Effect of simultaneous injection of autologous fat with platelet-rich plasma on the fat thickness of the bladder neck and proximal urethra in women with stress urinary incontinence: a before after clinical trial
Objectives: To assess the effect of simultaneous injection of autologous fat with PRP on the fat thickness of the bladder neck and proximal urethra.
Design: a before and after clinical trial.
Setting and conduct: Eligible women with stress urinary incontinence who will refer to the Shahid Beheshti Hospital during the study period will be enrolled in to the trial.
Inclusion criteria: (a) having stress urinary incontinence; (b) female sex; (c) age of 20 to 80 years.
Exclusion criteria: (a) presence of moderate to severe cystocele; (b) detrusor overactivity in urodynamic test; (c) history of ureteral surgery; (d) hypermobility of the ureter (more than 30 degrees); (e) obesity (BMI more than 30)
Intervention: injection of 1 ml subcutaneous fat at the proximal of urethra at 3, 6, and 9 o'clock positions seven times plus injection of 0.5 ml platelet-rich plasma at the proximal of urethra at 3, 6, and 9 o'clock positions seven times.
Control: comparison with the patients' condition before intervention.
Primary outcome: Assessing the fat thickness of the bladder neck and proximal urethra in mm using MRI before intervention and one week and 3 months later.
Secondary outcome: Assessing the urethra bleeding one week after intervention with question form the patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201409299014N41
Registration date:2014-10-07, 1393/07/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-10-07, 1393/07/15
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2013-01-20, 1391/11/01
Expected recruitment end date
2014-01-21, 1392/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of simultaneous injection of autologous fat with platelet-rich plasma on the fat thickness of the bladder neck and proximal urethra in women with stress urinary incontinence: a before after clinical trial
Public title
Effect of simultaneous injection of autologous fat with platelet-rich plasma on the fat thickness of the bladder neck and proximal urethra in women with stress urinary incontinence
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a) having stress urinary incontinence; (b) female sex; (c) age of 20 to 80 years.
Exclusion criteria: (a) presence of moderate to severe cystocele; (b) detrusor overactivity in urodynamic test; (c) history of ureteral surgery; (d) hypermobility of the ureter (more than 30 degrees); (e) obesity (BMI more than 30)
Age
From 20 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
23
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
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2014-03-02, 1392/12/11
Ethics committee reference number
D/P/16/35/9/4200
Health conditions studied
1
Description of health condition studied
stress urinary incontinence
ICD-10 code
N39.3
ICD-10 code description
Stress incontinence
Primary outcomes
1
Description
Assessing the fat thickness of the bladder neck and proximal urethra in mm
Timepoint
before intervention and one week and 3 months later
Method of measurement
using MRI
Secondary outcomes
1
Description
Assessing the urethra bleeding
Timepoint
one week after intervention
Method of measurement
with question form the patients
Intervention groups
1
Description
injection of 1 ml subcutaneous fat at the proximal of urethra at 3, 6, and 9 o'clock positions seven times plus injection of 0.5 ml platelet-rich plasma at the proximal of urethra at 3, 6, and 9 o'clock positions seven times
Category
Treatment - Drugs
2
Description
comparison with the patients' condition before intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Dr Adel Eslami
Street address
Shahid Beheshti Hospital, Eram Ave
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti Hospital
Full name of responsible person
Dr Adel Eslami
Position
Resident of Urology
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0705
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti Hospital
Full name of responsible person
Dr Mohammad Ali Amirzargar
Position
Urologist
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0705
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)