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IRCT20230305057630N1 IRCT 2023-05-09 Semnan University of Medical Sciences Comparing the effects of biofeedback and brain stimulation treatments on pelvic floor muscle function in women with urinary incontinence Comparison of the effect of biofeedback and repetitive transcranial magnetic stimulation on pelvic floor muscles function in women with urinary incontinence 2023-05-20 anticipated 33 Complete https://irct.ir/trial/69899 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: To use the random number table, the researcher first determines the direction of reading the numbers in the table (up, down, left or right). The researcher will consider the numbers 00-24 for the biofeedback group, the numbers 25-49 for the rTMS group, and the numbers 50-74 for the PFMT group. Then the researcher puts her hand on one of the numbers and moves in one of the predetermined directions and records the numbers and assigns them to different groups, Blinding description: The patient receives the type of intervention or control group in sealed envelopes that are coded. Coding is done by one of the colleagues of the project. The evaluator is blind to the grouping of the participants and the participants are blind to the type of interventions of the opposite group. According to Pan et al.'s study in 2020 for the sham group, the subjects received the same number of stimuli whose parameters are the same as the active group. However, the coil is rotated 90 degrees and only 1 wing will be in contact with the edge on the scalp, producing the same sound. Patients will not be familiar with the difference between rTMS-Sham and active rTMS in acoustic and tactile aspects. N/A Urinary incontinence. Intervention 1: Control group: This group receives only routine exercises to strengthen the pelvic floor muscles, each session is 30 minutes and is divided into three parts: 1) Sustained contractions: Patients complete pelvic muscle contraction for 6-10 seconds each time, then start the next contraction after 10 seconds rest, 8-10 repetitions per set, 1-2 sets per session. 2)Phasic contractions: Patients complete pelvic muscle contraction for 2-5 seconds each time, then rest, rest time is twice the contraction time, 10 repetitions per set, 1-3 sets per session. 3) Guided training: Patients are asked to simulate activities such as coughing, sneezing while contracting the pelvic floor muscles. Treatment sessions will be held in 3 sessions per week for a total period of 3 weeks. Intervention 2: First intervention group: Pelvic floor muscle strengthening exercises with biofeedback : The treatment program includes 9 sessions of combined pelvic floor rehabilitation, that is, the combination of electromyographic biofeedback and progressive exercises of the pelvic floor muscles, will be used as a therapeutic exercise program. Biofeedback takes 15 minutes. A special vaginal probe of Leukoplast combination, which is the same for all patients, will be used for electromyographic biofeedback applications. Each probe will be unique to the patient. The patient will be given the necessary training to train the pelvic floor muscles alone and using vaginal cones in treatment sessions. According to the Kegel treatment protocol, 300 contractions are performed daily. Contraction of the pelvic floor by maintaining the vaginal cone while standing, lying down, sitting and going up and down the stairs as well as running will be done gradually at home with daily progress. Each patient's in-person treatment session will take 45 minutes to one hour. The treatment sessions will be performed 3 times a week for a total period of 3 weeks. Intervention 3: Second intervention group: Repetitive Transcranial Magnetic Stimulation (rTMS) : All participants use the same rTMS device, which has a figure-of-eight coil with the handle facing the sensorimotor cortex on one side. The physiotherapist chooses the pelvic floor muscle as the reference muscle for applying rTMS, and rTMS is applied to the Supplementary Motor Area (SMA) which corresponds to the pelvic floor muscles. Patients are positioned in the supine position and inhibitory rTMS is used for this group of patients on the SMA for 20 minutes each time. LF-rTMS is a inhibitory protocol consisting of 1 pulse per second applied continuously (2000 pulses in total). Treatment sessions will be held in 3 sessions per week for a total period of 3 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Maryam Miri Torbaghan
Neuromuscular Rehabilitation Research Center, Quds Blvd.
Semnan Iran (Islamic Republic of) 3519698375 +98 23 3332 8502 maryammiritorbaghan@gmail.com Semnan University of Medical Sciences scientific Dr. Atefeh Aminianfar
Neuromuscular Rehabilitation Research Center, Quds Blvd.
