Effect of transurethral plasma rich platelet combined with autologous fat injection versus autologous fat injection on abdominal leak point pressure in patient with stress urinary incontinence: a double blinded randomized clinical trial
Objectives: To assess the effect of transurethral plasma rich platelet combined with autologous fat injection versus autologous fat injection on abdominal leak point pressure in patient with stress urinary incontinence.
Design: a double blinded randomized clinical trial.
Setting and conduct: All eligible patients 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) patients with stress urinary incontinence; (b) abdominal leak point pressure less than 100 cm of water.
Exclusion criteria: (a) hyperactivity of the detrusor muscle; (b) contraindication of anesthesia; (c) presence of anatomical disorder in bladder; (d) platelet disorder.
Intervention: Transurethral injection of 25 ml plasma rich platelet combined with 25 ml autologous fat single dose.
Control: Transurethral injection of 25 ml autologous fat single dose.
Primary outcome: evaluation of improvement of urinary incontinence before intervention and every 3 months after intervention for 18 months by history taking.
Secondary outcome: (a) evaluation of urinary retention one week after intervention by history taking; (b) thromboembolism 48 hours after intervention by physical examination; (c) urinary infection one week after intervention by history taking.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201410219014N44
Registration date:2014-10-27, 1393/08/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-10-27, 1393/08/05
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
2012-09-22, 1391/07/01
Expected recruitment end date
2014-09-21, 1393/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of transurethral plasma rich platelet combined with autologous fat injection versus autologous fat injection on abdominal leak point pressure in patient with stress urinary incontinence: a double blinded randomized clinical trial
Public title
Effect of transurethral plasma rich platelet combined with autologous fat injection versus autologous fat injection on abdominal leak point pressure in patient with stress urinary incontinence
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a) patients with stress urinary incontinence; (b) abdominal leak point pressure less than 100 cm of water.
Exclusion criteria: (a) hyperactivity of the detrusor muscle; (b) contraindication of anesthesia; (c) presence of anatomical disorder in bladder; (d) platelet disorder.
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: 46 envelopes will be prepared including 23 envelopes having plasma rich platelet combined with autologous fat and 23 envelope having autologous fat. Then, each envelope will be given randomly to every patient.
Blinding: Neither the patients nor the physician who will exam the patients will aware of the type of intervention. Therefore, the study will be run as double blinded.
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 Hamadan
City
Hamadan
Postal code
6517838695
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
P/16/35/9/2886
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
evaluation of improvement of urinary incontinence
Timepoint
before intervention and every 3 months after intervention for 18 months
Method of measurement
by history taking
Secondary outcomes
1
Description
evaluation of urinary retention
Timepoint
one week after intervention
Method of measurement
by history taking
2
Description
thromboembolism
Timepoint
48 hours after intervention
Method of measurement
by physical examination
3
Description
urinary infection
Timepoint
one week after intervention
Method of measurement
by history taking
Intervention groups
1
Description
Transurethral injection of 25 ml plasma rich platelet combined with 25 ml autologous fat single dose.
Category
Treatment - Drugs
2
Description
Transurethral injection of 25 ml autologous fat single dose.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Dr Masood Jafari
Street address
Shahid Beheshti Hospital, Eram Bul.
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 Masood Jafari
Position
Resident of Urology
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Eram Bul.
City
Hamadan
Postal code
Phone
+98 81 3838 0717
Fax
Email
m.jafari2442 @gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti Hospital
Full name of responsible person
Dr Ali Amirzargar
Position
Urologist
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Eram Bul.
City
Hamadan
Postal code
Phone
+98 81 3838 0717
Fax
Email
dr-amirzargar@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)