FDA greenlights pivotal trial of wearable bioelectronic device for OAB

The FDA has granted an Investigational Device Exemption approval to initiate the launch of EVANESCE-II, the pivotal clinical trial of the FemPulse Ring for patients with overactive bladder (OAB), FemPulse announced in a news release.¹

The FemPulse Ring has already been assessed in 2 previous clinical trials.

According to the company, FemPulse is a wearable bioelectronic device intended to “provide mild electrical nerve stimulation as a first-line alternative to pharmaceutical medications.”

The EVANESCE-II trial will evaluate the device in comparison with first-line drug therapy with tolterodine (Detrol).²

“I created the vaginally-inserted and removable FemPulse Ring as an ‘internal wearable’ to provide continuous OAB neuromodulation therapy without requiring surgery,” explained Alexandra Haessler, MD, founder and Chief Medical Officer of FemPulse, in the news release.¹ “The wearable ring is discreet and patient-managed with a ‘set it and forget it’ approach. Medications can have limited efficacy and intolerable side-effects, so patients discontinue them up to 80% of the time. The trial is randomized against medication to confirm the FemPulse Ring as a first-line alternative to medications. Implanted sacral neuromodulation therapy is effective but invasive, and access to surgical implantation is limited, especially outside the U.S. In 25 years as the ‘gold standard’ treatment, less than 1% of OAB sufferers have been treated with this approach. We look forward to increasing access to neuromodulation therapy for the millions of women suffering from OAB.”

The FemPulse Ring has already been assessed in 2 previous clinical trials: an in-clinic usability study (NCT06347380) and an in-home study (EVANESCE-OAB; NCT03784170).

According to data presented at the 2018 American Urological Association (AUA) Annual Meeting,³ the initial in-clinic study included 12 participants across 2 clinical trial sites.Patients included in the study had OAB symptoms with or without urge urinary incontinence (UUI).

On efficacy, the authors noted, “All subjects were able to identify and localize anatomically sensations at 3 thresholds on each of 8 electrode combinations.”

Additionally, data showed that compared with baseline measures, 50% of patients experienced a reduction in urge-related bother, 67% of patients experienced a longer maximum time between voids, and 57% of patients achieved dry status.

Regarding safety, no device-related adverse events were reported.

Overall, the authors concluded, “The FemPulse intravaginal device is wearable, safe and provides a promising non-surgical form of continuous neuromodulation delivery for the treatment of OAB and UUI.”³

The second study, EVANESCE-OAB, enrolled 21 patients with OAB across 3 clinical trial sites.

Data from the prospective trial were presented at the 2020 AUA Annual Meeting,⁴ which included results from 17 patients who completed the protocol. Of those, 83% of patients in the treatment cohort experienced a reduction of greater than 1 void per day associated with urgency compared with 33% of those in the control cohort. Additionally, 67% of patients in the treatment arm experienced an improvement in UUI-related quality-of-life vs 33% of patients in the control arm.

Based on these data, the authors concluded, “In a controlled clinical trial, the wearable FemPulse neuromodulation device is safe, comfortable, and provides a promising bioelectronic alternative for the treatment of OAB.”⁴

Building off these previous studies, the primary aims for the EVANESCE-II trial are to confirm the safety of the FemPulse System and to establish noninferiority to first-line tolterodine.²

Suzette E. Sutherland, MD, MS, FPMRS, the director of female urology at the University of Washington in Seattle, said in the news release, “My hands-on experience using the FemPulse Ring with patients and the clinical trial results confirmed my strong belief in FemPulse’s wearable therapy. I am thrilled to support FemPulse in this multi-center IDE trial and look forward to once again sharing the results at international conferences.”

In the EU, the FemPulse System has advanced to the final stage of the process for commercial clearance.

“It is exciting that our FemPulse Ring may be commercially available in the EU in 2025,” Haessler added in the news release.¹ “We certainly hope to serve as many OAB patients in the EU as in the U.S.”

References

1. FemPulse receives FDA IDE approval for the pivotal clinical trial of its wearable bioelectronic device for overactive bladder in women. News release. FemPulse. December 11, 2024. Accessed December 12, 2024. https://www.globenewswire.com/news-release/2024/12/11/2995715/0/en/FemPulse-Receives-FDA-IDE-Approval-for-the-Pivotal-Clinical-Trial-of-its-Wearable-Bioelectronic-Device-for-Overactive-Bladder-in-Women.html

2. Studies. FemPulse. Accessed December 12, 2024. https://www.fempulse.eu/en/studies/

3. Sutherland SE, Siegel S. A novel wearable, intravaginal device for continuous neuromodulatory treatment of overactive bladder. Presented at: 2018 American Urological Association Annual Meeting. April 2018. San Francisco, California. Abstract PD32-11. https://www.auajournals.org/doi/10.1016/j.juro.2018.02.1554

4. Sutherland SE, Kennelly MJ, Siegel SW. Evaluation of a non-implanted, transvaginal, electrical stimulation continence device for overactive bladder: EVANESCE-OAB. Presented at: 2020 American Urological Association Annual Meeting. PD27-09. https://www.auajournals.org/doi/10.1097/JU.0000000000000884.09