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IRCT20140911019125N7 IRCT 2020-05-02 Kerman University of Medical Sciences Treatment of stress urinary incontinence in women Evaluation of autologous muscle derived stem cells and fibroblasts injection into the women’s paraurethral tissues for the treatment of stress urinary incontinence. 2017-02-19 anticipated 25 Complete https://irct.ir/trial/47345 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 Stress Urinary Incontinences in women. 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.. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no additional data.
public Alireza Farsinejad
Paramedical college, Kerman University of Medical Sciences, Haft Bagh blvd
Kerman Iran (Islamic Republic of) 7616911333 +98 34 3132 5374 afarsinejad@kmu.ac.ir Kerman University of Medical Sciences scientific Alireza Farsinejad
Paramedical college, Kerman University of Medical Sciences, Haft Bagh blvd
Kerman Iran (Islamic Republic of) 7616911333 +98 34 3132 5374 afarsinejad@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) 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 40 years 65 years Female 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 N39.3 Stress incontinence (female) (male) Treatment - Drugs 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. Closure pressure. Timepoint: Before intervention and 1,3,6,12 months after intervention. Method of measurement: Urodynamic test. Urinary flow rate. Timepoint: Before intervention and 1,3,6 and 12 months after intervention. Method of measurement: Urodynamic test. Maximum detrusor pressure during voiding. Timepoint: Before intervention and 1,3,6,12 months after intervention. Method of measurement: Urodynamic test. Amount of urine left. Timepoint: Before intervention and 1,3,6,12 months after intervention. Method of measurement: Urodynamic test. Severity of urinary symptoms. Timepoint: Before intervention and 1,3,6,12 months after intervention. Method of measurement: questionnaire. Kerman University of Medical Sciences Approved 2017-01-22 Ethics committee of Kerman University of Medical Sciences Kerman University of Medical Sciences, Haft Bagh blvd Kerman Kerman Iran (Islamic Republic of)