Axena Health, Inc., a medical device company focused on female pelvic health, has announced the commencement of a feasibility study in Nigeria to evaluate a novel treatment modality for female incontinence. The 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,” is being conducted at two research sites in Nigeria.
The interventional trial leverages the Leva® Pelvic Health System technology, coupled with a home-based digital program that provides health education and instruction on pelvic floor muscle training (PFMT). The ArcHealth Foundation, Inc., is supporting the study through a grant to facilitate in-country data management by Helium Health.
Study Design and Objectives
The prospective, single-cohort, open-label study aims to enroll 60 women at the University of Abuja Teaching Hospital and Lagos State University Teaching Hospital. Researchers will assess the acceptance and success of the clinic-based treatment, which utilizes the Leva System technology to guide PFMT, a first-line treatment for incontinence. The at-home digital program complements the clinic-based intervention by providing additional health education and PFMT instruction.
Addressing a Critical Need
Dr. Babafemi Daniyan, from the Department of Obstetrics and Gynaecology at the University of Abuja Teaching Hospital, emphasized the significant need for effective care for women experiencing incontinence in Nigeria. He noted the psychosocial, emotional, and financial hardships associated with untreated incontinence and expressed hope that the study results would expand access to relief for more women.
An estimated one-third of women worldwide experience pelvic floor disorders, including urinary incontinence (UI), fecal incontinence (FI), and pelvic organ prolapse (POP). Low awareness and associated stigma often lead to underreporting and a lack of care-seeking behaviors, leaving many women to live with untreated incontinence, which can worsen over time.
Leva Pelvic Health System
The Leva® Pelvic Health System is an innovative, non-invasive, medication-free approach for women to train and strengthen their pelvic floor muscles. The system combines a small FDA-cleared vaginal motion sensor with integrated software, providing real-time visualization of pelvic movement and enabling progress tracking. Available by prescription only, the Leva System allows physicians to actively participate in patient care and has demonstrated efficacy in treating UI in multiple clinical trials.
Global Implications
Dr. Laura E. Keyser, Axena Health’s Director of Clinical Strategy and Global Health, highlighted that the study builds upon previous qualitative research, which revealed the significant negative impacts of incontinence on women's lives in low- and middle-income countries. The new Leva-based treatment program aims to provide clinicians with an effective means to counsel women and offer evidence-based, first-line care.
Randy Pritchard, CEO of Axena Health, expressed enthusiasm for the partnership with the Nigerian hospitals and noted that the study results will inform Axena Health’s strategy for expanding beyond the U.S. market to provide treatment options for women worldwide experiencing urinary incontinence and other pelvic floor disorders.
