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IRCT20240821062824N1 IRCT 2025-02-24 Tarbiat Modares University The Co-effect of the Sensate Focus Technique and Pelvic Floor Muscle Exercises on the SexualFunction in Married Women with Stress Urinary Incontinence (SUI). The Co-effect of the Sensate Focus Technique and Pelvic Floor Muscle Exercises on the SexualFunction in Married Women with Stress Urinary Incontinence (SUI). 2025-02-28 anticipated 60 Complete https://irct.ir/trial/78657 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: This study will be a randomized controlled clinical trial. The study units will be 60 married women eligible for the study who will be invited to the office following a telephone call from the researcher. After marrying women with stress urinary incontinence refer to the clinic, the research units will explain the objectives, confidentiality of responses, providing general information, and autonomy at each stage of the study. After obtaining written informed consent, they will be asked to complete the demographic fertility questionnaires and the FSFI questionnaire. The researcher will assess the pelvic floor muscles using the pelvic floor muscle assessment checklist (modified Oxford scoring system). The subjects will be instructed to complete the urinary event recording table 24 hours a day until the end of the intervention period. In the second stage, subjects will be divided into intervention and control groups using a block randomization method using four-person random blocks, in such a way that the block list will be written and numbers will be assigned to them. Due to the two-group study, there were six different modes for the four-person blocks, so random numbers between one and six were selected and finally the intervention allocation list was determined based on the random numbers (BABA-BBAA-AABB-….) will be conducted. Opaque envelopes in a numbered order will be used to conceal the allocation. The researcher will randomly select the envelopes and then enter the research units into the sampling system in order. In the intervention group, an in-person training session will be held in the form of theoretical training on sensory focus techniques and pelvic floor exercises, along with the presentation of slides and educational videos. This two-hour workshop will be held individually in a room confidentially and quietly, and a step-by-step guide to sensory focus exercises and pelvic floor exercises will be provided to the samples. One month later and two months later, the research units will be contacted to come for evaluation and, if necessary, further explanations will be provided to them and their questions will be answered, Blinding description: Blinding will be done on participants and researcher.The research units are divided into two intervention and control groups using block randomization method and using random blocks of four, in such a way that the list of blocks is written and numbers are assigned to them. According to the two-group study, there were six different modes for the blocks of four, so random numbers between one and six were selected and finally the intervention allocation list is determined based on random numbers (BABA-BBAA-AABB-….). To hide the allocation, opaque envelopes are used in numerical order. The researcher randomly selects the envelopes and then enters the research units into the sampling system in order. N/A Stress Urinary Incontinence. Intervention 1: Intervention group: In the second stage, after randomly dividing the subjects into intervention and control groups, an in-person training session will be held in the intervention group in the form of theoretical training on sensory focus techniques and pelvic floor exercises, along with slides and educational videos. This two-hour workshop will be held individually in a room in a confidential and quiet manner, and a step-by-step guide to sensory focus exercises and pelvic floor exercises will also be made available to the samples. One month later and two months later, the research units will be contacted to come for evaluation and, if necessary, further explanations will be provided to them and their questions will be answered. The contact numbers and addresses of the participants will be recorded for access to the samples and follow-up assessments, and the researcher's contact number will also be made available to the samples to answer any possible questions. In the third stage, following the intervention, the researcher will contact the research units in the intervention group every week to ensure that sensory focus exercises and pelvic floor exercises are performed. The evaluation of the research units will be conducted in person 1 and 2 months after the intervention by completing the aforementioned questionnaires. If any side effects related to the exercises are observed, the relevant side effects will be recorded and necessary follow-up will be carried out. Intervention 2: Control group: In the second stage, after dividing the subjects into intervention and control groups by block randomization, the control group will only be taught pelvic floor exercises along with slides and educational videos, and a step-by-step guide to pelvic floor exercises will be provided to the samples. One month later and two months later, the research units will be contacted to come for evaluation and, if necessary, further explanations will be given to them and their questions will be answered. The