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IRCT20160601028203N3 IRCT 2023-04-05 Shahid Beheshti University of Medical Sciences Effects of Pelvic Floor Muscle Training The effects of Pelvic Floor Muscle Training in diabetic pregnant women with urinary incontinence 2023-04-21 anticipated 40 Complete https://irct.ir/trial/69285 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The creation of randomization sequence will be limited block randomization with random block size (block size: 2, 4, 6). In this way, the study participants are randomly placed in one of the two control or treatment groups. Web-based randomization method (www.sealedenvelope.com) is used to generate random sequence. Opaque sealed envelopes with a random sequence will be used to conceal the random allocation. This work is done with the help of a person who has no role in the research process. Based on the order of entry of eligible participants into the study, which are selected by the gynecologist, one of the envelopes will be opened and the group assigned to that participant will be determined, Blinding description: The evaluator will not know about the allocation of grouping of people participating in this study. Only the participants and the physiotherapist involved in training the exercises will know about the assignment of the groups. N/A Urinary incontinence. Intervention 1: Intervention group: The protocol consisted of pelvic floor muscle strengthening exercises. Women were encouraged to perform three sets of ten slow contractions, holding each contraction for 6 to 8 seconds, followed by a rest period equal to the duration of the contraction. and finally three to four rapid contractions are performed in supine, sitting and standing positions for at least three times a day. Mothers do these exercises for 10 consecutive weeks (25 weeks of pregnancy to 35 weeks of pregnancy) and gradually the number of contractions increases. In each exercise, pay attention that the muscles of the pelvic floor are contracted and the muscles of other parts of the pelvis are relaxed. During the research, the examiner communicates with the mother two days a week through social networks and phone calls. Intervention 2: Control group: This group will be given the usual recommendations for care during this period and pelvic floor strengthening exercises in the form of pamphlets. Yes - There is a plan to make this available What will be shared: Information about outcomes can be shared. When: one week To whom: All researchers and students can access these data. Conditions: All researchers and students can access these data. Where to obtain: Applicants can send their request to ghadiri.pt93@gmail.com to receive documents or data. How to obtain: Documents and data files can be accessed at the request of the applicant via email to ghadiri.pt93@gmaail.com Comments:
public Parisa Ghadiri Harati
Shahid Sadoughi Hospital, Sayad Shirazi St., Shahid Ghandi Blvd., Safaieh
Yazd Iran (Islamic Republic of) 8915887856 +98 35 3822 4000 ghadiri.pt93@gmail.com Shahid Beheshti University of Medical Sciences scientific Parisa Ghadiri Harati
Shahid Sadoughi Hospital, Sayad Shirazi St., Shahid Ghandi Blvd., Safaieh
Yazd Iran (Islamic Republic of) 8915887856 +98 35 3822 4000 ghadiri.pt93@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) First pregnancy Gestational age of 25 week Presence of urinary incontinence Gestational diabetes mellitus 20 years 30 years Female High risk pregnancy Presence of other neuromuscular disease Use of other treatment for urinary inontinence Twin pregnancy N39.3 Stress incontinence (female) (male) Rehabilitation Rehabilitation Intervention group: The protocol consisted of pelvic floor muscle strengthening exercises. Women were encouraged to perform three sets of ten slow contractions, holding each contraction for 6 to 8 seconds, followed by a rest period equal to the duration of the contraction. and finally three to four rapid contractions are performed in supine, sitting and standing positions for at least three times a day. Mothers do these exercises for 10 consecutive weeks (25 weeks of pregnancy to 35 weeks of pregnancy) and gradually the number of contractions increases. In each exercise, pay attention that the muscles of the pelvic floor are contracted and the muscles of other parts of the pelvis are relaxed. During the research, the examiner communicates with the mother two days a week through social networks and phone calls. Control group: This group will be given the usual recommendations for care during this period and pelvic floor strengthening exercises in the form of pamphlets. Comparison of bladder base displacement with ultrasound to evaluate the strength of the pelvic floor muscles. Timepoint: Measuring of bladder base displacement at the beginning of the third trimester (28-25 weeks), late third trimester (35-32 weeks). Method of measurement: Measurement of bladder base displacement by ultrasound. Measurement of quality of life. Timepoint: Early third trimester (25-28 weeks), late third trimester (35-32 weeks). Method of measurement: Measurement of quality of life with incontinence quality of life (I-QOL) questionnaire. Shahid Beheshti University of Medical Sciences Approved 2021-11-28 Research Ethics Committees of Vice-Chancellor in Research Affairs - Shahid Beheshti University of Me Physiotherapy department, Rehabilitation school of Shahid Beheshti University of Medical Sciences, Damavand Ave, Tehran Tehran Tehran Iran (Islamic Republic of)