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IRCT20201214049719N1 IRCT 2021-02-16 Iran University of Medical Sciences Effects of vaginal cones along with the Knack manouvre on urinary stress incontinence Effects of pelvic floor muscle training with vaginal cones along with The Knack manouvre on the severity of incontinence and quality of life in women with urinary stress incontinence 2021-02-19 anticipated 76 Complete https://irct.ir/trial/53001 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: 76 participants are screened with competence and by random allocation of 4 blocks as follows, they are divided into two groups of intervention and control. Block1: AABB Block2: ABBA Block3: ABAB Block4: BABA Block5: BBAA Block6: BABA We write 6 modes on 6 cards and pick one of these cards by accident. N/A Stress urinary incontinence. Intervention 1: Intervention group: First, the size of the cone that each patient should use to start training is determined by vaginal examination with two fingers. The appropriate cone is gently inserted into the female vagina by the researcher in the dorsal recumbent position while the tip of the cone and its nylon thread point down. Will be placed. If the participant's vagina is larger than two fingers in diameter, it will most likely be difficult for her to hold the small cone, in which case we will start with the larger cone. If the cone is inserted correctly, the participant should feel comfortable and the cone should not move. From now on, the weight is added to the empty cone. We start with the lowest value and whenever the patient is able to hold the cone with that weight inside his vagina, we try the heavier weight so that eventually the patient can no longer hold that weight in his vagina. With this amount of weight, the patient should start his exercises from the open arch position. In this case, we instruct the patient to try to hold the weight for 5 seconds and gradually 10 seconds by contracting the vaginal area (ie, contracting and pulling up the pelvic floor muscles). When he could easily hold the weight for 10 seconds, then he practiced standing. In this case, too, he should hold the cone in his vagina by contracting the pelvic floor muscles. The contraction time also gradually increases from 5 seconds to 10 seconds. Once the patient is able to easily hold the cone in a standing position for 10 seconds, he or she can progress the exercise and gradually keep the cone from 5 seconds to 10 seconds while walking by contracting the pelvic floor muscles. It should be noted that the patient should relax the pelvic floor muscles for ten seconds after every 5 to 10 seconds of contraction. Exercise is done twice a day for 3 to 10 minutes at a time. When a person can easily hold the cone while walking for 10 seconds, he can start with a heavier weight in the open arch position, and similarly, the patient can exercise by increasing the weight and changing the position, ie standing from the open arch and walking position. Develops. In addition to training the pelvic floor muscles by the vaginal cone, the intervention group is also trained in maneuvering. In this way, the pelvic floor physiotherapist teaches the participant that any activity that is associated with increased intra-abdominal pressure, such as coughing, sneezing, lifting heavy weights, climbing stairs, or similar activities, first and foremost. Before that activity occurs, contract the pelvic floor activity and gradually try to contract the pelvic floor muscles at the exact moment the activity occurs, thus improving the maneuver. Intervention 2: Control group: The participants of the control group also follow the same treatment protocol (similar to the intervention group) without maneuvering for 12 weeks. Patients are asked to record the time of weight gain and change in their position in each amount of weight in the relevant table. 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 Leila Parsamoin
Tehran School of Nursing and Midwifery, Rashid Yasemi St., after Vanak Square, Vali Asr St.
