Bioelectronic medicine company FemPulse has enrolled its first participant in a clinical trial evaluating physiological responses to its overactive bladder (OAB) technology.
FemPulse focuses solely on treating OAB in women. The company is working on developing the FemPulse System, a neuromodulation device designed to provide mild electrical nerve stimulation to regulate the bladder and relieve OAB symptoms.
The device takes the form of a small, non-implantable vaginal ring intended to be worn around the cervix, which provides mild electrical stimulation to the autonomic nerve plexuses involved in bladder control. It is designed to be worn for days or weeks at a time, giving OAB patients the option for discreet, continuous therapy.
FemPulse founder and chief medical officer Dr Alexandra Haessler said: “Currently, there are limited convenient and effective treatment options for women suffering with OAB. The enrollment of our first participant in this study is an important milestone as we strive to provide a minimally invasive treatment that will improve the quality of life for women impacted by this condition. We look forward to the final results as a further validation of our mission to address this unmet need with a truly unique solution.”
Observations from FemPulse’s feasibility study are hoped to help provide a greater understanding of the mechanisms of OAB, as well as enable the tailoring of treatment plans for individual patients.
Subjects of the study will undergo non-invasive monitoring during the activation of the FemPulse System. Researchers will use a Quantitative Sudomotor Axon Reflect Test (QSART) to detect changes in autonomic nervous system activity during device activation, while surface electrodes will be used to detect whether activation of the device has a practical effect on OAB symptoms.
FemPulse expects to reveal data from the study in the second half of 2019.
Hennepin Healthcare neurologist and principal investigator of the study Dr Adam Loavenbruck said: “The FemPulse System is a promising advancement in the OAB field as it represents a potential solution that could offer women the ability to improve their quality of life and regain their independence. This study will help further establish the ability to individualise therapy parameters and I look forward to working with more patients.”