
Age
From 25 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
38
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
Iran University of Medical Sciences
Street address
Iran University of Medical Sciences
City
Tehran
Postal code
Approval date
2009-03-01, 1387/12/11
Ethics committee reference number
1182874
Health conditions studied
1
Description of health condition studied
urinary incontinence in women
ICD-10 code
N39.3
ICD-10 code description
Stress incontinence
2
Description of health condition studied
Other specified urinary incontinence
ICD-10 code
N39.4
ICD-10 code description
Other specified urinary incontinence
Primary outcomes
1
Description
quality of life
Timepoint
1 and 3 months after interventions
Method of measurement
questionnaires
2
Description
strength of pelvic floor muscles
Timepoint
1 and 3 months after interventions
Method of measurement
Oxford grading system
3
Description
capability to participate in the social activities
Timepoint
1 and 3 months after interventions
Method of measurement
Questionnaire
4
Description
number of involuntary urine passage
Timepoint
1 and 3 months after interventions
Method of measurement
questionnaire
5
Description
severity of urinary incontinence
Timepoint
1 and 3 months after interventions
Method of measurement
Visual Analogue Scoring (VAS),
Secondary outcomes
empty
Intervention groups
1
Description
Kegelmaster devise
Category
Treatment - Devices
2
Description
Kegel exercises
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbarabadi Teaching Hospital
Full name of responsible person
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
12 Bahban Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences, Deputy of Research and Technology
Full name of responsible person
Dr Motavallian
Street address
Iran University of Medical Sciences, Deputy of Research and Tech
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences, Deputy of Research and Technology
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
Iran University of Medical Sciences
Full name of responsible person
Dr. Maryam Kashanian
Position
MD, Associate professor
Other areas of specialty/work
Street address
No 9, Mostaghimi Alley, Khajeh Nasir Toosi Avenue.
City
Tehran
Postal code
16117
Phone
+98 21 7752 3487
Fax
Email
maryamkashanian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.Maryam Kashanian
Position
MD, Associate professor
Other areas of specialty/work
Street address
No 9, Mostaghimi Alley, Khajeh Nasir Toosi Avenue, post code 16117, Tehran. Iran.
City
Tehran
Postal code
16117
Phone
+98 982177523487
Fax
Email
maryamkashanian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.Maryam Kashanian
Position
MD,Associate professor
Other areas of specialty/work
Street address
No 9, Mostaghimi Alley, Khajeh Nasir Toosi Avenue.
City
Tehran
Postal code
16117
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)