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IRCT20241014063359N1 IRCT 2024-10-31 University of social welfare and rehabilitation sciences Investigating the effect of radiofrequency and biofeedback in urinary incontinence and impotence Investigating the effect of pelvic floor muscle training exercises along with radiofrequency or biofeedback compared to pelvic floor muscle training exercises alone on urinary incontinence and sexual dysfunction in women with urinary incontinence. 2024-11-18 anticipated 45 Complete https://irct.ir/trial/79636 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The grouping method is also a type of random grouping in the block method where people are placed in three groups. In the current clinical trial study (two intervention groups and one control group), it will include 45 samples, which will be done with the block randomization method according to the following process. The size of the used block is 3, and therefore, the combination of these modes for the control group and the patient groups, which are displayed with the letters C, T1 and T2 respectively, will include 6 modes. which will include (T2T1C, T1T2C, T1CT2, CT2T1, and CT1T2, T2CT1, ). Blocks will be selected randomly and with the help of Excel software, so that 10 blocks are randomly selected, and therefore 45 samples can be included in the study in a random sequence, which can be included in each control and treatment group. The number of blocks and how they are executed are done by hiding them inside the envelope. In this method, the blocks are numbered based on a random sequence and placed inside the envelopes, and the researcher assigns them to the intervention and treatment groups based on the order of arrival of the patients, 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 and the person analyzing the data are blind to the grouping of the participants. N/A Urinary incontinence. Intervention 1: Intervention group: The RF+ PFMT group receives five radiofrequency therapy sessions as weekly sessions, with the settings that will be mentioned below, and 15 sessions of pelvic floor muscle strengthening exercises during 5 weeks. At first, patients will perform 3 exercises to strengthen the pelvic floor muscles. In radiofrequency treatment, using a standard technique in which the tip of the intravaginal probe of the device is moved back and forth on the mucosal surface of the vagina and the entire front wall of the vagina using a special probe slowly with wide movements in the treated area, and radiofrequency energy and will remain in direct contact with the tissue for 10 minutes at a temperature of 43°C (between 41 and 45°C based on patient tolerance). Bipolar radiofrequency with a frequency of one megahertz, maximum power of 65 watts will be applied to patients. The radio frequency power will be adjusted to maintain the required temperature. Intervention 2: Intervention group: The Biofeedback+PFMT group receives fifteen therapeutic sessions of pelvic floor muscle strengthening exercises with biofeedback during 5 weeks.At the beginning of the pelvic floor muscle strengthening exercises, patients are given the necessary anatomical information with the help of biofeedback, and the exercises are taught one-on-one by the therapist. Patients are asked to empty their bladder before the procedure. They lie on their backs with their knees slightly bent and their heads slightly raised. Surface EMG probes are placed on the perineum at the three and nine o'clock positions, an additional neutral probe is placed on the patella, and patients are observed. Patients are asked to contract only their pelvic floor muscles, not their abdominal muscles. They are also asked to track the contraction and relaxation of their pelvic floor muscles on a monitor to make sure they are contracting the correct muscle group. Therefore, it enables active participation in the educational program. In this way, patients are taught how to identify their pelvic floor muscles and how to use their pelvic floor muscles selectively without using their abdominal muscles. After training the correct contraction, the patients are asked to do three pelvic floor muscle strengthening exercises. Intervention 3: The PFMT group receives fifteen therapeutic sessions of pelvic floor muscle strengthening exercises during 5 weeks.Patients are asked to perform the following three exercises based on the exercise program table.Faucet exercise: repeatedly contract and release your pelvic floor (such as closing and opening the faucet)- Elevator exercise: slowly contract the pelvic floor for 5 counts - hold for 5 counts - release for 5 counts (such as going up in the elevator for 5 counts - holding for 5 counts at the top floor - coming down with a count of 5) - Coughing or sneezing. Yes - There is a plan to make this available What will be shared: Total potential data after de-identifying individuals When: The access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: For use in systematic review studies and meta-analysis Where to obtain: Zahraardekanipt@gmail.com How to obtain: Please send your written request and a full description of the reason for the data request to the email address provided. After reviewing your request, your email will be answered within ten working days. Comments:
public Nahid Rahmani
Physiotherapy Educational Department, 5th Floor, University of Rehabilitation Sciences and Social Health, Koodakyar St, Daneshjoo Blvd, EvinFarabi Building,
