What millions of women have been waiting for…

Neuromodulation – the individually, customizable, and discreet treatment for overactive bladder

Overactive bladder most commonly affects women

In Austria around 800,000 people, more women than men, have an overactive bladder (OAB). Worldwide, 17% of all women suffer from OAB, particularly those aged 30 to 50.

An overactive bladder (irritable bladder, urethral syndrome) impairs the way the bladder functions. Patients feel the need to urinate more often than is physically necessary. In most cases, there is no clear cause for this urge. Certain circumstances (such as stress, worry, cold feet or the sound of rushing water) can trigger an uncontrollable urge to urinate. The different triggers of this pressing need to urinate generally intensify over time, thereby leading to a steadily decreasing quality of life for those affected.

A new type of treatment, which was developed together with our partners in the US, can offer effective relief.

Neuromodulation: an innovative approach for effective treatment

The technology behind FemPulse is based on the principle of neuromodulation. It involves using gentle electrical impulses to rebalance specific nerves that control bladder function, in order to alleviate overactive bladder symptoms.

The discrete, individualized FemPulse treatment uses a vaginal ring which can be used continually for up to 30 days. The ring is so user-friendly that it can even be used at home. It is controlled using an easy-to-use interface, namely a smartphone app. Patient-specific, individually controllable electrodes make for a customizable approach to treatment, which is tailored to the needs of the respective patient.

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Basic technique developed in the USA

Dr. Alexandra Haessler, a urogynecologist, is the brains behind the technique on which FemPulse is based. Her mission is to develop an application that is both affordable for patients and is as user-friendly as possible, improving the everyday lives of those dealing with overactive bladder. Dr. Haessler, a successful surgeon in her own right, developed the effective FemPulse treatment by drawing on her many years of experience in urogynaecology and her comprehensive understanding of neuroanatomical and physiological principles.

Fempulse GmbH has picked up where Dr. Haessler left off by continuing this research. In doing so, the Austrian med-tech start-up is proudly following in the footsteps of the Medical University of Vienna.

Developing FemPulse:

FemPulse Science

Neuromodulation, using low-level electrical current, is a common therapy to treat medical conditions. It is believed to work by altering aberrant nerve behavior. Electrical impulses are delivered to positively influence nerve communication and muscle and end-organ sensation and function. FemPulse wearable technology is based on the neuroanatomy and neurophysiology of bladder control.

AUA Guideline

FemPulse’s mission is to offer non-implanted electrical stimulation (neuromodulation) as first-line treatment for OAB and the additional indications addressed by the FemPulse neuromodulation platform. The American Urological Association (AUA) 2014 OAB guideline recommends noninvasive first-line treatment to all patients with OAB and outlines that these treatments can include electrical stimulation. Medication is classified second-line and more invasive neuromodulation third-line. To read the full AUA guideline click here.

FDA Approval

FemPulse will seek initial FDA 510(k) clearance as a “nonimplanted electrical continence device”. This class of devices has generally carried the nonsignificant risk (NSR) designation, and often not required clinical trials for FDA 510(k) clearance. FDA guidance listing nonimplanted electrical continence devices as an example of NSR devices is available here. The FDA provides guidance documents for incontinence device trials. FemPulse has completed both in-clinic and in-home OAB trials and plans to study other indications, for which it may then seek additional 510(k) clearance.

FemPulse and The Elegant Solution are trademarks of FemPulse LLC

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Important information: Medical devices are regulated by the responsible supervisory authority in each country. FemPulse devices have not yet been approved or released for sale in the EU and are currently only potentially available for controlled clinical investigations. The content of this website is intended for healthcare professionals only. All statements that refer to design intent must be checked for validity in the future.