Axena Health has launched a feasibility study in Nigeria to explore a new treatment for female incontinence, combining the Leva® Pelvic Health System with a digital home-based program. The study, funded by ArcHealth Foundation and supported by Helium Health, is enrolling 60 women across two teaching hospitals in Abuja and Ikeja. This research builds upon a previous qualitative study that highlighted the substantial burden of incontinence on women in Kenya and Nigeria, revealing an urgent need for increased awareness, education, and access to treatment.
This study holds significant implications for women’s health in Nigeria and potentially other low- and middle-income countries. Incontinence carries a heavy social and economic burden, often preventing women from fully participating in work and family life. This research directly addresses this issue by investigating a novel treatment approach designed to be accessible and culturally appropriate. Positive results could lead to wider availability of effective incontinence care, significantly improving the quality of life for countless women. Furthermore, successful implementation of the combined clinic-based and digital home program could serve as a model for delivering other healthcare services in resource-constrained settings.
This study is a prospective, single-cohort, open-label trial evaluating the acceptability and effectiveness of a combined treatment approach. Participants will use the Leva System, a biofeedback device for pelvic floor muscle training (PFMT), within a clinical setting. This treatment is supplemented by a digital program providing health education and PFMT instruction for at-home use. The partnership with Helium Health ensures robust local data management, crucial for evaluating the program’s feasibility. ArcHealth Foundation’s grant funding underscores the importance of this research in addressing a global health disparity.
The results of this study are expected to shape Axena Health’s strategy for expanding access to pelvic health solutions globally. Positive findings could pave the way for broader adoption of the Leva System and digital health programs in low- and middle-income countries, addressing the significant unmet need for effective incontinence treatment. This research could ultimately contribute to a shift in how pelvic floor disorders are managed in these regions, empowering women to seek care and improve their well-being. This innovative combined approach has the potential to serve as a model for delivering other essential healthcare services in underserved communities.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
