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IRCT20110606006709N28 IRCT 2025-10-20 Tabriz University of Medical Sciences Comparison of the Effects of Pelvic floor muscle training, Foot Reflexology, and Their Combination on Stress Urinary Incontinence in Women PFMT Comparison of the Effects of Pelvic floor muscle training, Foot Reflexology, and Their Combination on Stress Urinary Incontinence in Women: A Randomized Controlled Trial 2025-11-06 anticipated 84 Complete https://irct.ir/trial/86346 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: Participants will be randomly assigned to one of the three intervention groups (reflexology alone, PFMT alone, or a combination of reflexology and PFMT) using a random number table with block sizes of six and nine and an allocation ratio of 1:1:1. Block randomization will be performed by an individual not involved in the sampling process. To ensure allocation concealment, the researcher or individuals responsible for patient assignment will prepare a series of sealed envelopes numbered consecutively from 1 to 84 before the start of the study. Each envelope will contain a random number or code corresponding to one of the treatment groups (PFMT alone, reflexology alone, or the combination of reflexology and PFMT). After each participant is enrolled in the study, one of the sealed envelopes will be assigned to them, and group allocation will be carried out confidentially, without the researcher’s knowledge. This method prevents allocation bias since the researcher remains unaware of the treatment group until after the participant has been assigned. Each intervention will be administered over a period of eight weeks, Blinding description: This study is a single-blind randomized controlled trial in which the data analyst will be unaware of the participants’ group allocation. 3 tress Urinary Incontinence. Intervention 1: Group 1 (PFMT): Participants assigned to the pelvic floor muscle training (PFMT) group will be instructed to perform the exercises as taught. Before starting the exercises, the bladder should be emptied. The exercises can be performed in different body positions—lying down with legs straight, sitting with the back upright, or standing with feet shoulder-width apart. To identify the muscles involved in urinary control, participants will be asked to try to stop the flow of urine once while urinating by contracting their pelvic floor muscles. This helps them recognize the correct muscles to use, and they will be advised not to repeat this maneuver more than once or twice to avoid the risk of urinary tract infections. During training, breathing should remain normal, and only the pelvic floor muscles should contract while the rest of the body stays relaxed. The PFMT program will be carried out for eight weeks. Each week, the exercises will be performed three times per day (morning, afternoon, and evening) on five to six days per week, allowing one rest day to accommodate individual lifestyles. In each session, three sets will be performed, with 10 to 15 repetitions per set, and each session will last approximately 15–20 minutes. The progression of exercises is structured as follows: during weeks 1 and 2, the focus will be on learning the correct technique, with each contraction held for 3 seconds followed by 3 seconds of rest between contractions, performed in the lying position. During weeks 3 and 4, the duration of contraction and relaxation will increase to 4 seconds each, with 12 repetitions per set, and the sitting position will be added. From weeks 5 to 8, each contraction and relaxation will last 5 seconds, with 15 repetitions per set, and exercises will be performed in three positions: lying, sitting, and standing. In addition to slow contractions, fast contractions will be introduced during the later weeks, in which participants will perform 10 quick contractions in each set, each consisting of a 1-second contraction followed by a 1-second relaxation. Intervention 2: Group 2 (Reflexology): Participants in this group will be taught reflexology techniques by the researcher, who has completed the required training sessions and obtained a reflexology training certificate from a physiotherapy specialist. The reflexology intervention will be performed by the researcher during the first session, during which the participant will be thoroughly instructed on the correct technique and reflex points. In the second session, participants will be asked to perform the technique themselves under the researcher’s supervision to ensure accuracy and proper execution. After completing these initial sessions, participants will continue the remaining reflexology sessions as self-administered practice at home. To help participants remember the correct techniques and reflex points, they will be asked to record a short video of the first session while the researcher demonstrates and explains the correct reflexology method. This video can later be used as a reference if participants forget any part of the procedure. Reflexology will be conducted in a quiet, private room with the participant lying on a couch or examination bed. The room temperature will be adjusted to ensure the participant feels comfortable, without experiencing cold or sweating. Each participant’s feet will first be cleaned with a warm, damp cotton towel. The reflexology protocol will begin with the right foot. Relaxation techniques such as ankle rotations and gentle vibrations will be applied, followed by general massage of the entire sole of the foot for five minutes. Reflexology massage will then be performed by applying rhythmic, alternating pressure with the thumb on specific reflex points corresponding to the pituitary gland, kidneys, ureters, bladder, vagina, and pelvic region. Pressure will be applied for one minute on each point, strong enough to cause whitening of the nail bed but without causing pain. The session will conclude with compression of the solar plexus and relaxation maneuvers. The same procedure will then be performed on the left foot. Immediately after each reflexology session, participants will be advised to drink one glass (200 mL) of water to help eliminate metabolic waste products. Each reflexology session will last approximately 20 minutes (10 minutes per foot). Participants in the reflexology group will perform the foot reflexology sessions three times per week for eight week. Intervention 3: Combined Group: Participants in this group will perform PFMT according to the same protocol as the PFMT-only group and will receive reflexology every other day (once per day), immediately after completing the PFMT exercises, for a duration of eight weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is Confidentiality of participant information
public Kosar Abdollahi
Faculty of Nursing and Midwifery, South Shariati Street
Tabriz Iran (Islamic Republic of) 5415933739 009841344753906 kosarabdollahiii1379@gmail.com Tabriz University of Medical Sciences scientific Mahnaz Shahnazi
Faculty of Nursing and Midwifery, South Shariati Street
