Around the Globe
igital Therapeutics or DTx, defined as “software as medical device” by the FDA and International Medical Device Regulators Forum (IMDRF), continue to gain traction. According to the Digital Therapeutics Alliance, a non-profit trade association based in the US, Digital therapeutics (DTx) delivers evidence-based therapeutic interventions to patients, driven by high quality software programs to prevent, manage, or treat a broad spectrum of physical, mental, and behavioral conditions.
DTx differs from digital health in a number of aspects. Digital health is not supported by clinical evidence derived from a clinical trial, for example. It is not backed by a structured treatment protocol and is not a prescription grade therapeutic. DTx is viewed by industry experts as a game changer for management of chronic conditions, to support behavior modification, and to effect superior therapeutic outcomes in combination with a pharmaceutical or surgical intervention.
There are several examples already on the market. One therapeutic maps location data every time an asthmatic patient uses their inhaler to help prevent future episodes in that location. App-based cognitive behavior training to help patients with opioid deaddiction when used in combination with opioid receptor blocking medication has demonstrated superior outcomes. Another uses video game technology to help patients address attention-related cognitive dysfunction in a variety of conditions. These pioneering apps and video games have already been approved by FDA to be prescribed as a DTx by physicians.
Due to its non-invasive characteristic, and availability in consumer devices, DTx has helped involve the patient in the treatment process to a greater extent than ever before. That bodes well for healthcare in general while making DTx a viable tool in the tool kit of physicians. Applying these and other emerging 21st-century technologies is already altering therapeutic access, consumption, and outcomes in profound ways not thought possible even a decade ago.
DTx in India
Incontinence and Pelvic Pain in India
Various aspects of Indian culture keep incontinence and pelvic pain as taboo topics, especially among women, in India. Many women, fearing the cultural stigma associated with this condition, hesitate to discuss this with their spouse and seek medical attention. The downstream effects of poor sexual health and reduced social mobility are seldom studied in research.
In a study of 3000 women published in the Indian Journal of Urology, 21.8 percent were found to be incontinent. 73.8 percent of them had Stress Incontinence, followed by Mixed (16.8) and Urge (9.5 percent) Incontinence. Postmenopausal status, body mass index (BMI) greater than 25, history of diabetes and asthma, and habitual tea, tobacco and/or betel leaves consumption were found to be risk factors associated with increased prevalence of urinary incontinence. Based on a multivariate analysis, being more than forty years old, multiparity, vaginal delivery, hysterectomy, menopause, tea and tobacco intake, and asthma were found to be significantly associated with overall incontinence.
Current Treatments in India
Why DTx in India?
The portability of one particular DTx has made access to therapy possible even in remote locations, and with comparative cost much less than lifetime usage of pharmaceuticals or surgery, DTx has become the ideal solution for a country like India, which almost always gets access to new drugs only after generics become available. DTx leaps ahead of generics in making therapeutic available early, at scale.