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Digital Therapeutics (DTx) for Incontinence and Pelvic Pain in India
Sanjai Murali
Shyam Ramamurthy
JOGO Health
@HealthJOGO
D

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 is a new class of therapeutics for which the US FDA has created its own regulatory pathway. In essence, FDA approves a DTx for prescription by physicians if its efficacy is demonstrated through clinical trials. Advances in biosensors, machine learning, artificial intelligence, and computing power available in mobile handheld devices, have coalesced in a beneficial way to create this new class of therapeutics.

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

DTx is fairly a new concept successfully introduced by several developers in India. Adoption of DTx in India has been significantly higher compared to some other global markets, primarily driven by a cash payment system and the unmet need to treat various conditions, especially incontinence and pelvic pain.

Incontinence and Pelvic Pain in India

The World Health Organization (WHO) included Incontinence and Pelvic Pain in their Call to Action for Rehabilitation 2030 initiative.

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

Current treatment modalities for both incontinence and pelvic pain in India revolve around prescribing anticholinergic and analgesic drugs. According to a recent study published in JAMA, exposure to several types of strong anticholinergic drugs is associated with an increased risk of dementia. This study also recommended the importance of reducing exposure to anticholinergic drugs in middle-aged and older people. But anticholinergic and analgesic drug classes only treat the symptoms, not the root cause.

Why DTx in India?

Almost all DTx products are based on behavioral science such as Cognitive Behavior Therapy or Biofeedback. Evidence in behavioral medicine shows that these treat the root cause of incontinence instead of only the symptoms, and they are much safer than pharmaceuticals. For example, the American Urology Association recommends Behavior Therapy as the first line of treatment (before patients are prescribed pharmaceuticals) for Overactive Bladder (OAB), and many urologists prefer DTx products to treat incontinence.

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.

How are DTx Delivered?

DTx are provided at a doctor’s clinic, hospital, or via homecare or telemedicine. Some DTx are self-administered (by the patient) and tracked by the prescribing clinician, while others are administered by a physician’s assistant, therapist, or coach. Adherence to the protocol upon which the DTx was approved is paramount in every scenario. Adherence can be enforced digitally or by the clinician supervising the delivery of DTx.

Conclusion

DTx offers compelling value in terms of outcomes, cost, and access. Given their early success, and as more clinical trials prove the efficacy of DTx. either as a standalone modality or in combination with a therapeutic drug or surgical intervention, the adoption of DTx will grow in scale.
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