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IRCT20250417065362N1 IRCT 2025-08-20 Rafsanjan University of Medical Sciences Effect of pelvic floor muscle exercise and acupressure on urinary incontinence in women with multiple sclerosis Comparison the effect of pelvic floor muscle exercise and acupressure on urinary incontinence in women with multiple sclerosis 2025-09-01 anticipated 96 Complete https://irct.ir/trial/83049 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: After obtaining the necessary permits, the researchers will first select 96 women (32 in each group) from among the total number of women with multiple sclerosis who have a file at the Center for Special Diseases of Ali Ibn Abi Taleb Hospital in Rafsanjan, using a purposive sampling method based on the inclusion criteria. Eligible participants will then be assigned to groups using the minimization randomization method, according to the levels of incontinence severity. The pre-test will be conducted at four levels: mild (score 1–5), moderate (score 6–12), severe (score 13–18), and very severe (score 19–21), across three groups: intervention with Kegel exercises, intervention with acupressure, and a control group. The first participant at each severity level will be assigned to one of the study groups by random drawing through a sealed envelope. The next participant with the same severity of incontinence will be randomly assigned to one of the two remaining groups. The third participant with the same severity will be assigned to the last group. This process will continue until the desired sample size is achieved, Blinding description: Participants will not be informed that the interventions are specifically intended to affect urinary incontinence. The evaluator will remain unaware of the intervention assigned to each participant when completing the questionnaires. To ensure blinding of the data analyst, the study groups will be identified by the letters A, B, and C rather than by the intervention names. N/A Multiple sclerosis. Intervention 1: First intervention group: In addition to their prescribed medications, participants in this group will perform daily pelvic floor muscle exercises for eight weeks. The exercises will be carried out three times per day (9:00 am, 3:00 pm, and 9:00 pm) in three sets, with each set consisting of 10 repetitions. During each repetition, participants will be instructed to contract their pelvic floor muscles for 6 seconds (contraction phase), followed by a 6-second relaxation phase. To facilitate correct identification and contraction of the pelvic floor muscles, participants will be guided to imagine attempting to prevent the passage of intestinal gas by tightening the ring of muscles around the anus, while avoiding contraction of the leg or buttock muscles. The correct contraction should produce a sensation of the vagina and rectum being pulled upward and inward. Intervention 2: Second intervention group (Acupressure): In addition to their usual treatments, participants in this group will receive acupressure at the K3 point (located midway between the inner ankle and the Achilles tendon). Acupressure will be self-administered constantly and continuously using the thumb or another finger, three times per week (Saturday, Monday, and Wednesday) at 9:00 am, for a total duration of eight weeks. Each session will last 30 minutes (15 minutes per leg), consisting of 1–2 minutes of constant pressure followed by a 10–15 second rest, repeated throughout the session. To support adherence and ensure regular practice on the specified days, participants will be provided with a timetable to record each completed session. Prior to the start of the intervention and throughout the study, participants will receive detailed guidance from the researcher on the correct method and underlying mechanism of the intervention. This training will be delivered through in-person sessions at the MS department, as well as via telephone, and by sending instructional photos or videos through the EITA software. Intervention 3: Control group: Will not receive any intervention other than routine treatments. 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 further information.
public Fatemeh Akbarzadeh Fathabadi
Abuzar Alley 17, left side of the sixth door، Abuzar Street
Zarand Iran (Islamic Republic of) 7761753796 +98 34 3342 9886 ftmeakbarzade@gmail.com Rafsanjan University of Medical Sciences scientific Fatemeh Akbarzadeh Fathabadi
Abuzar Alley 17, left side of the sixth door، Abuzar Street
Zarand Iran (Islamic Republic of) 7761753796 +98 34 3342 9886 ftmeakbarzade@gmail.com Rafsanjan University of Medical Sciences Iran (Islamic Republic of) Age 18 to 65 years Having the physical and cognitive ability to learn and perform interventions At least one month has passed since starting or changing effective medications for urinary incontinence (such as oxybutynin, tolterodine, and solifenacin) 18 years 65 years Female Simultaneous use of common complementary therapies such as yoga, psychotherapy, Pilates, meditation Pregnancy Being in the acute or recurrent stage of the disease Urinary tract infection Having other chronic and acute physical and mental illnesses according to medical records Being within 6 months after natural childbirth Having a history of third- or fourth-degree lacerations during vaginal delivery G35 Multiple sclerosis Rehabilitation Rehabilitation N/A First intervention group: In addition to their prescribed medications, participants in this group will perform daily pelvic floor muscle exercises for eight weeks. The exercises will be carried out three times per day (9:00 am, 3:00 pm, and 9:00 pm) in three sets, with each set consisting of 10 repetitions. During each repetition, participants will be instructed to contract their pelvic floor muscles for 6 seconds (contraction phase), followed by a 6-second relaxation phase. To facilitate correct identification and contraction of the pelvic floor muscles, participants will be guided to imagine attempting to prevent the passage of intestinal gas by tightening the ring of muscles around the anus, while avoiding contraction of the leg or buttock muscles. The correct contraction should produce a sensation of the vagina and rectum being pulled upward and inward. Second intervention group (Acupressure): In addition to their usual treatments, participants in this group will receive acupressure at the K3 point (located midway between the inner ankle and the Achilles tendon). Acupressure will be self-administered constantly and continuously using the thumb or another finger, three times per week (Saturday, Monday, and Wednesday) at 9:00 am, for a total duration of eight weeks. Each session will last 30 minutes (15 minutes per leg), consisting of 1–2 minutes of constant pressure followed by a 10–15 second rest, repeated throughout the session. To support adherence and ensure regular practice on the specified days, participants will be provided with a timetable to record each completed session. Prior to the start of the intervention and throughout the study, participants will receive detailed guidance from the researcher on the correct method and underlying mechanism of the intervention. This training will be delivered through in-person sessions at the MS department, as well as via telephone, and by sending instructional photos or videos through the EITA software. Control group: Will not receive any intervention other than routine treatments. Urinary incontinence severity based on the score obtained from the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form/ICIQ-UI SF. Timepoint: Before, 4 and 8 weeks after the start of the intervention. Method of measurement: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form/ICIQ-UI SF. Rafsanjan University of Medical Sciences Approved 2025-05-27 Ethics Committee of Rafsanjan University of Medical Sciences Faculty of Nursing and Midwifery, Parastar Street, Jomhori-e-Eslami Boulevard Rafsanjan Kerman Iran (Islamic Republic of)