eHealth innovative diagnostics and therapeutical solution for Female Pelvic Floor and Stress Continence

Gervasoni F1, Ricci V1, Boni A2, Andreoli A1, Yokoi Y3, Sekiguchi Y3, Nakamura R3, Sasaoka A3, Fassina C4, Mingardo V4, Trevisan T4, Yoneyama M5, Ogura D6, Summerville M7, Meyer S7, Wu F8, Durai P8, van Zanten J9, Tutelaers M9, Matthijsse D9, Swinckels P9, Ho Yee T8, Pop V9

Research Type

Clinical

Abstract Category

E-Health

Abstract 151
On Demand E-Health
Scientific Open Discussion Session 16
On-Demand
Pelvic Floor Quality of Life (QoL) Stress Urinary Incontinence
1. Unit of Rehabilitation, Luigi Sacco Hospital, ASST Fatebenefratelli Sacco, Milan, Italy, 2. Perugia University Hospital, Interdivisional Urologic clinic: Perugia-Terni, Umbria, Italy, 3. Women’s Clinic LUNA Next Stage, Kanagawa, Japan, 4. I.A.C.E.R., Martellago, Venice, Italy, 5. LifeSense Group Japan, Tokyo, Japan, 6. CBC Co., Ltd, Tokyo, Japan, 7. BioLife, Sydney, Australia, 8. National University Health System, Department of Urology, Singapore, 9. LifeSense Group, The Netherlands
Presenter
F

Fabrizio Gervasoni

Links

Abstract

Hypothesis / aims of study
This abstract provides an overview result of pilot studies performed on 115 women aged 25-70 years old suffering from urinary stress incontinence. The average age of participants being 39.09 years old, and the average weight 77.15kg. During these pilot studies, we used Carin: an innovative non-invasive eHealth solution composed of the Carin sensor and the Carin Pelvic Floor Trainer application. We focused on measurement data collected during an 8-week training period. During the Carin pilot studies, 72% of women fully recovered, and 28% saw over 50% improvement. Based on data collected from 65.2% of the participants (n=75), we hypothesize that the positive results of stress incontinence symptoms are directly correlated to the pelvic floor training frequency women implemented into their daily life, as recommended by Carin. 

Urinary Incontinence (UI) implies the inability to retain urine, creating a bothersome condition experienced by women. Influenced by age and condition its prevalence ranges from 8.5% and 38% (1,2,3). The majority of these women experienced stress UI. Intitially their condition was treated using a conservative therapy approach, and thereafter followed up with surgery (3). Despite the widespread negative impactive of this problem on women’s daily life, there have been few technological advances in eHealth diagnosis and treatment of this condition. 

When looking at the body, the continence control system can be divided into two main parts: the urethral support system and the sphincteric closure system. Beyond the sphincters' activity, continence is impacted by factors such as the tension flexibility in the urethra, the Pelvic Floor Muscles (PFMs) and the watertight seal of soft tissues within the urethral support system. This consists of all the extrinsic structures that provide a supportive layer upon which the urethra rests. In particular, The PFMs are made up of Type 1 (slow-twitch) and Type 2 (fast-twitch) fibres. Understanding the correlation between the pelvic floor Type 1, Type 2 fibres, and the severity of urine leaks or patient activity can help identify specific issues, thereby allowing for a higher quality personalised training for the incontinent patient.
Study design, materials and methods
For the data collected by the Carin solution, we focused on 8-week measurements. The Carin sensor measures real-time, real-life urine leaks, leak severity, leak time and patient activity during the leak. The Carin Pelvic Floor Trainer application is used to store data, recommend personalized training and indicate progress. 
Data from 115 patients treated for urinary incontinence from mild or moderate stress urinary incontinence and able to correctly use the Pelvic Floor Training application were included in this study. Excluding criteria included: previous surgeries for urinary incontinence, other forms of rehabilitative treatment for incontinence, patients with oncological conditions, recurrent urinary infections, congenital urinary tract disorders, psychiatric disorders, inability to issue valid consent, urge-predominant incontinence, pregnancy or breastfeeding. After consent, and before beginning with monitoring via the sensor and the exercises proposed by the application, the majority of the patients were provided with an evaluation by the outpatient folder of Pelvic Floor Rehabilitation (i.e. ICIQ questionnaire, VAS, King's Health Questionnaire – KHQ –, PC test, functional diary, anamnestic data such as the number of tampons used in the course of a day). Patients were then asked to schedule a weekly measurement day, wearing the sensor for 24 consecutive hours.
The sensor then measured the participants' bodily movements and urinary leaks throughout the day, and all the data was collected within the application. Women were then required to perform daily exercises proposed by the pelvic floor trainer (10 minutes a day), repeating the measurement for a whole day during the following week. All this was to be repeated for 8 weeks, to monitor any improvements (in terms of reducing losses), resulting from the strengthening exercises of the pelvic floor muscles.
Results
Results (overview in Figure 1) demonstrates an example of patient progress during the Carin training within the app. The Carin sensor measures in real-time, real-life urine leaks, leak severity, leak time and patient activity during the leak.

