Axena Health Moves Forward with Patient Enrollment for UI Study
Axena Health, Inc., a pioneering medical device company devoted to female pelvic health, has made an exciting announcement. The company has started enrolling women for a feasibility study targeting a novel treatment for urinary incontinence (UI) at two research sites in Nigeria. This landmark study aims to assess a clinic-based treatment model that utilizes the innovative Leva Pelvic Health System technology, combined with a home-based digital program designed to educate and instruct women on pelvic floor muscle training (PFMT).
Research Collaboration and Support
To facilitate this essential research, the ArcHealth Foundation, a public charity focused on equitably enhancing access to health technologies globally, has provided grant support. This funding will help manage data collection within the country through Helium Health, a recognized leader in healthcare digitization in Africa. Helium Health is pivotal in ushering the continent toward a more technology-driven healthcare landscape.
Understanding the Need for Incontinence Treatment
The interventional feasibility trial builds on previous research that investigated the burden of incontinence among women in several African nations, including Nigeria. Axena Health initiated its prior qualitative study in early 2023 to better comprehend these issues and explore how local healthcare systems could effectively support women seeking treatment while respecting cultural norms.
Critical Insights from Previous Findings
The results of their earlier research indicated a significant gap in awareness, education, and access to treatments for incontinence. Researchers have now leveraged this knowledge to develop the interventional feasibility study titled "Feasibility of a Clinic-based Intervention of Biofeedback and Health Education Coupled with a Digital Home Program for Nigerian Women with Pelvic Floor Disorders." This prospective, open-label study aims to gauge women’s acceptance and the effectiveness of clinic-based treatment using the Leva system.
A Comprehensive Program for Participants
The study plans to recruit 60 participants, and it will be conducted at two institutions: the University of Abuja Teaching Hospital and Lagos State University Teaching Hospital. This structured approach combines clinical care with a digital follow-up, aiming to empower women with the knowledge they need to manage their conditions effectively.
Voices of the Research Community
Dr. Babafemi Daniyan from the Department of Obstetrics and Gynaecology at the University of Abuja emphasized the importance of this initiative, stating, "Pelvic floor disorders significantly impact women's health. There is an urgent need for education and effective care to help women facing the challenges of untreated incontinence." He expressed hope that the study will provide participants with viable treatment options.
Global Impact of Pelvic Floor Disorders
Globally, an estimated one-third of women suffer from pelvic floor disorders, which include UI, fecal incontinence, and pelvic organ prolapse. The stigma surrounding these conditions often prevents women from seeking necessary care, leading to worsening symptoms and increased psychosocial and economic burdens. The lack of awareness is particularly prevalent in low- and middle-income countries, exacerbating these challenges.
Supporting the Study's Mission
Natalie Meyer, president of ArcHealth Foundation, remarked on the significance of supporting this study, noting that female incontinence is a critical global health issue affecting women's participation in various aspects of life. She believes that the Leva System's strong clinical evidence can provide sustainable relief for women experiencing urinary incontinence symptoms.
Future Prospects for Axena Health
According to Dr. Laura E. Keyser, the study's lead researcher and Axena Health's Director of Clinical Strategy and Global Health, the insights gained from this research will guide the development of future treatment protocols. The goal is to ensure that clinicians have the tools needed to deliver effective, evidence-based care.
Commitment to Global Solutions
Randy Pritchard, CEO of Axena Health, expressed enthusiasm about collaborating with local hospitals in Nigeria. He stated that the results of this study will provide valuable insights that could aid in Axena Health's expansion efforts beyond the U.S. market, ultimately offering life-changing treatment options to women worldwide facing challenges like urinary incontinence.
Frequently Asked Questions
What is the purpose of the study being launched by Axena Health?
The study is aimed at testing a novel clinic-based treatment model for urinary incontinence in women, including education on pelvic floor muscle training.
How many participants will be involved in the feasibility study?
Sixty women will be enrolled for the study, which will take place at two major teaching hospitals in Nigeria.
What technology is being used in this study?
The study will leverage the Leva Pelvic Health System, a non-invasive medical device designed for pelvic floor muscle training.
How does the program combine clinical and digital health?
Participants will receive both in-person clinical care and a digital health program to support their treatment at home.
What broader impact does Axena Health aim to achieve with this study?
Axena Health hopes to enhance access to effective treatments for women globally, aiming to reduce stigma and improve health outcomes for those experiencing pelvic floor disorders.
