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IRCT20190618043934N25 IRCT 2024-05-13 Mashhad University of Medical Sciences Posterior tibial nerve stimulation and anticholinergic drug solifenacin in patients with overactive bladder Comparison of the therapeutic effects of posterior tibial nerve stimulation and the anticholinergic drug sulifenacin in patients with hyperactive bladder 2024-04-20 anticipated 118 Complete https://irct.ir/trial/76242 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Placement of patients in two intervention and control groups by simple random block method into two groups where each person in one of the intervention group (A): treated with stimulation of the posterior tibial nerve or control and group (B): patients treated with anti-inflammatory drugs Cholinergic visol solifenacin will be placed. First, blocks of four were created as AABB, ABAB, BABA, BBAA, ABBA, BAAB. Blocks are placed in sealed envelopes. Then one of these envelopes is randomly removed for the first patient and the placement of the next 3 patients in each of the following groups is determined. Then randomization is done for other patients as well, Blinding description: Outcome evaluator: The study manager (4th year urology assistant) will evaluate and analyze the data without knowing the placement of the patients in the study groups. 3 Overactive bladder. Intervention 1: Intervention group: The first intervention group: for 12 weeks, 2 sessions per week and each session for 30 minutes under posterior tibial nerve stimulation treatment and before and after the intervention (3 months after the start of the intervention) the considered parameters are evaluated. Intervention 2: Control group: Group second intervention: The patients are treated with the anticholinergic drug Visol solifenacin manufactured by Abidi company with a dose of 5 mg once a day for 12 weeks. Before and after the intervention (3 months after the intervention), the considered parameters are evaluated. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no need to publish individual patient information
public Zabihullah Mohaghegh
School of Medicine, Birjand University of medical sciences, Ghahhari Blvd, Birjand Town
Birjand Iran (Islamic Republic of) 9717934888 +98 56 3232 3232 oabstudent@gmail.com Birjand University of Medical Sciences scientific Dr Zhila Sheikhi
School of Medicine-Ghaem Hospital-Mashhad University of Medical Science-Mashhd_Iran
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3232 3232 sheikhizh@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Having informed consent to enter the study Passing urine more than 8 times in 24 hours At least 6 months have passed since the onset of symptoms Creating an emergency to urinate, which is accompanied by urgency urinary incontinence no limit no limit Both Refusal to continue the plan pregnancy having a history of surgery to treat urinary incontinence treatment with anticholinergic drugs having a urinary tract infection N32.81 Overactive bladder Treatment - Other Treatment - Drugs Intervention group: The first intervention group: for 12 weeks, 2 sessions per week and each session for 30 minutes under posterior tibial nerve stimulation treatment and before and after the intervention (3 months after the start of the intervention) the considered parameters are evaluated. Control group: Group second intervention: The patients are treated with the anticholinergic drug Visol solifenacin manufactured by Abidi company with a dose of 5 mg once a day for 12 weeks. Before and after the intervention (3 months after the intervention), the considered parameters are evaluated. Quality of Life. Timepoint: At the beginning of the study and 3 months after the start of the intervention. Method of measurement: Using a questionnaire to assess the quality of life of patients with lower urinary tract disorders. Overactive bladder symptoms. Timepoint: At the beginning of the study and 3 months after the start of the intervention. Method of measurement: Using the overactive bladder symptoms evaluation questionnaire. Mashhad University of Medical Sciences Approved 2023-05-09 Ethics Committee of Mashhad University of Medical Sciences Faculty of Medicine, Mashhad University of Medical Sciences, Vakil Abad Boulevard, Mashhad, Khorasan Razavi, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)