US company launches large-scale study to investigate the “burdens” of incontinence

The US medical device company Axena Health has announced a large-scale study to investigate the “burdens” of incontinence on women in low- and middle-income countries and improve access to treatment.

The study will examine how women could access treatment within local healthcare delivery systems and in a manner that accommodates cultural norms.

The results, the company says, will be available in late 2023 and will inform the development of new treatment options based on the Leva Pelvic Health System, a digital health treatment for urinary incontinence (UI).

“When it comes to incontinence, there is a need to generate community awareness that it is treatable and sensitisation and training of health workers to increase screening, deliver conservative and surgical treatment, and provide adequate follow-up,” says Mohan Chandra Regmi, Professor of Obstetrics and Gynaecology and chief policy advisor for the Government of Nepal.

“The scope is simply huge.”

Approximately one-third of women in low- and middle-income countries experience at least one pelvic floor disorder, such as urinary or faecal incontinence.

Pelvic floor muscle training (PFMT) is globally accepted as first-line treatment for bladder and bowel leakage.

Beginning in Nigeria and Kenya, the study will gather feedback from women living with incontinence, their family members, and clinicians to gain perspective on the impact of incontinence on women’s daily lives, symptom management strategies and how they access treatment through local healthcare systems.

Axena Health says it will use these data to develop a treatment with Leva technology to support access to effective treatment for incontinence that is “culturally acceptable” and available within existing healthcare pathways.

A second phase of the work will include formative and implementation research and is expected to include additional countries in Africa and South Asia.

“Urinary incontinence is a global health problem,” says Jessica McKinney, Axena Health’s VP of clinical affairs and global health.

“The physical, psychosocial, and economic burdens for women are significant and have been well documented primarily in high income countries. There is evidence in all settings that women’s livelihoods may be negatively impacted, and they may experience limited participation in family and community life.

“It is also true that UI is universally undertreated, and many women live with the health condition for the rest of their lives.

“Our intention with this study is to better understand and share women’s lived experiences with incontinence and direct actionable changes in awareness and treatment.”

The World Health Organization identifies urinary incontinence as a maternal morbidity and as a health priority for aging women, which includes a “strong recommendation” for PFMT.

Data from the US indicates that as few as 25 per cent of women with a pelvic floor disorder perform PFMT despite a clinician’s direction. Of those who perform PFMT, fewer than 25 per cent perform exercises adequately.

Eileen Maus, CEO of Axena Health, says female incontinence is a significant unmet health need for millions of women worldwide.

“We believe we’re uniquely able to help,” she adds.

“We’re grateful to our funding partner, AXA IM Alts, which is committed to providing innovative solutions to global health challenges and supports our goals.

“Our hope is that this work will help strengthen health systems and build greater capacity for women’s healthcare with key partners in lower-resourced settings in and outside of the US.”