Intravaginal device of direct assessment of the strength of the pelvic floor muscles and others parameters

• Grant number: 17/00852-8
• Support Opportunities: Research Grants - Innovative Research in Small Business - PIPE
• Duration: December 01, 2017 - September 30, 2018
• Field of knowledge: Engineering - Biomedical Engineering - Medical Engineering
• Principal Investigator: Daiana Laurenci Orth
• Grantee: Daiana Laurenci Orth
• Host Company: Bio Star Tech Desenvolvimento Ltda. - ME
• City: Sorocaba
• Associated researchers: Fernando Manuel Araújo Moreira ; Patricia Driusso ; Vanessa de Oliveira Sousa ; Vilena Barros de Figueiredo
• Associated scholarship(s): 18/01385-7 - Intravaginal device of direct assessment of the strength of the pelvic floor muscles and others parameters, BP.PIPE

Abstract

Pelvic floor muscles (PFM) form a supporting mechanism of the pelvic organs and are fundamental for fecal and urinary continence. The function of the bladder, bladder neck and urethra depends on the integrity of the nerve and support structures (tendon arch, anus lift and endopelvic fascia). This interaction allows the mechanism of urethral closure, effectiveness in the transmission of forces to the urethra, bladder neck and reflex activation of the PFM when the intra abdominal pressure increases. Thus, anatomic dysfunctions in these supporting structures may contribute to the occurrence of urinary incontinence (UI). The UI affects approximately 50% of women worldwide, which is defined by the International Continence Society as the complaint of any involuntary loss of urine. Arnold Kegel in 1948, emphasized the importance of MAP training, he had already stated that even the woman who underwent surgical treatment should perform the training of the MAP to restore the function of this musculature. He used a perineal manometer, made by himself, which was called perineometer, to indirectly evaluate the strength of this muscle. Over the years, PFM assessment techniques have been developed to monitor the treatment and to better understand the physiology of this musculature, as well as to help women become aware of it. Digital palpation is widely used by its low cost and is based on scales to classify the contraction force of the PFMs on the finger of the evaluator, however it is a subjective evaluation and depends on the evaluator's experience. The perineometer is an equipment widely used worldwide, but it measures only the indirect force of contraction of the PFM. Dynamometers are devices that perform the direct evaluation of the strength of the PFM, for this reason, research groups from different countries have developed their own equipment. A search of vaginal dynamometers was carried out in the national and foreign market and only one manufacturer of this equipment was found in the national market. In view of the need for equipment to perform a direct evaluation of the strength of the PFM, our group made a critical analysis of the equipment found in the literature, commercially available and patent records, and from that analysis a utility model was proposed (process number BR 10 2016 026365 4) that contains important characteristics of these equipments and that intends to solve some limitations that can interfere in the functional evaluation of this musculature. The proposed utility model has three configurations and the purpose of this research proposal is to verify the economic and technological viability of the proposed configurations. It is hoped at the end of this project to verify for each one its cost-benefit ratio that will best enable the development of a technological innovation in order to make one, or more, equipment commercially available to physiotherapists, professionals who perform the evaluation and training of this musculature. Still, it is expected that with the equipment present in the market, it will be possible to stimulate the conservative treatment of UI, reducing the risks to women undergoing surgeries, besides stimulating a continuous evaluation of this muscle for the early detection of PFM dysfunctions. It will be an equipment that will allow an objective evaluation of this musculature, providing greater safety to the professional that uses it and will provide important parameters, especially the direct evaluation of the strength of the pelvic floor muscles. (AU)