Semnan Iran (Islamic Republic of) 3519698375 +98 23 3332 8502 aminfar83@yahoo.com Semnan University of Medical Sciences Iran (Islamic Republic of) Women aged 35 to 70 years with urinary incontinence as the main clinical complaint, without urgent symptoms Urine loss of more than 1 gram per hour should be confirmed by a one-hour test pad The simultaneous presence of sexual disorders and impotence with urinary incontinence Absence of chronic degenerative diseases that affect muscle and nerve tissues Absence of any degree of pelvic organ prolapse (POP) Absence of active or recurrent urinary tract infections (UTIs) Absence of vulvovaginitis Absence of atrophic vaginitis Absence of copper IUD in the uterus Absence of pregnancy or childbirth less than 6 months Not suffering from diabetes, neurological disease, mental illness, and debilitating chronic diseases such as kidney failure and heart pacemakers. Absence of taking drugs that affect urination No history of surgical or drug treatment of SUI No history of abdominal and inguinal hernia No history of any surgery in the abdomen and pelvis (due to adhesions in the area and impact on the bladder) Absence of constipation No history of seizures 35 years 70 years Female Having a urinary infection History of cesarean section Unwillingness to cooperate Suffering from chronic degenerative diseases that affect muscle and nerve tissues Presence of any degree of pelvic organ prolapse (POP) Presence of active or recurrent urinary tract infections (UTIs) Presence of vulvovaginitis Presence of atrophic vaginitis Presence of a copper IUD in the uterus Pregnancy or childbirth less than 6 months Having diabetes, neurological disease, mental illness and debilitating chronic diseases such as kidney failure and heart pacemaker Presence of drugs that affect urination History of surgical or drug treatment of SUI History of abdominal and inguinal hernia Having a history of any surgery in the abdomen and pelvis (due to adhesions in the area and impact on the bladder) Presence of constipation History of seizures N39.3 Stress incontinence (female) (male) Rehabilitation Treatment - Devices Treatment - Devices Control group: This group receives only routine exercises to strengthen the pelvic floor muscles, each session is 30 minutes and is divided into three parts: 1) Sustained contractions: Patients complete pelvic muscle contraction for 6-10 seconds each time, then start the next contraction after 10 seconds rest, 8-10 repetitions per set, 1-2 sets per session. 2)Phasic contractions: Patients complete pelvic muscle contraction for 2-5 seconds each time, then rest, rest time is twice the contraction time, 10 repetitions per set, 1-3 sets per session. 3) Guided training: Patients are asked to simulate activities such as coughing, sneezing while contracting the pelvic floor muscles. Treatment sessions will be held in 3 sessions per week for a total period of 3 weeks. First intervention group: Pelvic floor muscle strengthening exercises with biofeedback : The treatment program includes 9 sessions of combined pelvic floor rehabilitation, that is, the combination of electromyographic biofeedback and progressive exercises of the pelvic floor muscles, will be used as a therapeutic exercise program. Biofeedback takes 15 minutes. A special vaginal probe of Leukoplast combination, which is the same for all patients, will be used for electromyographic biofeedback applications. Each probe will be unique to the patient. The patient will be given the necessary training to train the pelvic floor muscles alone and using vaginal cones in treatment sessions. According to the Kegel treatment protocol, 300 contractions are performed daily. Contraction of the pelvic floor by maintaining the vaginal cone while standing, lying down, sitting and going up and down the stairs as well as running will be done gradually at home with daily progress. Each patient's in-person treatment session will take 45 minutes to one hour. The treatment sessions will be performed 3 times a week for a total period of 3 weeks. Second intervention group: Repetitive Transcranial Magnetic Stimulation (rTMS) : All participants use the same rTMS device, which has a figure-of-eight coil with the handle facing the sensorimotor cortex on one side. The physiotherapist chooses the pelvic floor muscle as the reference muscle for applying rTMS, and rTMS is applied to the Supplementary Motor Area (SMA) which corresponds to the pelvic floor muscles. Patients are positioned in the supine position and inhibitory rTMS is used for this group of patients on the SMA for 20 minutes each time. LF-rTMS is a inhibitory protocol consisting of 1 pulse per second applied continuously (2000 pulses in total). Treatment sessions will be held in 3 sessions per week for a total period of 3 weeks. Evaluation of urinary incontinence and vaginal symptoms. Timepoint: Before and after the intervention and one month after the last treatment session. Method of measurement: International Consultation on Incontinence Questionnaire Vaginal Symptoms Module questionnaire. The volume of urine loss. Timepoint: Before and after the intervention and one month after the last treatment session. Method of measurement: One hour pad test. Bladder displacement amount. Timepoint: Before and after the intervention and one month after the last treatment session. Method of measurement: Ultrasonography. Strength and endurance of pelvic floor muscles. Timepoint: Before and after the intervention and one month after the last treatment session. Method of measurement: Perineometer. Strength and endurance of pelvic floor muscles. Timepoint: Before and after the intervention and one month after the last treatment session. Method of measurement: Manual assessment with the Oxford scale. Strength and endurance of pelvic floor muscles. Timepoint: Before and after the intervention and one month after the last treatment session. Method of measurement: Biofeedback. Semnan University of Medical Sciences Approved 2023-03-18 Research Ethics Committees of Semnan University Of Medical Sciences and Health Services Basij Blvd, Semnan University of Medical Sciences Semnan Semnan Iran (Islamic Republic of)