FemPulse is set to enter the pivotal clinical trial phase with its neuromodulation system to treat overactive bladder after the US Food and Drug Administration (FDA) awarded the company an investigational device exemption (IDE).
The prospective, multicentre, randomised controlled trial, named EVANESCE-II, will confirm the safety of the Fempulse System in women with overactive bladder and establish the device’s non-inferiority to drug therapy with tolterodine.
The pivotal trial follows previously completed clinical studies, one in the clinic and one in-home. Both studies produced positive results in safety and efficacy.
A FemPulse spokesperson confirmed to Medical Device Network that the trial "will cover approximately 150 patients across up to 15 sites in the US."
"The primary endpoint is difference in mean change from baseline to Week 26 between device and medication groups in number of voids per day (VPD), based on a 7-day bladder diary," they added.
Tolterodine, commonly sold under Pfizer’s brand name of Detrol, is an orally administered muscle relaxant and FDA-approved for treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. The drug works by relaxing the muscles in the bladder wall, helping increase the volume of urine that can be stored. Adults usually need to take two tablets in the day, one in the morning and one in the evening.
FemPulse CEO Alexandra Haessler said that “medications can have limited efficacy and intolerable side-effects, so patients discontinue them up to 80% of the time.”
US-based FemPulse has developed a vaginally inserted and removable ring that provides continuous neuromodulation therapy. The system targets nerves that regulate bladder function with pre-programmed software via a personal handheld device. Whilst needing to be replaced after six months, the ring does not require invasive surgery for implantation. Haessler calls the device an “internal wearable” that is “discreet and patient managed.”
Overactive bladder is a common condition, affecting around 16% and 16.9% of men and women respectively in the US respectively. The health care costs associated have been estimated to be around 2.5 times higher in overactive bladder patients compared to non-overactive bladder controls.
Neuromodulation is far from a new idea in the overactive bladder treatment space. Sacral nerve stimulation, a widely validated and accepted technology to treat the condition, has been around for more than two decades. This approach works by implanting a device in the lower back to stimulate the nerves that control the bladder. Sacral nerve stimulation has demonstrated high efficacy in treating the condition, though it can come with adverse events.
About one third of people with overactive bladder also experience urinary incontinence – there are multiple medtech companies specifically targeting this secondary consequence of the condition.
UroMems has developed a MyoElectroMechanical System which is placed around the urethral duct and automatically changes the sphincter opening by pressure adjustments based on the patient’s activity. The company is conducting clinical trials with its system, including a female-only feasibility trial.
Amber meanwhile raised one of the biggest Series A funding rounds for a medtech company in Europe earlier this year, bringing in $100m to advance its implantable device for women with mixed urinary incontinence.
Aviation Medical claims to have the only FDA-approved closed-loop and non-invasive neuromodulation system for bladder control in the US. Its Vivally system received FDA regulatory approval in April 2023.
A market model by GlobalData estimates the global neuromodulation device market will be worth $11.4bn by 2033, up from $6bn in 2022.
Editor's note: This article was updated on 13 December to clarify FemPulse's location is separate from Austrian-based FemPulse GmbH. Ring insertion duration was also updated.