Week 1 (day 1 of the measurement): Initially, low patient activities trigger urine loss. Therefore the app recommends training for the Type 1 fibre.

Week 3 (day 3 of the measurement): During this period, a high patient activity triggers urine loss. Based on this, the training adapts and recommends exercises strengthening the Type 2 fast fibres.
Week 5 (day 5 of the measurement): By this point, the app is detecting fewer leakages, but they are a combination of Type 1 and 2 fibres. Therefore, the application recommends a combination of exercises for both Type 1 and 2 fibres. Alongside the application recommends this patient to drink less coffee and carbonated drinks to achieve a possible decrease in urine loss.
Interpretation of results
By doing 10 minutes of exercise per day, patients recovered from their urinary stress incontinence condition. We measured recovery already within the first 3 – 6 weeks with the majority of the patients. The recovery is age-dependent: patients aged between 25 and 50 recover faster than older age patients. Overall, 72% of women were cured (defined by measuring the women’s urine loss) using Carin, and 28% of women saw over a 50% improvement in their condition. For 65.2% of the participants, we monitored the exercise frequency, and 72% of the women exercised daily whilst 28% of the women exercised every four days (Figure 2). Overall, high correlations were found between the frequency of exercise and the desired positive results.
Concluding message
The Carin solution is an efficient eHealth solution to help health practitioners evaluate specific stress urinary incontinence symptoms during trigger activities. However, when using this solution, it is essential for practitioners to monitor the activity data and either follow the personalized training program within the app or suggest a personalized training program for the patient, adapted to the Type I fibres, Type II fibres, physical ability, leakage, pelvic floor knowledge, timeframe and progress.
Figure 1 An example of patient progress and drink, urine leakage and activity data during the Carin training within the app.
Figure 2 Pilot study results (left) and exercise frequency (right) for 65.2% (n=75) of the participants.
References
  1. Herzog AR, Diokno AC, Brown MB, Normolle DP, Brock BM. Two-year incidence, remission, and change patterns of urinary incontinence in noninstitutionalized older adults. J Gerontol 1990;45:M67– 74. [PubMed: 2313045]
  2. Thomas TM, Plymat KR, Blannin J, Meade TW. Prevalence of urinary incontinence. Br Med J 1980;281:143–5
  3. Ashton-Miller JA, Howard D, DeLancey JOL. The Functional Anatomy of the Female Pelvic Floor and Stress Continence Control System. Scand J Urol Nephrol Suppl. 2001 ; (207): 1–125
Disclosures
Funding Nil Clinical Trial No Subjects Human Ethics Committee NHG (National Healthcare Group) DSRB (Domain Specific Review Board) and The 7th Ethics Committee of Medical Corporation LEADING GIRLS Women's Clinic LUNA group Japan Helsinki Yes Informed Consent Yes
17/04/2024 14:09:51