Evaluation and comparison of the effectiveness of two methods of tension free surgical intervertebral medial autologous sling and synthetic vaginal sling in the correction of stress urinary incontinence
Evaluation and comparison of the effectiveness of two methods of tension free surgical intervertebral medial autologous sling( modified sling ) and synthetic vaginal sling in the correction of stress urinary incontinence
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, on 48 patients. Balanced blocks were used for randomization.
Settings and conduct
Hashminejad and Moheb Mehr hospital. Two blind strains
Participants/Inclusion and exclusion criteria
Existence of urinary stress incontinence in history and iciq questionnaire and its confirmation by urodynamic evaluation and cough test
Intervention groups
Patients in 2 groups: sling surgery with artificial mesh (TVT, control group) and sling surgery with autologous rectus fascia modified compared to the classical method (intervention group, in the classical method, a fascia incision with a length and width of approximately 1.5 x 9 cm is used and this autologous tissue is placed in the neck of the bladder. In the modified method of this process, a shorter tissue of about 1.5 x 5 cm is used and placed in the mid-urethral in the group of intervention patients). And the aim is to investigate the effectiveness and success of the treatment in two methods
Main outcome variables
Investigating the effectiveness and success of the sling method with artificial mesh. The expectation is: 1- equal efficacy 2- reduction of financial burden - removal of artificial mesh cost 3- reduction of voiding dysfunction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211123053163N1
Registration date:2023-04-29, 1402/02/09
Registration timing:retrospective
Last update:2023-04-29, 1402/02/09
Update count:0
Registration date
2023-04-29, 1402/02/09
Registrant information
Name
gohar haghpanah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 81161
Email address
haghpanahgohar@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-21, 1401/01/01
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
2022-04-28, 1401/02/08
Actual recruitment end date
2023-01-05, 1401/10/15
Trial completion date
2023-01-05, 1401/10/15
Scientific title
Evaluation and comparison of the effectiveness of two methods of tension free surgical intervertebral medial autologous sling and synthetic vaginal sling in the correction of stress urinary incontinence
Public title
Evaluation and comparison of the effectiveness of two methods of tension free surgical intervertebral medial autologous sling and synthetic vaginal sling in the correction of stress urinary incontinence
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
stress urinary incontinence
Exclusion criteria:
Urinary tract infection during surgery
Suspicion of urogenital malignancy
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
48
Actual sample size reached:
48
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting the samples using the randomization method with balanced blocks, people are divided into two intervention and comparison groups, and using this table, the surgical method of each patient is determined and a special code is considered for each patient.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this process, after selecting the patients for surgical treatment and choosing the type of operation of the patient by means of balanced blocks (48 patients, 8 envelopes of 6 in fact, the envelopes contain 6 F or T labels, the F labels indicate sling surgery with Fascia and T label indicate TVT sling action). After selecting the patient completely randomly from inside the envelopes, a label is given to the patient as the type of random surgery and this label is also considered as the patient code in addition to showing the type of surgery of the patient. With this method, the patient does not have a role in consciously choosing the type of operation.
On the other hand, after collecting the data of each patient, this data is provided to the analyzer with the relevant code, and in fact, the analyzer is not aware of the type of operation of the patient, and all the data is analyzed randomly and coded. .
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committees of School of Medicine
Street address
Vali nezahd St
City
Tehran
Province
Tehran
Postal code
1969714713
Approval date
2022-04-24, 1401/02/04
Ethics committee reference number
IR.IUMS.FMD.REC.1401.057
Health conditions studied
1
Description of health condition studied
Urinary stress incontinence
ICD-10 code
N39.3
ICD-10 code description
Stress incontinence (female) (male)
Primary outcomes
1
Description
The level of patient satisfaction in urinary control
Timepoint
3 consecutive months after surgery
Method of measurement
Examination with a cough test and the number of pads used daily
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: People who undergo modified sling surgery
Category
Treatment - Surgery
2
Description
Intervention group 2: This group includes 24 people and the patient's autologous tissue is used instead of artificial mesh.
Category
Treatment - Surgery
3
Description
Control group 1: This group consisted of 24 people and classical synthetic vaginal sling surgery was performed on these people. Placement of artificial mesh in mid-urethral
Category
Treatment - Surgery
4
Description
Intervention group 3: The desired autologous tissue from the rectus fascia is used with a shorter size than the classic method and the placement of this tissue is in the mid-urethral, which in the classic method, this tissue is placed in the neck of the bladder.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Hashemi nezhad Kidney center
Full name of responsible person
Dr Emami
Street address
Vali nezhad St
City
Tehran
Province
Tehran
Postal code
1969714713
Phone
+98 21 8864 4424
Email
support@hkc.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Bagheri
Street address
Vali nezhad st
City
Tehran
Province
Tehran
Postal code
1969714713
Phone
+98 21 8864 4424
Email
support@hkc.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Dr Emami
Position
Doctor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Vali nezhad
City
Tehran
Province
Tehran
Postal code
1969714713
Phone
+98 21 8864 2444
Email
support@hkc.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Emami
Position
Doctor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Vali nezhad
City
Tehran
Province
Tehran
Postal code
1969714713
Phone
+98 21 8864 2444
Email
support@hkc.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Haghpanah
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Vali St
City
Tehran
Province
Tehran
Postal code
1434894733
Phone
+98 911 372 6685
Email
support@hkc.ir
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
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
Title and more details about the data/document
I have not decided yet
When the data will become available and for how long
I have not decided yet
To whom data/document is available
I have not decided yet
Under which criteria data/document could be used
I have not decided yet
From where data/document is obtainable
I have not decided yet
What processes are involved for a request to access data/document