Evaluation of autologous muscle derived stem cells and fibroblasts injection into the women’s paraurethral tissues for the treatment of stress urinary incontinence.
Study the effect of autologous muscle derived stem cells and fibroblasts injection into the women’s paraurethral tissues for the treatment of stress urinary incontinence
Design
Clinical trial without control group, community based, not blinded, non-randomized study
Settings and conduct
This study is conducted in the field of urology. Its location is Bahonar Hospital and the Comprehensive Center for Stem Cells and Reconstructive Medicine of Kerman University of Medical Sciences. After the patient is selected by the physician, the stem cells are injected into the bladder sphincter in one session. Results are checked 1,3, 6 and 12 months after injection.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Women aged between 40 to 65 years old; Stress Urinary Incontinence symptoms; Urodynamic stress incontinence confirmed by multichannel urodynamic testing;
Positive cough stress test;
desire to surgical correction of stress urinary incontinence; inadequate response to conservative treatment of SUI.
Exclusion criteria:
History of surgery on external genitalia, bladder neck, bladder or urethra;
Desire to future childbearing;
History of bleeding or current anti-coagulation therapy;
Current genitourinary fistula or urethral diverticulum
Intervention groups
In this study there will be one group in which stem cells are injected into patients once and followed up after 1,3,6 and 12 months after injection.
Main outcome variables
Closure pressure, Urinary flow rate, Maximum detrusor pressure during voiding, Amount of urine left, severity of urinary symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140911019125N7
Registration date:2020-05-02, 1399/02/13
Registration timing:retrospective
Last update:2020-05-02, 1399/02/13
Update count:0
Registration date
2020-05-02, 1399/02/13
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 32 24618
Email address
afarsinejad@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of autologous muscle derived stem cells and fibroblasts injection into the women’s paraurethral tissues for the treatment of stress urinary incontinence.
Public title
Treatment of stress urinary incontinence in women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged between 40 to 65 years old
Stress Urinary Incontinence symptoms
Urodynamic stress incontinence confirmed by multichannel urodynamic testing
Positive cough stress test
Patients desire to surgical correction of stress urinary incontinence
inadequate response to conservative treatment of SUI
Exclusion criteria:
History of surgery on external genitalia, bladder neck, bladder or urethra
Desire to future childbearing
History of bleeding or current anti-coagulation therapy
Current genitourinary fistula or urethral diverticulum
Active urinary infection
Uncontrolled Diabetes
Age
From 40 years old to 65 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
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 University of Medical Sciences, Haft Bagh blvd
City
Kerman
Province
Kerman
Postal code
7616911333
Approval date
2017-01-22, 1395/11/03
Ethics committee reference number
IR.KMU.REC.1395.349
Health conditions studied
1
Description of health condition studied
Stress Urinary Incontinences in women
ICD-10 code
N39.3
ICD-10 code description
Stress incontinence (female) (male)
Primary outcomes
1
Description
Closure pressure
Timepoint
Before intervention and 1,3,6,12 months after intervention
Method of measurement
Urodynamic test
2
Description
Urinary flow rate
Timepoint
Before intervention and 1,3,6 and 12 months after intervention
Method of measurement
Urodynamic test
3
Description
Maximum detrusor pressure during voiding
Timepoint
Before intervention and 1,3,6,12 months after intervention
Method of measurement
Urodynamic test
4
Description
Amount of urine left
Timepoint
Before intervention and 1,3,6,12 months after intervention
Method of measurement
Urodynamic test
5
Description
Severity of urinary symptoms
Timepoint
Before intervention and 1,3,6,12 months after intervention
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The sample taken from the patient is brought to the laboratory. The sample is then digested enzymatically and cultured. After the cells reach a sufficient confluency, 40 million cells are injected into the bladder sphincter.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bahonar Hospital
Full name of responsible person
Azar Danesh Pajooh
Street address
Bahonar Hospital; Gharani street
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
azdaneshpajooh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhty
Street address
Kerman University of Medical Sciences, Haft Bagh blvd
City
Kerman
Province
Kerman
Postal code
7616911333
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
Kerman University of Medical Sciences
Full name of responsible person
Alireza Farsinejad
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Hematology
Street address
Paramedical college, Kerman University of Medical Sciences, Haft Bagh blvd
City
Kerman
Province
Kerman
Postal code
7616911333
Phone
+98 34 3132 5374
Email
afarsinejad@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Alireza Farsinejad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Hematology
Street address
Paramedical college, Kerman University of Medical Sciences, Haft Bagh blvd
City
Kerman
Province
Kerman
Postal code
7616911333
Phone
+98 34 3132 5374
Email
afarsinejad@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Alireza Farsinejad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Hematology
Street address
Paramedical college, Kerman University of Medical Sciences, Haft Bagh blvd
City
Kerman
Province
Kerman
Postal code
7616911333
Phone
+98 34 3132 5374
Email
afarsinejad@kmu.ac.ir
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
There is no additional data.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
In our study non of the personal data of patients will be shared. Only data that are related to outcomes of intervention will be shared.
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
The data will be available for people working in academic institutions and clinicians.
Under which criteria data/document could be used
Applicants are only allowed to use received data in clinical and they are not allowed to published them
From where data/document is obtainable
1- Phone: 034-31325374 2- e-mail: afarsinejad@kmu.ac.ir 3- Fax: 034-31325375 4- address: Dr. Alireza Farsinejad; Kerman University of Medical science; Haft Bagh blvd
What processes are involved for a request to access data/document
Applicant can receive information after contact and send e-mail up to 10 days.