]>
IRCT20210207050277N1 IRCT 2021-03-13 Ahvaz University of Medical Sciences The effect of Drug therapy on the treatment of overactive Bladder in Multiple Sclerosis, The effect of Physiotherapy on the treatment of overactive Bladder in Multiple Sclerosis Ms Comprasion of efficacy of Drug therapy(Solifenacin Succinate) and physiotherapy(Stimulation of Posterior Tibialis Nerve) on treatment of overactive Bladder and quality of life in Patients with Multiple Sclerosis 2021-03-21 anticipated 70 Complete https://irct.ir/trial/54196 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using the random block method, both people are randomly assigned to one of the two groups with the help of random codes generated. The size of the blocks is considered to be equal to 2, and inside each block, two random codes, one for group one and the other for group 2, are generated randomly. This is done with the help of random allocation https://www.sealedenvelope.com done, Blinding description: In this single blind study, Participants and Outcome assessors are aware of the type of study, but Researchers and Data analyzer are not aware of the type of intervention. 2 Condition 1: Multiple sclerosis. Condition 2: Overactive Bladder Disorder. Intervention 1: First Intervention group: Drug treatment The oral tablet of Sulifenacin succinate 5 mg under the brand name Vsol (Abidi Company) is used. It was developed in 2004 and is one of the antimuscarinic drugs that works by reducing bladder contractions. It is initially given at a dose of 5 mg daily for 4 weeks. Then increase the dose to 10 mg per day (5 mg twice daily) if the patient tolerates and lasts for 8 to 12 weeks. Intervention 2: Second Intervention group: Electrical stimulation of the posterior tibial nerve using a dual-channel x733 stimulator device with a model of 1396 and made in Iran will be applied. The current characteristics used will be as follows: intensity 0.5 to 10 mA, frequency 20 Hz, pulse length 200 microseconds.However, the intensity of the stimulation will increase to the threshold of motor nerve stimulation, which is characterized by flexion of the first toe. So far, no side effects have been reported on superficial electrical stimulation of the posterior tibial nerve. For electrical stimulation, the negative electrode (cathode) is placed behind the inner ankle and the positive electrode (anode) is 10 cm above the cathode. The number of posterior tibial nerve stimulation sessions will be 12 sessions in 12 weeks (one session per week) and the duration of each session will be 30 minutes. Yes - There is a plan to make this available What will be shared: After defending the dissertation and approval by Ahwaz University of Medical Sciences, the collected data (after identifying the participants) will be fully available to researchers and patients. When: Access period starts six months after the results are published To whom: If requested, the results will be available to other researchers working in academic and scientific institutions. Conditions: The information of this trial will be provided to researchers and patients with the aim of improving the quality of life of patients with multiple sclerosis. Where to obtain: Receiving documents will be possible by sending an email to the person in charge of the update. How to obtain: Documents will be emailed over a ten-day period. Comments:
public Mohammad Jafari
Department of Neurology, Golestan Hospital, Farvardin Street, Golestan
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 61 3377 3012 dr.mohammadjafari1368@gmail.com Ahvaz University of Medical Sciences scientific Mohammad Jafari
Department of Neurology, Golestan Hospital, Farvardin Street, Golestan
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 61 3377 3012 dr.mohammadjafari1368@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) No infection in the Urinary tract Have a minimum score of 3 in the Actionable questionnaire to confirm Neurogenic overactive Bladder Urinary incontinence that may or may not be accompanied by urgent Urinary incontinence At least 1 month has passed since the onset of symptoms of overactiveBladder disorder At least one month has passed since the last MS attack EDSS scale (severity of degree of disability) 1 to 5.5 no limit no limit Both Pregnant Women and those who want to get Pregnant within the next year Allergy to the Drug Sulifenacin such as Angioedema Heart problems (such as Heart failure) Have a history of surgery to treat Urinary incontinence or other Urinary tract surgeries Having stress Urinary incontinence Having Diabetes and Neurological diseases such as Parkinson's History of Anticholinergic Drug therapy for the treatment of overactive Bladder during the last month History of Electrotherapy treatment in the lower limbs and lower back and history of Pelvic floor Muscle Physiotherapy during a recent month Having a Heart Pacemaker and a Prosthesis in the leg Having a lesion at the site of Electrical stimulation of the Posterior Tibial Nerve G35 N32 Multiple sclerosis Other disorders of bladder Treatment - Drugs Treatment - Devices First Intervention group: Drug treatment The oral tablet of Sulifenacin succinate 5 mg under the brand name Vsol (Abidi Company) is used. It was developed in 2004 and is one of the antimuscarinic drugs that works by reducing bladder contractions. It is initially given at a dose of 5 mg daily for 4 weeks. Then increase the dose to 10 mg per day (5 mg twice daily) if the patient tolerates and lasts for 8 to 12 weeks. Second Intervention group: Electrical stimulation of the posterior tibial nerve using a dual-channel x733 stimulator device with a model of 1396 and made in Iran will be applied. The current characteristics used will be as follows: intensity 0.5 to 10 mA, frequency 20 Hz, pulse length 200 microseconds.However, the intensity of the stimulation will increase to the threshold of motor nerve stimulation, which is characterized by flexion of the first toe. So far, no side effects have been reported on superficial electrical stimulation of the posterior tibial nerve. For electrical stimulation, the negative electrode (cathode) is placed behind the inner ankle and the positive electrode (anode) is 10 cm above the cathode. The number of posterior tibial nerve stimulation sessions will be 12 sessions in 12 weeks (one session per week) and the duration of each session will be 30 minutes. Severity of Urinary Symptoms. Timepoint: Evaluation of urinary symptoms at the beginning of the study (before the intervention) and 4, 8 and 12 weeks after the intervention. Method of measurement: International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB). Urinary Incontinence. Timepoint: Evaluation of urinary incontinence at the beginning of the study (before the intervention) and 4, 8 and 12 weeks after the intervention. Method of measurement: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form(ICIQ-UI SF). Quality Of Life. Timepoint: Evaluation of Quality of life at the beginning of the study (before the intervention) and 4, 8 and 12 weeks after the intervention. Method of measurement: Multiple Sclerosis Quality of Life Questionnaire (MSQOL-54). Ahvaz University of Medical Sciences Approved 2020-12-22 Ethics committee of Ahwaz Jundishapur University of Medical Sciences Department of Neurology, Golestan Hospital, Farvardin Street, Golestan Ahvaz Khouzestan Iran (Islamic Republic of)