Axena Health, a medical device company specializing in female pelvic health, has announced that its Leva Pelvic Health System will be included in a significant clinical study funded by the National Institutes of Health’s (NIH) Pelvic Floor Disorders Network (PFDN). The study, titled “Training for Urinary Leakage Improvement after Pregnancy” (TULIP), aims to compare three first-line treatments for postpartum urinary incontinence (UI).
The TULIP study (NCT06411158) is designed as a multi-center, randomized single-blind nonsurgical trial. It will enroll approximately 216 first-time mothers (primiparous women) who are at high risk for prolonged or sustained pelvic floor disorders and are experiencing symptomatic, bothersome UI amenable to nonsurgical treatment. The study comprises three arms: two active interventions and a patient education control arm. The first active intervention arm focuses on pelvic floor muscle training (PFMT) guided by an interventionist. The second active intervention arm utilizes the Leva home biofeedback device. The third arm, serving as the control, involves patient education about Kegel exercises and lifestyle changes, referred to as “usual care.”
Axena Health will provide 72 Leva devices, along with technical support and coaching sessions for participants using the devices. The primary outcome of the study will be assessed at 6 months postpartum by blinded outcomes assessors, with follow-up continuing until 12 months postpartum. This extended follow-up period will provide valuable insights into the long-term effectiveness of the different treatment approaches.
This multi-center clinical trial involves six leading research sites across the United States, including Duke University, University of California at San Diego and Kaiser Permanente, University of Chicago, University of Texas Southwestern Medical Center, University of Pennsylvania, and Women and Infants Hospital (Brown University). The PFDN, funded by the NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), aims to study pelvic floor disorders and provide evidence-based answers about treatment options.
Dr. Samantha Pulliam, Chief Medical Officer for Axena Health, said: “Pelvic floor muscle training is a globally recommended first-line treatment for urinary incontinence. TULIP is designed to understand the value of PFMT to treat UI in postpartum women and provide clinicians valuable guidance about the available therapy options for these women who experience troubling UI after having a baby. First-line treatment works, and data that guides clinicians and women toward an effective modality will help more women recover effectively after childbirth and enjoy life without the significant social, financial, emotional and physical burdens of incontinence.”
Pelvic floor disorders (PFDs) affect one-third of women globally, with UI being the most common, affecting 62 percent of adult women in the U.S. Despite the effectiveness of PFMT as a first-line treatment, lack of awareness contributes to low care-seeking behaviors, placing women at risk for various burdens. Untreated UI symptoms often worsen over time and are the second leading reason for older women entering nursing homes.
The Leva Pelvic Health System offers a non-invasive, medication-free approach for women to train and strengthen their pelvic floor muscles at home. The system combines an FDA-cleared vaginal motion sensor with integrated software, providing real-time visualization of pelvic movement, progress tracking, and active physician involvement. Available by prescription only, the Leva System allows physicians to treat UI and chronic fecal incontinence (FI) on a broad scale while maintaining involvement in patient progress.
