Comparison of the incidence of urinary incontinence in two methods of transobturator and mini sling surgery and urodynamic markers in patients with urinary incontinence
Comparison of the incidence of urinary incontinence in two methods of transobturator and mini sling surgery and urodynamic markers in patients with urinary incontinence
Design
randomized clinical trial
Randomization with computerized program for random allocation and sealed envelopes:at the time of open envelope surgery and the type of operation was determined.
To estimate the sample size, studies will be used from similar studies that similar groups have been compared. Considering the results of the comparison in the change of hospital stay and the duration of surgery in a similar study, this study was conducted using the comparative formulas of the meanings considering alpha = 0.5 and beta = 0.2 and the probability of the loss of study samples in each A group of 35 people is considered. .
Settings and conduct
In this RCT study in Shahid Hasheminejad Hospital, women who are referred to Urology Clinic with complaints of stress urinary incontinence included in the study.
Participants/Inclusion and exclusion criteria
Women with urinary incontinence were studied
EXCLUSION CRITERIA:
overactive bladder
under medical treatment
high post void residue
neurological deficit
pelvic inflammatory disease
pelvic organ prolapse
recurrence of prior surgery
Intervention groups
women with stress urinary incontinence
They were divided into mini-sling and transobturator groups
The transobturator group was designated as a control according to a further history of usage
Main outcome variables
urodynamic study
FSFI questionnaire(female sexual function index)
ICIQ questionnaire(International Consultation on Incontinence Questionnaire )
pain questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180407039216N1
Registration date:2018-04-22, 1397/02/02
Registration timing:registered_while_recruiting
Last update:2018-04-22, 1397/02/02
Update count:0
Registration date
2018-04-22, 1397/02/02
Registrant information
Name
Abdolreza Momtazan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4489 3413
Email address
momtazan.ar@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
2018-04-21, 1397/02/01
Actual recruitment end date
2018-06-22, 1397/04/01
Trial completion date
empty
Scientific title
Comparison of the incidence of urinary incontinence in two methods of transobturator and mini sling surgery and urodynamic markers in patients with urinary incontinence
Public title
anti incontinence surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
stress urinary incontinence
female
Exclusion criteria:
non stress urinary incontinence
POP
high PVR
neurological deficit
PID
recurrence of prior surgery
under medical treatment
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
random allocation Individuals were randomly assigned to a TOT or mini sling technique using a random sequence in a 1: 1 ratio design and were randomly assigned to a series of sealed envelopes.
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 Iran University of Medical Science
Street address
Valinezhad Ave., Valie Asr Ave.,
City
Tehran
Province
Tehran
Postal code
1969714713
Approval date
2018-03-04, 1396/12/13
Ethics committee reference number
IR.IUMS.FMD.REC 1396.9311254002
Health conditions studied
1
Description of health condition studied
female urinary incontinence
ICD-10 code
N39.3
ICD-10 code description
Stress incontinence (female) (male)
Primary outcomes
1
Description
Changes in urodynamic quantities
Timepoint
before and after surgery
Method of measurement
urodynamic study , female sexual function questionaire (FSFI questionaire) ,International Consultation on Incontinence Questionnaire( ICIQ questionaire)
Secondary outcomes
1
Description
Change in sexual activity score
Timepoint
before and 8 week after surgery
Method of measurement
FSFI questionaire(female sexual function index)
Intervention groups
1
Description
Intervention group: mini sling anti incontinence surgery
Category
Treatment - Surgery
2
Description
Control group: transobturator anti incontinence surgery
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Hasheminezhad Kidney center
Full name of responsible person
Abdolreza Momtazan
Street address
Valinezhad Ave., Valie Asr Ave.
City
Tehran
Province
Tehran
Postal code
1969714713
Phone
+98 21 8864 4427
Email
Rmomtazan@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Kazem Malakouti
Street address
Hemmat highway,next to milad tower ,Iran University of medicine
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
malakouti.k@iums.ac.ir
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
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
Iran University of Medical Sciences
Full name of responsible person
Abdolreza Momtazan
Position
urology rezident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Valinezhad Ave.
City
Tehran
Province
Tehran
Postal code
1969714713
Phone
+98 21 8864 4427
Email
Rmomtazan@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Abdolreza Momtazan
Position
urology rezident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Valinezhad Ave.
City
Tehran
Province
Tehran
Postal code
1969714713
Phone
+98 91288644427
Email
Rmomtazan@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Abdolreza Momtazan
Position
urology rezident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Valinezhad Ave.
City
Tehran
Province
Tehran
Postal code
1969714713
Phone
+98 21 8864 4427
Email
Rmomtazan@gmail.com
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