FemPulse Ring receives EU approval for overactive bladder

The FemPulse Ring, a nonimplanted vaginal neuromodulation device designed to manage overactive bladder (OAB) in women, has received CE marking under the European Union Medical Device Regulation (MDR), FemPulse announced in a news release.¹

The company said the device is now registered in the European Database on Medical Devices (EUDAMED).

“I am excited that the over 50 million women in Europe suffering from OAB will now have access to our non-invasive, patient-friendly therapy,” said Alexandra L. Haessler, MD, the urogynecologist-developer of the FemPulse Ring and founder and chief medical officer of FemPulse, in the news release.¹ “My goal has always been to offer women around the world the proven effectiveness of neuromodulation without invasive surgery and as a first-line alternative to limited-efficacy drugs.”

About the FemPulse Ring

The FemPulse Ring is a wireless vaginal device designed to be inserted, worn continuously, and removed by the patient. According to the manufacturer, the ring is retained in the upper vagina and contains 8 programmable surface electrodes intended to provide electrical stimulation to nerves involved in bladder control.

CE marking was granted under the EU MDR. Under the MDR, manufacturers must demonstrate conformity with applicable general safety, quality, and clinical performance requirements.

FemPulse said positive safety and efficacy findings from 4 clinical studies supported the CE marking. The device remains investigational in the US and is being explored in a randomized pivotal study, EVANESCE-II (NCT07195656). The methodology for the pivotal trial was presented at the 2026 American Urological Association Annual Meeting.²

EVANESCE-II is a prospective, multicenter randomized study evaluating the FemPulse System in up to 151 women with OAB. Participants in the study are randomly assigned 2:1 to FemPulse or standard-of-care OAB medication with tolterodine. To be eligible for enrollment, patients need to be experiencing 11 or more voids per day and no more than 2 urgency incontinence episodes per day.

The primary end point for the study is non-inferiority between the device and medication arms in mean change in voids per day from baseline to week 26 based on a 7-day bladder diary. Completion of the study is expected in December 2027.³

REFERENCES

1. FemPulse Ring gains CE Mark certification for the EU. News release. FemPulse. September 17, 2026. Accessed September 24, 2026. https://fempulse.com/news_home/fempulse-ring-gains-ce-mark-certification-for-the-eu/

2. Sutherland SE. RCT PIVOTAL IDE TRIAL OF NON-INVASIVE WIRELESS WEARABLE VAGINAL RING (FEMPULSE) COMPARED TO TOLTERODINE ER IN TREATING OAB (NCT07195656): EVALUATION OF A NON-IMPLANTED ELECTRICAL STIMULATION DEVICE FOR OVERACTIVE BLADDER (EVANESCE II). https://www.auajournals.org/doi/10.1097/01.JU.0001192576.10240.c7

3. Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB) (EVANESCE-II). ClinicalTrials.gov. Last updated July 13, 2026. Accessed September 24, 2026. https://clinicaltrials.gov/study/NCT07195656