Michael Barbella, Managing Editor06.29.23
Providing the same relief for overactive bladder (OAB) for which it is known in the stress urinary incontinence arena, Elidah has introduced its newest product, ELITONE URGE, the first and only non-intrusive treatment for urge incontinence.
This latest device, a natural successor to ELITONE, is specified to treat urgency bladder leaks that afflict 33 million women in the United States. ELITONE URGE is an external, non-implanted muscle stimulator that outputs signals to calm the muscles and nerves that cause urgency or OAB leaks. The patented design maximizes comfort and efficacy, while being discreet and wearable under clothes, for urge incontinence therapy.
Clinically Proven Treatment
ELITONE URGE received U.S. Food and Drug Administration (FDA) clearance to treat urgency leaks after achieving clinically significant leak reduction for 76% of study participants after six weeks of treatment. Nearly all women in the study (97%) achieved some reduction in urge leaks, and all quality of life metrics showed improvement. ELITONE URGE has fewer side-effects than incontinence medication. The device is potentially a life-changing option for tens of millions of women, many of whom are older and whose best solutions in the past might have been pads, diapers, or simply staying close to the restroom at all times. ELITONE URGE is clinician recommended and available without a prescription.
“Before ELITONE URGE, there were no efficacious at-home treatments for OAB leaks,” Elidah CEO Gloria Kolb said. “Incontinence medications are problematic, and invasive implants are often not lasting solutions. By ensuring women can easily and safely treat their leaks without side effects, we know we will be helping millions of people cost-effectively.”
ELITONE URGE is the first and only FDA-cleared home overactive bladder treatment device that is available over-the-counter. Elidah sought clearance for OTC availability, a far more intense approval process than for prescription, to substantially increase the access to a proven treatment in the growing OAB market. “We felt it critical to meet OAB sufferers where they are,” Kolb noted. Millions of women who struggle with overactive bladders now do not need to get office treatments for improved outcomes, and can ultimately lower their overall healthcare costs.
“After two surgeries, multiple OAB treatments, and bladder botox - nothing helped. I was getting up every hour or two to use the bathroom,” complained Jackie, who participated in the clinical study. “But ELITONE URGE is awesome. I now have very few, if any, ‘accidents’ and I can go much longer between bathroom visits—which means I can go shopping without finding a restroom in every store.”
Elidah is a woman-owned medical device company based in Connecticut. With FDA-cleared ELITONE and ELITONE URGE, the company delivers women’s healthcare options that are clinically effective, dignified, and improve lives.
This latest device, a natural successor to ELITONE, is specified to treat urgency bladder leaks that afflict 33 million women in the United States. ELITONE URGE is an external, non-implanted muscle stimulator that outputs signals to calm the muscles and nerves that cause urgency or OAB leaks. The patented design maximizes comfort and efficacy, while being discreet and wearable under clothes, for urge incontinence therapy.
Clinically Proven Treatment
ELITONE URGE received U.S. Food and Drug Administration (FDA) clearance to treat urgency leaks after achieving clinically significant leak reduction for 76% of study participants after six weeks of treatment. Nearly all women in the study (97%) achieved some reduction in urge leaks, and all quality of life metrics showed improvement. ELITONE URGE has fewer side-effects than incontinence medication. The device is potentially a life-changing option for tens of millions of women, many of whom are older and whose best solutions in the past might have been pads, diapers, or simply staying close to the restroom at all times. ELITONE URGE is clinician recommended and available without a prescription.
“Before ELITONE URGE, there were no efficacious at-home treatments for OAB leaks,” Elidah CEO Gloria Kolb said. “Incontinence medications are problematic, and invasive implants are often not lasting solutions. By ensuring women can easily and safely treat their leaks without side effects, we know we will be helping millions of people cost-effectively.”
ELITONE URGE is the first and only FDA-cleared home overactive bladder treatment device that is available over-the-counter. Elidah sought clearance for OTC availability, a far more intense approval process than for prescription, to substantially increase the access to a proven treatment in the growing OAB market. “We felt it critical to meet OAB sufferers where they are,” Kolb noted. Millions of women who struggle with overactive bladders now do not need to get office treatments for improved outcomes, and can ultimately lower their overall healthcare costs.
“After two surgeries, multiple OAB treatments, and bladder botox - nothing helped. I was getting up every hour or two to use the bathroom,” complained Jackie, who participated in the clinical study. “But ELITONE URGE is awesome. I now have very few, if any, ‘accidents’ and I can go much longer between bathroom visits—which means I can go shopping without finding a restroom in every store.”
Elidah is a woman-owned medical device company based in Connecticut. With FDA-cleared ELITONE and ELITONE URGE, the company delivers women’s healthcare options that are clinically effective, dignified, and improve lives.