A new device for facilitating urethral intermittent self-catheterization by female patients: results of a pilot study

Context IC performed by patients themselves is the gold standard for patients suffering from neurogenic lower urinary tract dysfunction. But the process of intermittent self-catheterization (IC) by female patients can be challenging.Design A usability study for a new assistive device, named and trademarked 2LIP®, for facilitating urethral (IC) use by female patients suffering from a neurogenic disorder of the lower urinary tract (NLUTD) was realized.Participants & Interventions Leg spreading angles (LSA), forward body push distances (FBPD) and inner labia opening forces were measured in healthy women. A volunteer study group of paraplegic and incomplete tetraplegic female patients was anonymously interviewed and/or tested the new device.Results LSA was reduced from 50–110° without the device to 20–50° with the device. The range of anteroposterior and mediolateral inner labia opening forces ranged between 2 and 18N in 4 healthy subjects. FBPD was reduced modestly. 20 paraplegic and incomplete tetraplegic female patients were interviewed. In 20 tests, the first generation 2LIP opened the labia in 3 out of 9 women because the device was mechanically too short, whereas the optimized second generation opened the inner labia in 9 of 11 subjects successfully.Conclusion 2LIP® enabled a reduction of the required LSA and a slightly reduced FBPD, which may lead to a more ergonomic, safer and facilitated self-catheterization. Labia opening forces can be used to quantify the mechanical device requirements. Women seek improvements in the self-catheterization procedure and see potential benefits from 2LIP®. Greater independence in continence is of individual and societal interest. Nursing efforts may be reduced. Easier self-catheterization may help raise the individual frequency of IC.