As stated by the International Continence Society , urinary incontinence (UI) is defined as any leak or involuntary loss of urine that implies a social and hygienic problem. UI affects both sexes, however, women are more affected than men. The conservative approach is considered the first choice of treatment due to its accessibility, cost-effectiveness, and limited risks and side effects compared to more invasive treatments. Conservative management consists of lifestyle changes and exercises that strengthen the pelvic floor muscles (PFM). Supervised pelvic PFMT’ refers to a course of treatment that involves one-to-one supervision by a health-care professional (usually a physiotherapist or nurse) to ensure that the woman can correctly contract her pelvic floor muscles, and provides ongoing teaching, guidance and motivation relating to pelvic floor muscle exercises (PFMEs). Adjuncts used with supervised PFMT in clinical practice include vaginal cones, electrical stimulation and biofeedback. Biofeedback is the technique by which information about a normally unconscious physiological process is presented to the patient and/or the therapist as a visual, auditory or tactile signal

This study aimed to validate the performance of a portable biofeedback device Conti4All, for assessing pelvic floor muscle (PFM) contraction by comparing its output with concomitant transabdominal ultrasound (TAUS) imaging. Specifically, the study evaluated whether contractions recorded by the device correspond to objectively verified PFM activity visualized on the TAUS during the same contraction in women.

This study employed a descriptive correlational design to evaluate the relationship between pelvic floor muscle (PFM) contractions recorded using the Conti4All device and those visualized via transabdominal ultrasound (TAUS). 
A total of 51 female volunteers aged between 18 and 60 years were recruited for the study. Participants included both nulliparous and multiparous women who were asymptomatic and had no prior experience with pelvic floor muscle training. All participants reported no symptoms of urinary incontinence at the time of enrollment. 
Exclusion criteria included pregnancy, age outside the defined range, and any known neurological or other medical conditions that could affect pelvic floor function.
Participants were instructed to drink 500ml of water prior to examination, to ensure adequate visualization of the bladder base displacement during contraction of the PFM. Each participant was instructed to perform a series of guided pelvic floor muscle contractions following standardized instructions provided through the Conti4All system. During each contraction, real-time ultrasound imaging was performed to visualize pelvic floor activity.

Data regarding the age, parity, type of delivery and presence of concomitant diseases are presented in Table 1. A significant positive correlation was observed between the biofeedback signals obtained from the Conti4All device and ultrasound-confirmed pelvic floor muscle contractions. These findings support the validity of the device as a reliable tool for detecting PFM activity.

All participants reported high levels of satisfaction with the procedure, describing it as quick, non-invasive, and comfortable. Additionally, participants perceived the device as a useful tool for guiding and improving pelvic floor muscle training.

Overall, the Conti4All device demonstrates strong potential as an accessible and user-friendly solution for objective assessment and biofeedback-based training of pelvic floor muscle function.

Effectiveness of Pelvic Floor Muscle Training on Quality of Life in Women with Urinary Incontinence: A Systematic Review and Meta-Analysis César Adrián Curillo-Aguirre 1, Enrique Gea-Izquierdo 1,* Medicina logo Medicina (Kaunas) . 2023 May 23;59(6):1004. doi: 10.3390/medicina59061004
Reliability and validity of pelvic floor muscle displacement measurements during voluntary contractions Helene Moser  1   2 , Helena Luginbuehl  3 , Jean-Pierre Baeyens  4 , Lorenz Radlinger  3Observational Study Int Urogynecol J  . 2019 Dec;30(12):2093-2100. doi: 10.1007/s00192-019-03932-x.
Reliability of Pelvic Floor Muscle Assessment with Transabdominal Ultrasound in Young Nulliparous Women Bartosz Zajac  1 , Iwona Sulowska-Daszyk  2 , Anna Mika  2 , Artur Stolarczyk  3 , Ewelina Rosloniec  2 , Aleksandra Królikowska  4 , Marian Rzepko  5 , Lukasz Oleksy  3    J Clin Med  . 2021 Aug 3;10(15):3449. doi: 10.3390/jcm10153449.