Determination of the effect of paraurethral injection of platelet rich plasma on the treatment of stress urinary incontinence in women who coming to kerman besat clinic in 2017
Design
Pilot Randomized control trial with 2 parallel groups .not blinded
Settings and conduct
Patients referring to Besat Clinic of Kerman are divided to the intervention and control groups، according to the random numbers table after having the inclusion criteria . A total of 20 patients were studied. 10 patients were selected as control and 10 patients were randomly selected for experimental groups. In the urology unit of Shahid Bahonar Hospital of Kerman University of Medical Sciences, according to the criteria of the study,patients in the control group received standard treatment Mid Urethral Sling and in the intervention group, patients are candidates for paraurethral PRP injections.
Participants/Inclusion and exclusion criteria
The study population consisted of patients aged 30-65 years with stress urinary incontinence (SUI) who referred to the Kerman Bessat Clinic in 1396, which did not respond to conservative, medication and pelvic floor exercises, and according to the inclusion criteria they candidate for paraurethral Platelet rich plasma (PRP ) injection
Intervention groups
10 patients in the intervention group were candidates for paraurethral injection of PRP and 10 patient in the control group received standard treatment of SUI (midurethral sling surgury).
Main outcome variables
State of Severity of stress urinary incontinence
State of quality of life in stress urinary incontinence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171201037697N1
Registration date:2019-01-04, 1397/10/14
Registration timing:retrospective
Last update:2019-01-04, 1397/10/14
Update count:0
Registration date
2019-01-04, 1397/10/14
Registrant information
Name
atefe eslami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 4452 0136
Email address
atefe_eslami70@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-04, 1396/01/15
Expected recruitment end date
2018-03-19, 1396/12/28
Actual recruitment start date
2017-04-04, 1396/01/15
Actual recruitment end date
2017-08-22, 1396/05/31
Trial completion date
2017-10-17, 1396/07/25
Scientific title
Study on the effect of paraurethral injection of platelet rich plasma on the treatment of stress urinary incontinence in women
Public title
Study on the effect of PRP on the treatment of urinary incontinenece
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female
Existence of Stress urinary incontinence(SUI) symptom
Confirm of SUI based on urodinamic test
Positive cough stress test
Age 30 - 65 Yr
No reply to conversative treeatment or intrested in surgical treatment for SUI
Exclusion criteria:
post void residual (PVR) more than 100cc
evidence of Detrusor overactivity in urodynamic test before surgery
Positive history for midurethral sling surgery or any surgery on external genitalia ,bladder, bladder neck or urethra
Genitourinary system infection
Genitourinary system malignancy
Positive history of bleeding disorders or recent anticoagulant treatment
Positive recent history of Genitourinary fistula or urethral diverticulum
Positive recent history of cyctocele or rectocele
Uncontrolled diabetes mellitus
Any contraindication for surgery
Age
From 30 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Actual sample size reached:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Based on random number table
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 kerman university of medical sciences
Street address
Kerman.haft bagh alavi AVe.paradis of kerman university of medical sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2017-09-25, 1396/07/03
Ethics committee reference number
IR.KMU.REC.1396.1270
Health conditions studied
1
Description of health condition studied
stress urinary incontinence
ICD-10 code
N39.3
ICD-10 code description
Stress incontinence (female) (male)
Primary outcomes
1
Description
The Severity of urinary incontinence
Timepoint
0,1,3 month ofter intervention
Method of measurement
International Consultation on Incontinence Questionnaire(ICIQ) , The Questionnaire for Urinary Incontinence Diagnosis(QUID ) , clinical examination( cough stress test)
2
Description
Quality of Life
Timepoint
0,1,3 month ofter intervention
Method of measurement
The Incontinence Quality of Life questionnaire(I-QOL)
Secondary outcomes
empty
Intervention groups
1
Description
intervention group:blood sampling was done.20ml of intravenous blood was taken on anticoagulant (ACD) and centrifuged in15ml Falcon tubes for 10 minutes at 800 RPM, and after separation and transfer of platelet-rich plasma"Which was deposited on RBCs", was added to 15ml new falcons and re-centrifuged for 15 minutes at 3500 RPM, after removing of upper part of plasma , concentrated platelet was obtained. About 3ml of this concentrate was taken with an insulin syringe and then in the operating room under general anesthesia with cyctourethroscopy and special needles injected at two points of the rabdosphingter(in the middle of the urethra) by the urologist. and then Platelet-rich-plasma was injected at two points with lower depth in the submucosa separately for supportive effect .This method did not require hospitalization after intervention.
Category
Treatment - Surgery
2
Description
Control group: after receiving satisfaction and performing routine preoperative tests, in the operating room and under general anesthesia, patients were treated with midurethral sling surgury by the urologist (standard treatment of urinary stress incontinence). they were admitted and monitored for 24-24 hours after surgery
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat clinic of kerman
Full name of responsible person
Dr.azar daneshpajooh
Street address
Besat clinic of kerman.,jahad blvd
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
Azdaneshpajooh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr.abbas pardakhti
Street address
pardis of kerman university of medical sciences ., Haft bagh alavi blvd
City
Kerman
Province
Kerman
Postal code
:13555-76169
Phone
+98 34 3226 3855
Email
abpardakhty@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Shiraz University of Medical Sciences
Full name of responsible person
Atefe eslami
Position
General practitioner
Latest degree
Medical doctor
Other areas of specialty/work
Family Physician
Street address
Eghlid .shhrmian village.mahdieh clinic
City
Eghlid
Province
Fars
Postal code
7381689611
Phone
+98 71 4452 0136
Email
Atefe_eslami70@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr.azar daneshpajooh
Position
assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Kerman.shahid gharani Ave
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 32235011
Email
Azdaneshpajooh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Atefe eslami
Position
General practitioner
Latest degree
Medical doctor
Other areas of specialty/work
Family Physician
Street address
mahdieh clinic . Shahrmian village
City
Eghlid
Province
Fars
Postal code
۷۳۸۱۶۸۹۶۱۱
Phone
+98 71 4453 5136
Email
Atefe_eslami70@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data can be shared after unidentifiable people
When the data will become available and for how long
Start the access period from 1398
To whom data/document is available
Accessible for researcher in academic institutions
Under which criteria data/document could be used
Email and obtain permission from the original researcher (Dr. Azar Daneshahi Pajooh)
From where data/document is obtainable
Dr.azar daneshpajooh
What processes are involved for a request to access data/document
After sending the email to the researcher of the project, applicants will be given a maximum of 1 month