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3477 2699 mshahnazi@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Literacy in reading and writing at the middle school level. Obtaining a score of 4 or higher from the first three questions of the QUID questionnaire for the diagnosis of urinary incontinence. Having a phone number for follow-up. Organ health in the legs, especially the soles of the feet. no limit 50 years Female Travel during the intervention period or change of residence. Acute or chronic diseases that may affect the study results (such as uncontrolled diabetes, renal failure, or severe motor disorders). Pregnant women or those who have delivered within the past 6 months (due to the effect of hormones and anatomical changes on urinary incontinence). Smoking or alcohol consumption. History of reconstructive surgeries in the genital and urinary system. Having urinary tract infection. Asthma and chronic cough (more than three months). History of abnormality in the genitourinary system. Use of other treatments such as traditional medicine or biofeedback for urinary incontinence. Obtaining a score of 13 or higher from the standard urinary incontinence short form questionnaire (ICIQ-UI SF). Women over 50 years of age. N39.3 Stress incontinence (female) (male) Treatment - Other Treatment - Other Treatment - Other Group 1 (PFMT): Participants assigned to the pelvic floor muscle training (PFMT) group will be instructed to perform the exercises as taught. Before starting the exercises, the bladder should be emptied. The exercises can be performed in different body positions—lying down with legs straight, sitting with the back upright, or standing with feet shoulder-width apart. To identify the muscles involved in urinary control, participants will be asked to try to stop the flow of urine once while urinating by contracting their pelvic floor muscles. This helps them recognize the correct muscles to use, and they will be advised not to repeat this maneuver more than once or twice to avoid the risk of urinary tract infections. During training, breathing should remain normal, and only the pelvic floor muscles should contract while the rest of the body stays relaxed. The PFMT program will be carried out for eight weeks. Each week, the exercises will be performed three times per day (morning, afternoon, and evening) on five to six days per week, allowing one rest day to accommodate individual lifestyles. In each session, three sets will be performed, with 10 to 15 repetitions per set, and each session will last approximately 15–20 minutes. The progression of exercises is structured as follows: during weeks 1 and 2, the focus will be on learning the correct technique, with each contraction held for 3 seconds followed by 3 seconds of rest between contractions, performed in the lying position. During weeks 3 and 4, the duration of contraction and relaxation will increase to 4 seconds each, with 12 repetitions per set, and the sitting position will be added. From weeks 5 to 8, each contraction and relaxation will last 5 seconds, with 15 repetitions per set, and exercises will be performed in three positions: lying, sitting, and standing. In addition to slow contractions, fast contractions will be introduced during the later weeks, in which participants will perform 10 quick contractions in each set, each consisting of a 1-second contraction followed by a 1-second relaxation. Group 2 (Reflexology): Participants in this group will be taught reflexology techniques by the researcher, who has completed the required training sessions and obtained a reflexology training certificate from a physiotherapy specialist. The reflexology intervention will be performed by the researcher during the first session, during which the participant will be thoroughly instructed on the correct technique and reflex points. In the second session, participants will be asked to perform the technique themselves under the researcher’s supervision to ensure accuracy and proper execution. After completing these initial sessions, participants will continue the remaining reflexology sessions as self-administered practice at home. To help participants remember the correct techniques and reflex points, they will be asked to record a short video of the first session while the researcher demonstrates and explains the correct reflexology method. This video can later be used as a reference if participants forget any part of the procedure. Reflexology will be conducted in a quiet, private room with the participant lying on a couch or examination bed. The room temperature will be adjusted to ensure the participant feels comfortable, without experiencing cold or sweating. Each participant’s feet will first be cleaned with a warm, damp cotton towel. The reflexology protocol will begin with the right foot. Relaxation techniques such as ankle rotations and gentle vibrations will be applied, followed by general massage of the entire sole of the foot for five minutes. Reflexology massage will then be performed by applying rhythmic, alternating pressure with the thumb on specific reflex points corresponding to the pituitary gland, kidneys, ureters, bladder, vagina, and pelvic region. Pressure will be applied for one minute on each point, strong enough to cause whitening of the nail bed but without causing pain. The session will conclude with compression of the solar plexus and relaxation maneuvers. The same procedure will then be performed on the left foot. Immediately after each reflexology session, participants will be advised to drink one glass (200 mL) of water to help eliminate metabolic waste products. Each reflexology session will last approximately 20 minutes (10 minutes per foot). Participants in the reflexology group will perform the foot reflexology sessions three times per week for eight week. Combined Group: Participants in this group will perform PFMT according to the same protocol as the PFMT-only group and will receive reflexology every other day (once per day), immediately after completing the PFMT exercises, for a duration of eight weeks. Stress Urinary Incontinence Score. Timepoint: At baseline (before the intervention), and at 4 and 8 weeks after the intervention. Method of measurement: The standardized ICIQ-UI SF questionnaire. "Pelvic Floor Muscle Strength Score". Timepoint: At baseline (before the intervention), and at 4 and 8 weeks after the intervention. Method of measurement: Modified Oxford Scale. "Stress Urinary Incontinence–Related Quality of Life Score". Timepoint: At baseline (before the intervention), and at 4 and 8 weeks after the intervention. Method of measurement: Incontinence Quality of Life questionnaire (I-QoL). "Women's Satisfaction". Timepoint: After completion of the intervention. Method of measurement: satisfaction checklist. Tabriz University of Medical Sciences Approved 2025-09-24 Ethics Committee of Tabriz University of Medical Sciences Reaserch department, third floor, central construction nute 2, Tabriz university of medical sciences, Golgasht street, Azadi avenue Tabriz East Azarbaijan Iran (Islamic Republic of)