contact number and address of the participants will be recorded for access to the samples and follow-up evaluations, and the researcher's contact number will also be available to the samples to answer any possible questions. At the end of the evaluation period, the control group will be provided with a sensory focus exercise educational booklet, and if they wish, an in-person sensory focus exercise educational session will also be held for them. If any side effects related to the exercises are observed, the relevant side effects will be recorded and the necessary follow-up will be carried out. Yes - There is a plan to make this available What will be shared: Part of the data, such as information related to the questionnaire file When: "Access period begins 6 months after results are published." To whom: Researchers working in academic and scientific institutions. Conditions: It is permitted if used for reference and the source is cited. Where to obtain: Researcher naghavi.fatemeh@modares.ac.ir How to obtain: After sending the email requesting the documents, they will be sent after reviewing the matter. Comments:
public Sayyed Fatemeh Naqavi
No. 53, North Amirabad, Shahrivar Street
Tehran Iran (Islamic Republic of) ۱۴۱۱۷۱۶۹۱۱ +98 921 384 5277 naghavi.fatemeh@modares.ac.ir Tarbiat Modares University scientific Sayyed Fatemeh Naqavi
No. 53, North Amirabad, Shahrivar Street
Tehran Iran (Islamic Republic of) ۱۴۱۱۷۱۶۹۱۱ +98 921 384 5277 naghavi.fatemeh@modares.ac.ir Tarbiat Modares University Iran (Islamic Republic of) Iran (Islamic Republic of) Iranian married women Having sex in the last 8 weeks No known underlying disease other than stress urinary incontinence. Not having a mental illness. Husband's monogamy and living with spouse currently and during the study. Persian language reading and writing skills The couple's lack of addiction to drugs and alcohol No stressful event within the past month No history of pelvic floor surgery. Not taking medications that affect sexual function 18 years 49 years Female Having underlying diseases Unmarried N39.3 Stress incontinence (female) (male) N/A N/A Intervention group: In the second stage, after randomly dividing the subjects into intervention and control groups, an in-person training session will be held in the intervention group in the form of theoretical training on sensory focus techniques and pelvic floor exercises, along with slides and educational videos. This two-hour workshop will be held individually in a room in a confidential and quiet manner, and a step-by-step guide to sensory focus exercises and pelvic floor exercises will also be made available to the samples. One month later and two months later, the research units will be contacted to come for evaluation and, if necessary, further explanations will be provided to them and their questions will be answered. The contact numbers and addresses of the participants will be recorded for access to the samples and follow-up assessments, and the researcher's contact number will also be made available to the samples to answer any possible questions. In the third stage, following the intervention, the researcher will contact the research units in the intervention group every week to ensure that sensory focus exercises and pelvic floor exercises are performed. The evaluation of the research units will be conducted in person 1 and 2 months after the intervention by completing the aforementioned questionnaires. If any side effects related to the exercises are observed, the relevant side effects will be recorded and necessary follow-up will be carried out. Control group: In the second stage, after dividing the subjects into intervention and control groups by block randomization, the control group will only be taught pelvic floor exercises along with slides and educational videos, and a step-by-step guide to pelvic floor exercises will be provided to the samples. One month later and two months later, the research units will be contacted to come for evaluation and, if necessary, further explanations will be given to them and their questions will be answered. The contact number and address of the participants will be recorded for access to the samples and follow-up evaluations, and the researcher's contact number will also be available to the samples to answer any possible questions. At the end of the evaluation period, the control group will be provided with a sensory focus exercise educational booklet, and if they wish, an in-person sensory focus exercise educational session will also be held for them. If any side effects related to the exercises are observed, the relevant side effects will be recorded and the necessary follow-up will be carried out. SexualFunction. Timepoint: Sexual function will be assessed by the researcher at the beginning of the study (before the intervention) and repeated 1-2 months after the intervention. Method of measurement: Sexual function will be assessed by the researcher at the beginning of the study (before the intervention) using the FSFI questionnaire and will be repeated 1-2 months after the intervention. Pelvic floor muscle strength. Timepoint: Before the start of the intervention, 1 month and 2 months after the start of the intervention. Method of measurement: Pelvic floor muscle assessment checklist. Tarbiat Modares University Approved 2025-01-25 Ethics committee of Tarbiat Modares University No. 53, Shahrivar Street, North Amirabad, Tehran Tehran Tehran Iran (Islamic Republic of)