Development of an anatomic intravaginal device and comparison with a conventional vaginal cone regarding their effectiveness in pelvic floor muscle perception and strength - randomized clinical test

Castro N1, Ramos J1, Barja P2, Lima F2

Research Type

Clinical

Abstract Category

Health Services Delivery

Abstract 479
Open Discussion ePosters
Scientific Open Discussion Session 30
Saturday 10th September 2022
11:15 - 11:20 (ePoster Station 6)
Exhibition Hall
Clinical Trial New Devices Physiotherapy
1. Instituto Superare, 2. Universidade Vale do Paraíba
In-Person
Presenter
Links

Poster

Abstract

Hypothesis / aims of study
The weakness and lack of perception of the perineal musculature and pelvic floor cause a series of emotional and social problems that can affect the social quality of life. This muscular structure is responsible for maintaining the support of the internal organs and participating in the maintenance of the urinary and fecal continence, as well as allowing coitus and childbirth. The objective of this study was evaluating the maximum pressure during the contraction of the perineal musculature and the performance of the pelvic floor muscles after the using both the anatomical intravaginal device and the conventional vaginal cone.The analysis of the data showed a statistically significant difference, concerning the evaluated parameters, in the group that used the anatomically-shaped intravaginal device. Therefore, the conclusion is that the anatomical intravaginal device, developed in this study, was more effective than the conventional vaginal cone regarding the improvement of the maximum perineal contraction pressure, local perception and muscular performance.
Study design, materials and methods
For this purpose, 30 women were selected and randomly and equally divided in three groups: Group I - Control, Group II - Used the conventional vaginal cone and Group III - Used the anatomically-shaped intravaginal device, developed in order to accomplish the research. The volunteers in groups II and III were respectively submitted to a protocol with the vaginal cone and the intravaginal device and, after the use, they were assessed in order to verify their maximum pressure and the capacity of pelvic floor contraction
Results
After the data analysis, it was verified that the mean obtained by the three contractions performed with a three-second rest between them, captured by the bargraph and biofeedback, followed by the use of the anatomical intravaginal device was significantly greater when compared with the conventional vaginal cone and the control group.
The analysis of the data showed a statistically significant difference, concerning the evaluated parameters, in the group that used the anatomically-shaped intravaginal device.
Interpretation of results
After the collection and organization of the results, the statistical tests were carried out. Initially, the Kolmogorov-Smirnov test was performed in order to verify if the data followed the Gaussian distribution, which was proven true for the two techniques used and for the three experimental groups.
Then, the parametric ANOVA test was performed, obtaining p ≈ 0.001 for each of the evaluation techniques, which corresponds to a highly significant difference. Data analysis revealed a statistically significant difference between the results generated by the use of the new intravaginal device when compared to the conventional vaginal cone.
Concluding message
The intravaginal device developed in this study was more effective in improving the perception and the consequent perineal muscle contraction capacity, in comparison with the conventional cone, which can be assigned to its innovative configuration and design concerning the anatomical shape and increased diameter and length
Figure 1 Bargraph BoxPlot
Figure 2 Biofeedback BoxPlot
Disclosures
Funding Own financing. The development and production of the device in question was offered by the company Plateam Tecnoplástico Clinical Trial Yes Registration Number ORCID ID 0000-0001-6001-9561 RCT Yes Subjects Human Ethics Committee institutional and/or national research committee Helsinki Yes Informed Consent Yes
06/10/2024 04:47:42