Introduction
Urinary incontinence is a common problem faced, especially among women and the elderly population. Exercises to strengthen the muscles of the pelvic floor are the first-line care that is most recommended. However, most people find it challenging to adhere to the exercise routine and patterns. This led to the advent of new strategies to solve this issue. A digital therapeutic device for urinary incontinence is yet an innovative approach. This article measures the success of such devices in managing urinary incontinence.
What Is Urinary Incontinence?
An inability to hold the urge to pass urine is termed urinary incontinence. It is a common condition seen in women, especially in those following childbirth. It can have a toil on their life as a whole, from mental health to sexuality, social, and work life. It can also have an impact on their productivity and socio-economic life.
Strengthening of the muscles in the pelvic floor is the main solution for this issue. Patient education and lifestyle modifications can be other options that can be beneficial. Time constraints and geographical distance can be challenges that most people face, in addition to the scarcity of trained healthcare professionals who can supervise and guide patients in core strengthening exercises. Unsupervised home therapy has often been seen to be an ineffective therapy due to poor adherence and improper knowledge of the technique. This led to research on digital devices that can be beneficial.
What Are Digital Therapeutic Devices?
Digital therapeutic devices are emerging branches of medical science. In digital therapeutics (DTx), software is used to improve the functioning of health, prevent diseases, or treat or manage an existing condition. It can be prescribed or non-prescribed.
Products, devices, internet applications, or other technologies that are used for the prevention, treatment, or management of medical conditions, disorders, or diseases require a formal prescription from a qualified healthcare professional and are regulated by the US Food and Drug Administration (FDA) is called a prescription digital therapeutics (pDTx). Patient privacy and security, and published, peer-reviewed for clinically meaningful outcomes are other criteria that are fundamental in describing a good or successful digital therapeutic device. The creation of real-world evidence (RWE) is made possible by the assessment of real-world data (RWD) produced by the usage of prescription digital therapeutics (pDTx) beyond clinical trials is one more criterion and new possibility offered.
The effectiveness of a digital therapeutic device is the way that an intervention works in the real world. On the other hand, efficacy is the extent to which a treatment or intervention fulfills its expected goal under ideal and controlled circumstances as obtained from random clinical trials. Treatments involving behavioral interventions (treatments that require the patient to take some steps to improve the condition, like pelvic floor exercises in urinary incontinence) use the contrast between efficacy and efficiency.
How Is Digital Therapeutics Different From Digital Health?
There are a number of differences between digital therapeutics and digital health. Digital health does not have support from evidence from any clinical trials. It does not have a structured treatment protocol, or, is a prescription-grade therapeutic. On the other hand, digital therapeutics is a game-changer in many chronic conditions, lending a hand in behavior modification, and effective therapeutic results when used in combination with a pharmaceutical or surgical intervention. It is based on the outcomes of many random clinical trials. Being non-invasive and less complicated, it helps the patient to be involved in the treatment process more.
What Are the Digital Therapeutic Devices Available for Urinary Incontinence?
The first device that offers digital therapeutic therapy for pelvic floor muscle training in order to improve the symptoms of urinary incontinence is a prescription device with a vaginal insert. It helped to achieve greater improvement in managing urinary incontinence than the traditional pelvic floor exercises, according to a study done by Obstetrics and Gynecology journal.
Biofeedback devices use information based on the pressure readings in the vagina. On the other hand, this device uses the accelerometer (a device that measures the vibration or changes in motion of a structure) to provide visual information about muscle elevation. This highlights the importance of how pelvic floor muscle contraction works. It also helps the woman to track her progress including monthly reports. The device provides a guided option for training the pelvic floor muscles at home within five minutes. It has been proven to be an effective device, that is easy to use. It received approval from the FDA in 2014. Recently, it was modified for fecal incontinence. The device for fecal incontinence received approval in July 2022.
However, it requires knowledge and expertise to use a smartphone. In addition, the patient requires to insert the device into the vagina for the exercise. So those who feel embarrassed or uncomfortable may not find the device appropriate. It can not be used in people other than those who are women assigned at birth and have vaginas. In addition, it might not be covered in all insurance policies, as it still requires further research.
The device consists of a small FDA-cleared vaginal wand that is connected to a smartphone. It provides clear movement of the pelvic muscles in real-time, thereby enabling the woman to monitor her progress according to muscle movements. In addition, it enables the involvement of a healthcare professional if required and guides the woman in the pelvic muscle movements. This increases the effectiveness of the treatment process. The device is available with a prescription from a healthcare professional. This also enables the healthcare professional to be actively involved in the treatment and progress of the therapy.
Conclusion
Urinary incontinence is a common issue, mainly among women. Exercises to strengthen the pelvic floor muscles have been the first-line treatment for this. However, it has been seen to be less effective due to improper techniques and low patient adherence. Digital therapeutics play an effective role in terms of outcomes, cost, and access. Studies show that these devices have been effective in treating the conditions or disorders they have been designed for. It has proven to yield desired results when used as a standalone mode or in combination with medication or a medication. However, more research is needed to conclude its efficiency and effectiveness.
