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IRCT20211123053163N1 IRCT 2023-04-29 Iran University of Medical Sciences Evaluation and comparison of the effectiveness of two methods of tension free surgical intervertebral medial autologous sling and synthetic vaginal sling in the correction of stress urinary incontinence Evaluation and comparison of the effectiveness of two methods of tension free surgical intervertebral medial autologous sling and synthetic vaginal sling in the correction of stress urinary incontinence 2022-03-21 anticipated 48 Complete https://irct.ir/trial/69667 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After selecting the samples using the randomization method with balanced blocks, people are divided into two intervention and comparison groups, and using this table, the surgical method of each patient is determined and a special code is considered for each patient, Blinding description: In this process, after selecting the patients for surgical treatment and choosing the type of operation of the patient by means of balanced blocks (48 patients, 8 envelopes of 6 in fact, the envelopes contain 6 F or T labels, the F labels indicate sling surgery with Fascia and T label indicate TVT sling action). After selecting the patient completely randomly from inside the envelopes, a label is given to the patient as the type of random surgery and this label is also considered as the patient code in addition to showing the type of surgery of the patient. With this method, the patient does not have a role in consciously choosing the type of operation. On the other hand, after collecting the data of each patient, this data is provided to the analyzer with the relevant code, and in fact, the analyzer is not aware of the type of operation of the patient, and all the data is analyzed randomly and coded. . N/A Urinary stress incontinence. Intervention 1: Intervention group 1: People who undergo modified sling surgery. Intervention 2: Intervention group 2: This group includes 24 people and the patient's autologous tissue is used instead of artificial mesh. Intervention 3: Control group 1: This group consisted of 24 people and classical synthetic vaginal sling surgery was performed on these people. Placement of artificial mesh in mid-urethral. Intervention 4: Intervention group 3: The desired autologous tissue from the rectus fascia is used with a shorter size than the classic method and the placement of this tissue is in the mid-urethral, ​​which in the classic method, this tissue is placed in the neck of the bladder. Yes - There is a plan to make this available What will be shared: I have not decided yet When: I have not decided yet To whom: I have not decided yet Conditions: I have not decided yet Where to obtain: I have not decided yet How to obtain: I have not decided yet Comments:
public Dr Emami
Vali nezhad
Tehran Iran (Islamic Republic of) 1969714713 +98 21 8864 2444 support@hkc.ir Iran University of Medical Sciences scientific Dr Emami
Vali nezhad
Tehran Iran (Islamic Republic of) 1969714713 +98 21 8864 2444 support@hkc.ir Iran University of Medical Sciences Iran (Islamic Republic of) stress urinary incontinence no limit no limit Female Urinary tract infection during surgery Suspicion of urogenital malignancy N39.3 Stress incontinence (female) (male) Treatment - Surgery Treatment - Surgery Treatment - Surgery Treatment - Surgery Intervention group 1: People who undergo modified sling surgery Intervention group 2: This group includes 24 people and the patient's autologous tissue is used instead of artificial mesh. Control group 1: This group consisted of 24 people and classical synthetic vaginal sling surgery was performed on these people. Placement of artificial mesh in mid-urethral Intervention group 3: The desired autologous tissue from the rectus fascia is used with a shorter size than the classic method and the placement of this tissue is in the mid-urethral, ​​which in the classic method, this tissue is placed in the neck of the bladder. The level of patient satisfaction in urinary control. Timepoint: 3 consecutive months after surgery. Method of measurement: Examination with a cough test and the number of pads used daily. Iran University of Medical Sciences Approved 2022-04-24 Ethics Committees of School of Medicine Vali nezahd St Tehran Tehran Iran (Islamic Republic of)