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IRCT20200710048069N1 IRCT 2020-09-01 Ahvaz University of Medical Sciences The effect of exercise therapy of trunk stabilizing muscles in women with stress urinary incontinence The effect of trunk stabilization training versus pelvic floor muscle training on the ultrasonography indices, clinical indices and quality of life in women with stress urinary incontinence: A Randomized Controlled Trial 2020-07-31 anticipated 46 Complete https://irct.ir/trial/49561 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The random sequence generation will be via restricted randomization (permuted block randomization) with random block size (block size: 2, 4, 6). Thus, participants in this study will be randomly assigned to one of the two control or experimental groups. The online randomization method (www.sealedenvelope.com) will be used to generate a random sequence. For allocation concealment, sequentially numbered, sealed, opaque envelopes will be used. This will be done with the help of someone who has no role in the research process. Based on the order of entry of eligible participants in the study, selected by gynecologists and urologists, one of the envelopes will be opened in order and the group allocation to that participant will be determined, Blinding description: The evaluator will not know about the group allocation of the participants in this study. Only the participants and the physical therapist involved in the training will know the group allocation. N/A stress urinary incontinence. Intervention 1: The intervention group, will perform the exercise program based on Sapsford's design in the 5 steps. These include: 1. diaphragmatic breathing exercise (in supine, sitting and standing positions), 2. tonic activation of the transverse abdominal muscle and pelvic floor muscles (in standing position), 3. strengthening of the transverse abdominal, pelvic floor muscles and internal oblique muscles (in standing position), 4. Functional expiratory patterns such as coughing and sneezing (in standing position), and 5. tonic contraction of the transverse abdominal and pelvic floor muscles during strenuous activity such as running and jumping.The exercises will perform 1-2 times a day for 8 weeks. Intervention 2: The control group will perform the exercise protocol included sub-maximal and maximal contraction of pelvic floor muscles. The participants will instruct to contract pelvic floor muscles in isolation and to prevent other muscles contraction, such as the hip and abdominal muscles. To perform the sub-maximal contraction, the participants should keep the pelvic floor muscles contraction as long as possible with moderate intensity. The exercises would be performed 1-2 times a day, with 8-12 repetitions and for 8 weeks. To perform maximum pelvic floor muscles contraction, the participants would keep the pelvic floor muscles at maximum contraction for 4-5 seconds. The contractions will perform 1-2 times a day with 8 repetitions, for 8 weeks. The position of exercise are supine and then will progress to sitting and standing positions. Yes - There is a plan to make this available What will be shared: outcome measurements can be shared. When: one week To whom: All researchers and students can access this data. Conditions: All researchers and students can access this data. Where to obtain: Applicants can send their request to maedeh.fani@gmail.com to receive documents or data. How to obtain: Documents and data files can be accessed by sending email to maedeh.fani@gmaail.com. Comments:
public Shahin Goharpey
Department of physical therapy, Faculty of rehabilitation sciences, Ahvaz Jundishapur University of Medical sciences, Golestan street
Ahvaz Iran (Islamic Republic of) 6135733133 +98 61 3374 3102 shgoharpey@yahoo.com Ahvaz University of Medical Sciences scientific Shahin Goharpey
Department of physical therapy, Faculty of Rehabilitation Sciences, Ahvaz Jundishapur University of Medical sciences, Golestan street
Ahvaz Iran (Islamic Republic of) 6135733133 +98 61 3374 3102 shgoharpey@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Women between the ages of 20 and 55 years old. Women who have experienced stress urinary incontinence at least once in the past month during activities that increase intra-abdominal pressure, such as coughing and sneezing. 20 years 55 years Female Pregnancy History of episiotomy History of systemic or neuromuscular or neurological disease History of surgery or recent rehabilitation for urinary incontinence Hysterectomy Concomitant treatment for urinary incontinence or low back pain Urinary tract infection Medications that exacerbate or alleviate the symptoms of urinary incontinence Severe low back pain or pelvic pain N39.3 Stress incontinence (female) (male) Rehabilitation Rehabilitation The intervention group, will perform the exercise program based on Sapsford's design in the 5 steps. These include: 1. diaphragmatic breathing exercise (in supine, sitting and standing positions), 2. tonic activation of the transverse abdominal muscle and pelvic floor muscles (in standing position), 3. strengthening of the transverse abdominal, pelvic floor muscles and internal oblique muscles (in standing position), 4. Functional expiratory patterns such as coughing and sneezing (in standing position), and 5. tonic contraction of the transverse abdominal and pelvic floor muscles during strenuous activity such as running and jumping.The exercises will perform 1-2 times a day for 8 weeks. The control group will perform the exercise protocol included sub-maximal and maximal contraction of pelvic floor muscles. The participants will instruct to contract pelvic floor muscles in isolation and to prevent other muscles contraction, such as the hip and abdominal muscles. To perform the sub-maximal contraction, the participants should keep the pelvic floor muscles contraction as long as possible with moderate intensity. The exercises would be performed 1-2 times a day, with 8-12 repetitions and for 8 weeks. To perform maximum pelvic floor muscles contraction, the participants would keep the pelvic floor muscles at maximum contraction for 4-5 seconds. The contractions will perform 1-2 times a day with 8 repetitions, for 8 weeks. The position of exercise are supine and then will progress to sitting and standing positions. Bladder base displacement. Timepoint: Before and after 8 weeks of intervention. Method of measurement: Trans-abdominal sonography. Voiding diary. Timepoint: Before and after 8 weeks of intervention. Method of measurement: Voiding diary. Pelvic floor muscle strength. Timepoint: Before and after 8 weeks of intervention. Method of measurement: Axford scale. Severity of urinary incontinence. Timepoint: Before and after 8 weeks of intervention. Method of measurement: Severity index. Quality of life. Timepoint: Before and after 8 weeks of intervention. Method of measurement: Quality of life questionnaire. Ahvaz University of Medical Sciences Approved 2018-12-09 Research Ethics Committee of Ahvaz Jundishapur University of Medical Sciences Research Ethics Committee of Ahvaz Jundishapur University of Medical Sciences, Ahvaz Jundishapur University of Medical Sciences, Golestan street Ahvaz Khouzestan Iran (Islamic Republic of)