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IRCT20221208056749N1 IRCT 2023-05-23 Esfahan University of Medical Sciences Investigating the effect of platelet rich plasma (PRP) injection in women with stress urinary incontinence Investigating the effect of platelet-rich plasma (PRP) injection in Kelly plication in women with stress urinary incontinence 2023-06-05 anticipated 60 Complete https://irct.ir/trial/67312 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method is permuted block randomization. In this way, first using online software (sealedenvelope), a sequence of random numbers will be created and by the same software, the generated numbers will be divided into 6 blocks of 10. Which is an equal number in each block will be 5 items from the intervention group and 5 items from the control group. So by doing each block, 5 patients (equally) will be assigned to each group, Blinding description: Considering that patients do not know how to perform the Kelley pillification method and are unconscious during the intervention. Therefore, one of the groups was only treated with this method and for the second group, in addition to this method, PRP injection will be used. 3 Stress urinary incontinence. Intervention 1: Intervention group: Before surgery, blood samples of patients are taken and sent to the laboratory to prepare PRP. To prepare PRP, a volume of 12 cc was taken from peripheral blood of the patient, mixed with sodium citrate, centrifuged for 10 minutes at 1200 rpm, and the obtained plasma is rich in platelets. After the Kelley pillication surgery and in the operating room, immediately before the injection, 0.5 cc of calcium chloride solution is mixed to degranulate the platelets and injected in the proximal areas of the duct at 3, 6, and 9 o'clock. Intervention 2: Control group: Patients of this group will be treated by the Kelley pillification method. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Dr. Maryam Haj Hashemi
Felezi bridge, Shahid Beheshti Hospital
Esfahan Iran (Islamic Republic of) 8184853542 +98 31 3236 7005 Hajhashemy73@yahoo.com Esfahan University of Medical Sciences scientific Dr. Maryam Haj Hashemi
Shahid Beheshti Hospital, Felezi Bridge
Esfahan Iran (Islamic Republic of) 8184853542 +98 31 3236 7005 Hajhashemy73@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Women over 20 years Moderate to mild stress urinary incontinence Diagnosing stress urinary incontinence based on history, physical examination and questionnaire Failure to respond to medical treatments for stress urinary incontinence Written informed consent to participate in the present study 20 years no limit Female Existence of detrusor hyperactivity in urodynamics History of stress urinary incontinence surgery Urinary tract infection Obesity (BMI greater than 30) N39.49 Other specified urinary incontinence Treatment - Surgery Treatment - Surgery Intervention group: Before surgery, blood samples of patients are taken and sent to the laboratory to prepare PRP. To prepare PRP, a volume of 12 cc was taken from peripheral blood of the patient, mixed with sodium citrate, centrifuged for 10 minutes at 1200 rpm, and the obtained plasma is rich in platelets. After the Kelley pillication surgery and in the operating room, immediately before the injection, 0.5 cc of calcium chloride solution is mixed to degranulate the platelets and injected in the proximal areas of the duct at 3, 6, and 9 o'clock Control group: Patients of this group will be treated by the Kelley pillification method Pain. Timepoint: One month, 3 months, 6 months and 12 months after surgery. Method of measurement: Visual Analogue Scale. Amount of urine leakage. Timepoint: One month, 3 months, 6 months and 12 months after surgery. Method of measurement: Urinary distress inventory (UDI-6). Frequency of urinary leakage. Timepoint: One month, 3 months, 6 months and 12 months after surgery. Method of measurement: Incontinence Questionnaire–Urinary Incontinence Short Form (ICIQ-UI SF). Esfahan University of Medical Sciences Approved 2022-09-06 Ethical Committee of Isfahan University of Medical Sciences Isfahan, Azadi Square, Isfahan University of Medical Sciences Esfahan Isfehan Iran (Islamic Republic of)