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Effectiveness of the pelvic floor muscle training in aquatic ambient on pelvic floor muscle function and pregnancy specific urinary incontinence in pregnant women with Gestational Diabetes Mellitus: a feasibility study to randomized controlled trial

Grant number: 21/10665-6
Support type:Scholarships in Brazil - Post-Doctorate
Effective date (Start): November 01, 2021
Effective date (End): October 31, 2022
Field of knowledge:Health Sciences - Physiotherapy and Occupational Therapy
Principal researcher:Angélica Mércia Pascon Barbosa
Grantee:Caroline Baldini Prudencio
Home Institution: Faculdade de Medicina (FMB). Universidade Estadual Paulista (UNESP). Campus de Botucatu. Botucatu , SP, Brazil
Associated research grant:16/01743-5 - The new gestational triad: hyperglycemia, urinary incontinence (UI) and biomolecular profile as a long-term predictor for UI: a prospective cohort study: translational research with biodevice with stem cells for muscle regeneration in diabetic rats, AP.TEM

Abstract

Experimental studies of the urethral muscles of pregnant diabetic rats detected atrophy, thinning, disorganization and tearing associated with loss of normal anatomical location and alteration in the proportion of fast and slow fibers. It was later determined that animal-like deterioration occurs in pregnant women and thus characterized as gestational diabetic myopathy. In parallel, cohort study identified that the PFM functionality of pregnant women with gestational diabetes (GDM) is altered compared to non-GDM pregnant women during pregnancy and postpartum. Preventive actions and treatment for urinary incontinence are urgent, especially in this group with additional risk related to myopathy. The current thematic proposal develops two strands of pre-clinical proposals, namely the mesenchymal stem cell latex biodevice and the experimental protocol of exercise in an aquatic environment in pregnant animals. The results from the preclinical exercise-related protocol are quite promising, it was identified that exercise is able to attenuate myopathic changes and ECM composition. Clinically there is evidence A indicating the supervised training for MAP for the treatment of urinary incontinence as first-line treatment in women with UI during pregnancy of women at usual risk. However, there is no clarity in the literature regarding its effects on special groups such as pregnant women with GDM. Methods: Prepare the feasibility study protocol following the standard guidelines items, which are: Statement of recommendations for intervention trials (Recommendations for Interventional Trials statement ) and the template for the description of the intervention and replication checklist ( the template for intervention description and replication ) ( TIDieR ). When reporting the feasibility study, we will follow the statement of the Consolidated Standards of Reporting Trials for non- pharmacological treatment ( Consolidated Standards of Reporting Trials statement for non- pharmacological treatment ). The RCT protocol that will be tested for feasibility of implementation will be composed of 3 therapeutic groups: Group 1) Hydrotherapy associated with pelvic floor training; 2) Hydrotherapy 3) Ground pelvic floor training. The groups will be shaped in this way to check the possibility of additional therapeutic effect. This study have no intention to assess the effectiveness of the experimental intervention, so 15 participants will be included considering participation in the 3 planned moments. One of the objectives of the scholarship is to verify the sample calculation necessary to conduct the final ECR. The " time points " tested will be 24-30 gestational weeks (baseline) and 36-38 gestational weeks. The tested protocol will consist of the following sequence: 1) Recruitment : Participants will be recruited through basic health units, hospitals, advertisements in newspapers and social networks. 2) Randomization : Participants will be individually randomly allocated (1:3 ratio) into one of the intervention groups. The block randomization schedule will be generated online via software. 3) Outcomes : It is important to emphasize that due to the nature of this proposal being a feasibility study, the secondary outcomes of this proposal will become the primary and secondary outcomes in the final randomized clinical trial that will be proposed based on the results found in this study. So at this point the main outcome will be a ) recruitment rate, b) ratio participants included participants and tracked, c) adherence to the protocol d) abandonment rate / withdrawal. Secondary outcomes: severity of urinary incontinence (ISI, ICIQ-SF and pad test), pelvic floor function (digital palpation - Perfect , ultrasonography), global scale of perception of improvement and adverse reaction. (AU)

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