Clinical trial of comparison of medium-term results of single incision mini-sling and stem cell therapy in the treatment of women’s stress urinary incontinence
30 patients referred to the urology clinic of Kerman University of Medical Sciences were randomly selected and randomly divided into two groups under mini-sling surgery and stem cell injection.The study is double blind, the patient and the outcome assessor are unaware of the type of treatment performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Women at the age of 18 years old and over;
history of SUI;
Failure to respond to conservative managements after 3 months;
Urine leak in the initial examination during coughing or Valsalva maneuver ;
Non-inclusion criteria:
persistent urinary tract infection (UTI);
proved VUR;
History of previous SUI surgery;
history of Bulking agent injection in urethra;
history of neurological diseases such as MS, CVA, or muscular dystrophy;
Obesity (BMI> 40);
Localized fibrosis and stiffness at the injection site in the cystoscopy.
Intervention groups
Intervention group 1"Surgery group": 15 patients underwent mini-sling surgery
Intervention Group 2 "Injection Group": 15 patients were first performed mucosal sampling and then stem cell preparation and underwent stem cell injection.
Main outcome variables
Stress urinary incontinence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190517043609N2
Registration date:2020-05-03, 1399/02/14
Registration timing:retrospective
Last update:2020-05-03, 1399/02/14
Update count:0
Registration date
2020-05-03, 1399/02/14
Registrant information
Name
mohammadali bagherinasabsarab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3222 1600
Email address
ma_bagherinasab_md@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-10-10, 1395/07/19
Expected recruitment end date
2018-10-10, 1397/07/18
Actual recruitment start date
2016-10-10, 1395/07/19
Actual recruitment end date
2018-03-10, 1396/12/19
Trial completion date
2018-06-01, 1397/03/11
Scientific title
Clinical trial of comparison of medium-term results of single incision mini-sling and stem cell therapy in the treatment of women’s stress urinary incontinence
Public title
Comparison of surgery and stem cell therapy in the treatment of women’s urinary incontinence
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women at least 18 years old
history of SUI (Stress Urinary Incontinence)
Failure to respond to conservative managements after 3 months
Urine leak in the initial examination during coughing or Valsalva maneuver
Exclusion criteria:
persistent urinary tract infection (UTI)
proved Vesicouretral Reflux (VUR)
History of previous Stress urinary incontinence surgery
history of neurological diseases such as Cerebro Vascular Accident(CVA) ,muscular dystrophy or Multiple Sclerosis(MS)
Obesity (Body Mass Index(BMI)> 40)
Localized fibrosis and stiffness at the injection site in the cystoscopy
high grade cystocele and rectocele (equal to or more than 3 according to the pelvic organ prolapse quantification system (POP-Q)
Overactive bladder symptoms (Uninhibited contractions, low capacity, low compliance in urodynamic study)
Medium to severe bladder trabeculation and or open bladder neck in cystourethroscopy
Residue of urine > 100cc and or maximum flow rates of lower than 15 ml/s
Pregnant or intending future pregnancies
coagulation disorders
history of Bulking agent injection in urethra
Age
From 18 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, block randomization method is used by using blocks of size 6, in each block consisting 3 part is for surgical intervention group and 3 is for injection intervention group, with the aim that the groups progress in a balanced way over time and
This method continues until the sample size reaches 30 people (including 15 intervention groups and 15 control groups or 5 blocks of 6)
Blinding (investigator's opinion)
Single blinded
Blinding description
The study is single blind and the patient do not know the type of treatment (surgery or injection) performed but the primary researcher (physician and data collector) knows the type of treatment
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 University of Medical Sciences; Emam Khomeini blvd
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2016-08-25, 1395/06/04
Ethics committee reference number
IR.KMU.REC.1395.343
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
Examination of stress urinary
Timepoint
1, 3, 6 and 12 months after the intervention ( surgery or stem cell injection)
Method of measurement
International Urinary Incontinence Questionnaire(IIQ score)
Secondary outcomes
empty
Intervention groups
1
Description
intervention group: In the stem cell injection group: After obtaining written consent, the mucosal tissue sample is separated from the volunteer patients by the physician and placed in a phosphate buffer solution containing antibiotics and amphotericin and sent immediately to the university stem cell center. The cells collected for injection into the patient are given to the physician as a suspension. After obtaining the required amount of stem cells (6 10 10 64), the sample is sent to the urology operating room as freez, and after melting with normal saline, it is 0.9% diluted (up to 4 cc) and with a cystoscope in two areas in the sphincter. The external urine is injected (8 injections 0.5 cc). After three months, the injection is given again.
Category
Treatment - Surgery
2
Description
Intervention group2: In the other group, for mini-sling surgery with mesh insertion, after venous sedation and lithotomy position with a 1 cm mid-urethral incision, a short arm mesh of Boston company is inserted.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Urology Clinic of Bahonar Hospital in Kerman
Full name of responsible person
Mahbobe Mirzaie
Street address
Bahonar hospital.Qareney St,Kerman
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
mirzaeimahboubeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhti
Street address
Kerman University of Medical Sciences; Emam Khomeini blvd
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
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
Mahbube Mirzaie
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Kerman University of Medical Science,Emam khomeini Blv,Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
mirzaeimahboubeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mahbube Mirzaie
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Kerman University of Medical Science;Emam Khomeini Blv,Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
mirzaeimahboubeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mohammadali Bagherinasab
Position
Urology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Kerman University of Medical Sciences; Emam Khomeini blvd
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
ma_bagherinasab_md@yahoo.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