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IRCT20230508058117N1 IRCT 2023-11-20 Tehran University of Medical Sciences Evaluation of the clinical consequences of botulonium toxin a compared to medical treatment in patients with urge incontinence Evaluation of the clinical consequences of botulonium toxin a compared to medical treatment in patients with urge incontinence 2023-11-22 anticipated 60 Complete https://irct.ir/trial/73589 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, all eligible patients were assigned to three groups using random sequence extraction from the computer (via www.randomization.com) and simple randomization. The resulting random numbers, i.e. the allocation of patients to groups, was concealed using sealed envelopes, Blinding description: Neither the patients nor the researcher know the type of intervention. 2-3 urge incontinence. Intervention 1: The first group: receive routine treatment of 200 units of botulinum toxin. Intervention 2: Group 2: They receive routine treatment with a single injection of 300 units of Botox into the bladder muscle (intra detrusor). Intervention 3: Group 3: treated with antimuscarinic drugs (solifenacin 5 mg orally daily for 6 months). Yes - There is a plan to make this available What will be shared: All individual data of the participants in this study will be shared after unidentifiable individuals When: The access period will start from 2022to 2023 To whom: Data will be available to researchers working in the university. Conditions: Just for performing research Where to obtain: Refer to the responsible person for accessing the data How to obtain: The data will be available one month after the responsible person's approval Comments:
public Fatemeh Hosseini Selaki Seri
Tehran, District 6, Pour Sina St
Tehran Iran (Islamic Republic of) 1461884513 +98 21 6119 0000 hosseini.m.f.11@gmail.com Tehran University of Medical Sciences scientific Fatemeh Hosseini Selaki Seri
Tehran, District 6, Pour Sina St
Tehran Iran (Islamic Republic of) 1461884513 +98 21 6119 0000 hosseini.m.f.11@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Accurate diagnosis of patients with urge incontinence based on the diagnosis of a pelvic floor specialist, women over the age of 18, suffering from urge incontinence and in the case of a history of non-response to antimuscarinic drugs in the past 3 months; Urgent incontinence and having a history of antimuscarinic drug complications (constipation, blurred vision, dry mouth) 18 years no limit Female Patients with urinary tract infection, interstitial cystitis, having an intermittent or permanent catheter previous pelvic radiotherapy treatment neurogenic urge incontinence a history of sensitivity to Botox; Use of aminoglycoside drugs contraindications for receiving antimuscarinic treatment (tachyrhythmia, angle-closure glaucoma) N39.41 Urge incontinence Treatment - Drugs Treatment - Drugs Treatment - Drugs The first group: receive routine treatment of 200 units of botulinum toxin. Group 2: They receive routine treatment with a single injection of 300 units of Botox into the bladder muscle (intra detrusor). Group 3: treated with antimuscarinic drugs (solifenacin 5 mg orally daily for 6 months) ICIQ-OAB questionnaire score. Timepoint: Before treatment, one week, 1 month after treatment. Method of measurement: Patient's answer. Tehran University of Medical Sciences Approved 2023-06-20 Ethics committee of tehran University of Medical Sciences Tehran, District 6, Pour Sina St Tehran Tehran Iran (Islamic Republic of)