Prophylactic effect of Kegel physical exercises and physiotherapy versus no intervention on the urinary incontinency and urinary urgency after normal delivery: a randomized clinical trial
To assess the effect of prophylactic effect of Kegel physical exercises and physiotherapy versus no intervention on the urinary incontinence and urinary urgency after normal delivery
Design
This is a randomized clinical trial, phase II, in which 150 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible women with normal delivery who will refer to Fatemieh Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the drawing of lots.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 35 years,
Normal and term delivery,
Singleton
Exclusion criteria:
Episiotomy,
Gestational diabetes,
Preeclampsia
Intervention groups
Intervention group 1: Routine postpartum care plus Kegel physical exercise 3 times a day every week for 6 weeks including pelvic floor contraction for 10 seconds and will be repeated for 15 to 20 times in supine, standing, and quadruped position
Intervention group 2: Routine postpartum care plus physiotherapy of the pelvic floor muscle once a week for 6 weeks
Control group:
Just routine postpartum care
Main outcome variables
Primary outcome:
Urinary incontinence and urinary urgency
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N326
Registration date:2019-12-27, 1398/10/06
Registration timing:registered_while_recruiting
Last update:2019-12-27, 1398/10/06
Update count:0
Registration date
2019-12-27, 1398/10/06
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Prophylactic effect of Kegel physical exercises and physiotherapy versus no intervention on the urinary incontinency and urinary urgency after normal delivery: a randomized clinical trial
Public title
Prophylactic effect of Kegel physical exercises and physiotherapy versus no intervention on the urinary incontinence and urinary urgency after normal delivery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 35 years,
Normal and term delivery,
Singleton
Exclusion criteria:
Episiotomy,
Gestational diabetes,
Preeclampsia
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare three sheets and write "intervention 1" on one sheet and "intervention 2" on the other sheet and "control" on the third one. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group.
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2019-11-16, 1398/08/25
Ethics committee reference number
IR.UMSHA.REC.1398.646
Health conditions studied
1
Description of health condition studied
Urinary incontinence
ICD-10 code
N39.3
ICD-10 code description
Stress incontinence (female) (male)
2
Description of health condition studied
Urinary urgency
ICD-10 code
R39.15
ICD-10 code description
Urgency of urination
Primary outcomes
1
Description
Urinary incontinence and urinary urgency
Timepoint
6 weeks after the intervention
Method of measurement
By taking history
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Routine postpartum care plus Kegel physical exercise 3 times a day every week for 6 weeks including pelvic floor contraction for 10 seconds and will be repeated for 15 to 20 times in supine, standing, and quadruped position
Category
Prevention
2
Description
Intervention group 2: Routine postpartum care plus physiotherapy of the pelvic floor muscle once a week for 6 weeks
Category
Prevention
3
Description
Control group: Just routine postpartum care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital in Hamadan city
Full name of responsible person
Dr Mahsa Bakhtiar
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
mahsabakhthari629189@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr Mahsa Bakhtiar
Position
Resident of Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
mahsabakhthari629189@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Mahsa Bakhtiar
Position
Resident of Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
mahsabakhthari629189@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available