NEWTON, Mass.–(BUSINESS WIRE)–Axena Health, Inc. (Axena Health), a medical device company focused on female pelvic health, unveiled the findings from a landmark study to understand the impact of urinary incontinence (UI) on women in sub-Saharan Africa. The first-of-its-kind study revealed a critical need for awareness, education, and access to evidence-based treatment. Available online, the study will inform the future development of treatment options based on the Leva® Pelvic Health System’s patented mechanism of action that will resonate with cultural norms and are accessible through local healthcare delivery systems.

“We believe there’s tremendous need for education, awareness, and care in Kenya and Nigeria and other low- and middle-income countries. We hope the insights will inspire new global, cooperative efforts that respond to these women’s voices and clinicians’ call for accessible, evidence-based treatment that’s reliable and scalable.”

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The study of 175 women and healthcare providers in Kenya and Nigeria, conducted in collaboration with global design thinking and strategy firm, ThinkPlace, showed that UI significantly affects women’s health and quality of life: lack of awareness prevents them from seeking treatment. Through conversations, focus groups and quantitative surveys, women and clinicians expressed a strong desire for education and treatment. Clinicians acknowledged the effectiveness of first-line treatment, pelvic floor muscle training (PFMT), and highlighted the need to educate healthcare workers about how to evaluate and manage pelvic floor disorders. They called for additional research to understand the prevalence of UI in sub-Saharan Africa and expressed the critical need for effective treatment that would allow them to treat large populations. Axena Health will conduct a second study in Nigeria to test the feasibility of implementing clinic-based treatment that leverages Leva’s technology.

“We believe this is the first large-scale qualitative study to document the significant burden of incontinence among women in Kenya and Nigeria,” said Oliver Muchiri, co-author of the report and Practice Lead, Service and Systems Design Unit at ThinkPlace Kenya. “We believe there’s tremendous need for education, awareness, and care in Kenya and Nigeria and other low- and middle-income countries. We hope the insights will inspire new global, cooperative efforts that respond to these women’s voices and clinicians’ call for accessible, evidence-based treatment that’s reliable and scalable.”

Pelvic floor disorders (PFDs) affect one-third of women globally: UI is the most common. Lack of awareness is pervasive and contributes to low care seeking behaviors among women. UI is associated with a myriad of negative psychosocial, economic, and physical burdens. Symptoms often worsen over time, especially if left untreated. Stigmatization can negatively impact women’s participation in the workforce, society, and family. Isolation often follows.

“This is a groundbreaking look at the burden of incontinence on women in Kenya and Nigeria that underscores the pervasive lack of awareness, which leads to the vast majority of women enduring its effects without proper treatment or supportive care,” said Jessica McKinney, DScPT, MS, co-author of ‘Implementing Physical Rehabilitation Services into Comprehensive Fistula and Maternity Care: A Training Guide for Health Workers’, co-author of the report, and Axena Health’s VP of Clinical Affairs and Global Health. “We hope it ignites interest and support for addressing the many opportunities for education, awareness-building and care to women in Kenya, Nigeria and beyond. Women and clinicians want education and treatment that can dismantle stigma and help women resolve symptoms.”

“This research showed that women recognize the importance of pelvic floor muscle exercises and clinicians want to support structured and supervised pelvic floor muscle training and education,” said Laura Keyser, DPT, MPH, co-author of the aforementioned training guide and the report, and Axena Health’s Director of Clinical Strategy and Global Health. “We hope this report elevates the conversation about pelvic floor disorders for women in Nigeria, Kenya and other low- and middle-income countries.”

“Female incontinence should be on the radar of all stakeholders with a commitment to global women’s health,” said Eileen Maus, CEO of Axena Health. “Women’s voices are uniquely critical to understanding the challenges of incontinence, particularly in regions where resources may be limited. We gave these voices a megaphone, and we must act. We welcome major funders, ministries of health and others in the global women’s health community to join us in delivering education and care to a very deserving population.”

Interested funding partners and potential collaborators may access the complete study findings here. For additional information or to discuss potential partnerships, please contact [email protected].

About the Leva® Pelvic Health System

The Leva Pelvic Health System, recently named a Medical Breakthrough in women’s health by AARP, is a prescription medical device that offers an effective, non-invasive, medication-free way for women to treat urinary incontinence (UI) and chronic fecal incontinence (FI). Combining a small FDA-cleared intra-vaginal probe embedded with multiple motion sensors and integrated software, the Leva System allows women to visualize pelvic floor muscle movement in real-time and guides them to complete their treatment correctly. Available by prescription only, the Leva System gives providers/clinicians the opportunity to treat UI and chronic FI on a broad scale and with continued involvement in patient success. The Leva System has multiple clinical trials with globally recognized medical centers supporting its efficacy in treating UI, including two studies in Obstetrics and Gynecology (The Green Journal), the official publication of the American College of Obstetricians and Gynecologists (ACOG). The U.S. Food and Drug Administration (FDA) granted the Leva System Breakthrough Device Designation in 2021 as a treatment for chronic FI.

About Axena Health

Axena Health, Inc. is a women-led company dedicated to improving the lives of women with pelvic floor disorders. Axena Health’s flagship product, the Leva® Pelvic Health System, offers a novel, effective, first-line treatment for urinary incontinence (UI) and chronic fecal incontinence (FI), underreported conditions affecting over 78 million and 12 million women in the U.S. alone. Axena Health’s technology enables non-invasive, drug-free treatment which they can do at home, in just five minutes a day while also allowing clinicians to monitor usage and progress. For more information, please visit www.axenahealth.com or www.levatherapy.com, follow Axena Health on LinkedIn and follow Leva Pelvic Health System on Instagram and TikTok.

Important Indication and Other Information for the Leva® Pelvic Health System

The Leva® Pelvic Health System is intended for (1) strengthening of pelvic floor muscles, (2) rehabilitation and training of weak pelvic floor muscles for the treatment of stress, mixed, and mild to moderate urgency urinary incontinence (including overactive bladder) in women and (3) rehabilitation and training of weak pelvic floor muscles for the first-line treatment of chronic fecal incontinence (>3-month uncontrolled passage of feces) in women. Treatment with the Leva System is by prescription and is not for everyone. Please talk to your prescriber to see if Leva System is right for you. Your prescriber should discuss all potential benefits and risks with you. Do not use the Leva System while pregnant, or if you think you may be pregnant, unless authorized by your doctor. For a complete summary of the risks and instructions for the Leva System, see its Instructions for Use available at www.levatherapy.com.