Tehran Iran (Islamic Republic of) 1498753634 +98 21 4473 7015 leila.parsamoin@gmail.com Iran University of Medical Sciences scientific Leila Parsamoin
Tehran School of Nursing and Midwifery, Rashid Yasemi St., after Vanak Square, Vali Asr St., Tehran
Tehran Iran (Islamic Republic of) 1498753634 +98 21 4473 7015 lela.parsamoin@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Existence of stress urinary incontinence (without emergency incontinence) based on the patient's own statements, by filling out a standardized questionnaire to diagnose urinary incontinence (QUID) Having a leak of urine with at least one episode during the last month Age 30 to 70 years No uncontrolled blood pressure No surgical history due to incontinence No chronic degenerative diseases that affect nerve and muscle tissue (diabetes, MS) No history of childbirth in less than two months Not pregnant 30 years 70 years Female Advanced urogenital prolapse (stage III - stage IV) Existence of urogenital infection Receive any treatment (pharmacological and physical) for incontinence during the study Inability to perform the proposed methods Patient dissatisfaction with continued cooperation with the research team N39.3 Stress incontinence Rehabilitation Rehabilitation Intervention group: First, the size of the cone that each patient should use to start training is determined by vaginal examination with two fingers. The appropriate cone is gently inserted into the female vagina by the researcher in the dorsal recumbent position while the tip of the cone and its nylon thread point down. Will be placed. If the participant's vagina is larger than two fingers in diameter, it will most likely be difficult for her to hold the small cone, in which case we will start with the larger cone. If the cone is inserted correctly, the participant should feel comfortable and the cone should not move. From now on, the weight is added to the empty cone. We start with the lowest value and whenever the patient is able to hold the cone with that weight inside his vagina, we try the heavier weight so that eventually the patient can no longer hold that weight in his vagina. With this amount of weight, the patient should start his exercises from the open arch position. In this case, we instruct the patient to try to hold the weight for 5 seconds and gradually 10 seconds by contracting the vaginal area (ie, contracting and pulling up the pelvic floor muscles). When he could easily hold the weight for 10 seconds, then he practiced standing. In this case, too, he should hold the cone in his vagina by contracting the pelvic floor muscles. The contraction time also gradually increases from 5 seconds to 10 seconds. Once the patient is able to easily hold the cone in a standing position for 10 seconds, he or she can progress the exercise and gradually keep the cone from 5 seconds to 10 seconds while walking by contracting the pelvic floor muscles. It should be noted that the patient should relax the pelvic floor muscles for ten seconds after every 5 to 10 seconds of contraction. Exercise is done twice a day for 3 to 10 minutes at a time. When a person can easily hold the cone while walking for 10 seconds, he can start with a heavier weight in the open arch position, and similarly, the patient can exercise by increasing the weight and changing the position, ie standing from the open arch and walking position. Develops. In addition to training the pelvic floor muscles by the vaginal cone, the intervention group is also trained in maneuvering. In this way, the pelvic floor physiotherapist teaches the participant that any activity that is associated with increased intra-abdominal pressure, such as coughing, sneezing, lifting heavy weights, climbing stairs, or similar activities, first and foremost. Before that activity occurs, contract the pelvic floor activity and gradually try to contract the pelvic floor muscles at the exact moment the activity occurs, thus improving the maneuver. Control group: The participants of the control group also follow the same treatment protocol (similar to the intervention group) without maneuvering for 12 weeks. Patients are asked to record the time of weight gain and change in their position in each amount of weight in the relevant table. Severity of urinary incontinence. Timepoint: At the beginning of the study (before the intervention) and 12 weeks after the intervention. Method of measurement: Urinary Diary. Incontinence quality of life. Timepoint: At the beginning of the study (before the intervention) and 12 weeks after the intervention. Method of measurement: Incontinence quality of life questionnaire. The rate of involuntary leakage of urine during stress. Timepoint: Before the start of the study (before the intervention), 12 weeks after the intervention. Method of measurement: Urinary diary. Number of leaks. Timepoint: Before the start of the study (before the intervention), 12 weeks after the intervention. Method of measurement: Urinary diary. The strength of the pelvic floor muscles. Timepoint: Before the start of the study (before the intervention), 12 weeks after the intervention. Method of measurement: Dynamometer. Iran University of Medical Sciences Approved 2020-12-13 Ethics committee of Iran University of Medical Sciences Fifth Floor, Headquarters of Iran University of Medical Sciences, between Chamran and Sheikh Fazlollah, Hemmat Highway, Tehran Tehran Iran (Islamic Republic of)