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IRCT20210415050979N1 IRCT 2022-06-06 Shahid Beheshti University of Medical Sciences The Efficacy of Electro-acupuncture with Kinesiotape in Patients with Urinary Incontinence The Efficacy of Electro-acupuncture with Kinesiotape Compared to Biofeedback for Controlling Urinary Symptoms in Patients with Urinary Incontinence 2022-05-22 anticipated 60 Complete https://irct.ir/trial/55665 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this clinical trial study, 60 patients with complications related to urinary incontinence will be included in the study. For random allocation of individuals in the study groups (intervention group and comparison group), the method of random allocation with block method (Block Randomization) will be used. In this method, blocks with a size of six (including three people in the intervention group and three people in the comparison group) with a ratio of 1:1 will be used. Random Allocation software will be used to generate random sequences. The random allocation concealment method is used in such a way that random sequences are created. In this method, they are identified on the cards and these cards are placed inside the sealed envelopes in order. In order to maintain the created sequence, the numbering will be recorded on the outer surface of the envelopes. Finally, the numbered envelopes will be placed in a folder. Then, according to the order of entry of the eligible participants, the envelopes will be opened and the assigned group of the participant will be determined, Blinding description: Participants would not be aware of the intervention and control groups in this study. N/A Condition 1: Stress incontinence. Condition 2: Urge incontinence. Intervention 1: People in the first group are treated with electroacupuncture for 5 sessions for 20 minutes. During this period, patients are subjected to continuous stimulation for 10 minutes and pulsed stimulation for 10 minutes via an acupuncture needle. 4 needles are placed at the same distance from the ASIS area to the tubercle pubic area. The needles are spaced from the pulse of the artery. At the end of each treatment session, all members of this group are treated with pelvic floor kinesiotype. Pelvic floor typing is from pubic tubercle to ASIS, which is without tension on both sides and 50% in the middle with tension. All patients were instructed in how to care for the kinesiotype, and did not separate the kinesiotype until the next treatment session. Intervention 2: The second group is treated with biofeedback for 5 sessions of 20 minutes, which includes 10 minutes of electrical stimulation and 10 minutes of active muscle contraction with auditory and visual feedback. These stimulations are applied through a rectal probe in accordance with health standards. 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 more information
public Najme Sadat Bolandnazar
Shahid Rajabnia street, Shoush squre, Tehran
Tehran Iran (Islamic Republic of) 1185817311 +98 21 5506 2628 sajede.mousavi72@gmail.com Shahid Beheshti University of Medical Sciences scientific Najme sadat Bolandnazar
Shahid Rajabnia street, Shoush square, Tehran
Tehran Iran (Islamic Republic of) 1185817311 +98 21 5506 2628 sajede.mousavi72@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with urinary stress or urgent incontinence Patients with a history of at least three months of urinary incontinence complications Women aged between 20 to 80 years 20 years 80 years Female Patients with , upper motor neuron disease, such as cerebral palsy, multiple sclerosis, Stroke, spinal cord injury Recent perineal trauma(Less than three months ago) History of genital surgery diabetes mellitus N39.3 N39.41 Stress incontinence (female) (male) Urge incontinence Treatment - Other Treatment - Other People in the first group are treated with electroacupuncture for 5 sessions for 20 minutes. During this period, patients are subjected to continuous stimulation for 10 minutes and pulsed stimulation for 10 minutes via an acupuncture needle. 4 needles are placed at the same distance from the ASIS area to the tubercle pubic area. The needles are spaced from the pulse of the artery. At the end of each treatment session, all members of this group are treated with pelvic floor kinesiotype. Pelvic floor typing is from pubic tubercle to ASIS, which is without tension on both sides and 50% in the middle with tension. All patients were instructed in how to care for the kinesiotype, and did not separate the kinesiotype until the next treatment session. The second group is treated with biofeedback for 5 sessions of 20 minutes, which includes 10 minutes of electrical stimulation and 10 minutes of active muscle contraction with auditory and visual feedback. These stimulations are applied through a rectal probe in accordance with health standards. Improvement percentage in urinary incontinence. Timepoint: Before, After treatment, 2 months after treatment. Method of measurement: International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS). Shahid Beheshti University of Medical Sciences Approved 2021-01-31 Ethics Committee of Shahid Beheshti University of Medical Sciences Shahid A'rabi street, Yemen blvd, Shahid Chamran highway Tehran Tehran Iran (Islamic Republic of)