Tehran Iran (Islamic Republic of) 1985713871 +98 21 7173 2895 nahrah2005@yahoo.com University of social welfare and rehabilitation sciences scientific Nahid Rahmani
Physiotherapy Educational Department, 5th Floor, University of Rehabilitation Sciences and Social Health, Koodakyar St, Daneshjoo Blvd, EvinFarabi Building,
Tehran Iran (Islamic Republic of) 1985713871 +98 21 7173 2895 nahrah2005@yahoo.com University of social welfare and rehabilitation sciences Iran (Islamic Republic of) - Women aged 35 to 55 with urinary incontinence as the main clinical complaint, whose urine loss of more than 1 gram per hour can be confirmed by the test pad, and who have sexual disorders and impotence at the same time. 35 years 55 years Female Patients with chronic degenerative diseases that affect muscle and nerve tissues. Presence of any degree of pelvic organ prolapse Active or frequent urinary tract infections Vulvovaginitis Atrophic vaginitis Absence of a copper IUD in the uterus Patients who are pregnant or have given birth less than 6 months ago. Type 1 and 2 diabetes neurological disease Mental illness taking drugs that affect urination History of surgical or drug treatment for urinary incontinence Chronic debilitating diseases such as kidney failure Those who have a pacemaker. If the patient does not want to continue to cooperate at any stage of the study, does not complete the treatment sessions, and the patient's condition changes in such a way that they lose any of the entry criteria, the participants will be excluded from the study. R32 Unspecified urinary incontinence Rehabilitation Rehabilitation Rehabilitation Intervention group: The RF+ PFMT group receives five radiofrequency therapy sessions as weekly sessions, with the settings that will be mentioned below, and 15 sessions of pelvic floor muscle strengthening exercises during 5 weeks. At first, patients will perform 3 exercises to strengthen the pelvic floor muscles. In radiofrequency treatment, using a standard technique in which the tip of the intravaginal probe of the device is moved back and forth on the mucosal surface of the vagina and the entire front wall of the vagina using a special probe slowly with wide movements in the treated area, and radiofrequency energy and will remain in direct contact with the tissue for 10 minutes at a temperature of 43°C (between 41 and 45°C based on patient tolerance). Bipolar radiofrequency with a frequency of one megahertz, maximum power of 65 watts will be applied to patients. The radio frequency power will be adjusted to maintain the required temperature. Intervention group: The Biofeedback+PFMT group receives fifteen therapeutic sessions of pelvic floor muscle strengthening exercises with biofeedback during 5 weeks.At the beginning of the pelvic floor muscle strengthening exercises, patients are given the necessary anatomical information with the help of biofeedback, and the exercises are taught one-on-one by the therapist. Patients are asked to empty their bladder before the procedure. They lie on their backs with their knees slightly bent and their heads slightly raised. Surface EMG probes are placed on the perineum at the three and nine o'clock positions, an additional neutral probe is placed on the patella, and patients are observed. Patients are asked to contract only their pelvic floor muscles, not their abdominal muscles. They are also asked to track the contraction and relaxation of their pelvic floor muscles on a monitor to make sure they are contracting the correct muscle group. Therefore, it enables active participation in the educational program. In this way, patients are taught how to identify their pelvic floor muscles and how to use their pelvic floor muscles selectively without using their abdominal muscles. After training the correct contraction, the patients are asked to do three pelvic floor muscle strengthening exercises. The PFMT group receives fifteen therapeutic sessions of pelvic floor muscle strengthening exercises during 5 weeks.Patients are asked to perform the following three exercises based on the exercise program table.Faucet exercise: repeatedly contract and release your pelvic floor (such as closing and opening the faucet)- Elevator exercise: slowly contract the pelvic floor for 5 counts - hold for 5 counts - release for 5 counts (such as going up in the elevator for 5 counts - holding for 5 counts at the top floor - coming down with a count of 5) - Coughing or sneezing Performance (strength and tolerance) of the pelvic floor muscles. Timepoint: Before the start of the intervention, the end of the last session of the intervention, one month later. Method of measurement: using perineometer device. The quantitive amount of urine lost. Timepoint: Before the start of the intervention, the end of the last session of the intervention, one month later. Method of measurement: using one hour pad test. Incontinence symptoms and sexual function. Timepoint: Before the start of the intervention, the end of the last session of the intervention, one month later. Method of measurement: Using the valid Persian version of ICIQ-SF, ICIQ-VS, FSFI questionnaires. Satisfaction with treatment. Timepoint: Before the start of the intervention, the end of the last session of the intervention, one month later. Method of measurement: using Likert scale. University of social welfare and rehabilitation sciences Approved 2024-07-02 Ethics Committee of the University of Rehabilitation Sciences and Social Health University of Rehabilitation Sciences and Social Health, kodakyar Dead End, Daneshjoo boulevard, Velenjak Tehran Tehran Iran (Islamic Republic of)