‘UI is not a life threatening illness, but it has a major impact on the quality of a woman’s life.’Dr. Sam Raz knew that he was onto something when he heard that all of the women who had taken part in clinical trials of a new device developed by Israeli start-up Flexiprobe to treat incontinence, asked if they could take the device home with them afterwards.
“It was very popular with the patients who tried it, and that gave us great encouragement. It’s what convinced me to get involved with the project,” says Raz, who joined the company as its CEO a year ago.
Urinary incontinence (UI) is one of those problems that people don’t really like to talk about. But in the US alone up to 12 million women suffer from UI in its various forms, resulting in an annual healthcare cost of $29.3 billion. It’s been shown that with increased age, more than 50% of all women will suffer from UI at some point in their life.
UI affects women mostly – only 7% of cases are male. There are three types of incontinence, stress incontinence, which occurs as a result of decreased urethral support, often due to sagging pelvic floor muscles. This accounts for 65% of all female UI. Or there’s urge incontinence, when a woman feels a strong, sudden need to urinate followed by an involuntary loss of urine. Or finally, mixed incontinence – a combination of stress and urge incontinence, a condition to which elderly women are particularly susceptible.
“It is not a life threatening illness, but it has a major impact on the quality of a woman’s life,” says Raz. “Many women become so worried they might have a sudden loss of bladder control that they avoid normal work environments, activities and social contact. They are often also very embarrassed and ashamed to talk about it, even with their physicians.”
At present there are several treatment methods including absorbent pads, Kegel muscle exercises, electrical nerve stimulation (ENS), drugs, and surgery, but all have their drawbacks. Major studies have shown that 80% of women who suffer from stress or mixed incontinence get relief by practicising regular Kegel exercises to strengthen and improve control of their pelvic floor muscles. The problem, however, is that it is hard to carry out the exercises for prolonged periods, and about half of the women doing them will do the exercises incorrectly, even with good instruction.
Electrical nerve stimulation of the pelvic floor, which is also meant to strengthen the pelvic muscles, is potentially an effective therapy for both stress and urge UI, a claim reinforced by industry and professional associations, but most of the devices presently on the market are not considered effective, and none of them give a long-term solution, according to Raz.
Flexiprobe’s device consists of a portable power and control unit and a flexible and lightweight probe made either of rubber or silicone that expands to fit inside the vagina. Multiple electrodes are located along the external surface of the probe and these maintain constant electrical contact with the cavity wall. When activated these electrodes stimulate the muscles and nerves of the surrounding area.
The probe also contains sensors that detect and measure muscle contraction, providing a feedback loop to gauge the progress of the treatment. The power and control unit can be connected via a USB cable to a PC, providing electrical stimulation and muscle contraction data that can be charted by the user or their physician.
The probe has a number of significant benefits over existing devices, says Raz. To begin with, it can be used at home. The ideal treatment regimen would be to use an electric stimulation device twice daily, but since most current treatments are performed in hospitals or private clinics, studies show that the average actual treatment regimen is only twice a week.
“Insufficient therapy leads to an ineffective outcome,” he told ISRAEL21c. “It makes all the difference in the world how much you use a device like this. Flexiprobe enables you to the device at home on a daily basis, 20 minutes a day for four to five weeks. Imagine going to an outpatient department on a daily basis!”
The shape is also important. Other devices can only be used when the patient is lying down. Flexiprobe’s device is made of flexible material and is designed so that it doesn’t fall out. The control unit can also be connected discreetly to a belt or clothing. This means patients can use the device as they move around the house, watch TV, or even cook in the kitchen. The shape also ensures that all of the weak muscles are treatment.
“Our device replaces the lack of continuity suffered by ENS devices to try to strengthen the pelvic muscles. In effect we are stimulating the pelvic muscles in the same way they would have been stimulated if Kegel exercises were carried out regularly and correctly,” says Raz.
Another advantage is the price. Raz expects the completed device to cost in the region of $200, compared to other ENS devices that cost between $600 to more than 1,000.
Flexiprobe was founded at the RAD Biomed incubator in 2002. The idea for the device first came from an incontinence therapist working at Tel Hashomer Hospital in Tel Aviv. She had worked in the field for 23 years and was well aware of the limitations of current treatments.
The company spent two years in the incubator during which time it carried out its pilot clinical trials at Tel Aviv’s Ichilov Medical Center. The trials involved 45 healthy women with mixed incontinence, the majority of them suffering from urge incontinence. The study lasted eight weeks.
“The results were very promising,” says Raz. “They showed overwhelming user compliance making it an attractive alternative to what is available in the incontinence treatment market. All the women who participated in the study were satisfied with the results, and all of them asked if they could keep the device. They couldn’t, however, because it was still experimental.”
Raz is now keen to carry out new clinical trials to test not only the immediate efficacy of the treatment, but also its long-term effect. A second round of clinical trials has now been arranged at two major hospitals in the US – Cedar Sinai UCLA Medical Center in Los Angeles, and Harvard Medical Centre in Boston. “We hope to show that our device is not only effective for the duration of the treatment, but also three months to a year later.”
The clinical trials are important because Raz plans to market this device through the medical profession. “Our best marketing agent in the physician,” he says. “Some of these devices are sold on the Internet without medical supervision. We want to work closely with doctors all the time and that’s why the clinical trials are important.”
Raz hopes to begin the trials within the next two to three months, and if all goes well, he believes the product, which has already been patented, could be on the market in the US one year later with FDA approval.
What the company needs now, however, is investment. Negotiations are already underway. The company hopes to raise $1 million to bring the technology through clinical trials and take it to market.
There are also plans to make improvements to the original device. The company plans to add a rechargeable battery to make the device more user friendly, and reduce its size. There are also plans to introduce a smart card with biofeedback so the patients and doctors can chart progress. “This biofeedback would be immensely useful for all concerned,” says Raz. “Both the doctors and the women want to see the progress they are making. One of the problems with Kegel exercises is that you don’t know if they are doing any good. When you see it on the computer it’s a different story.”
Raz is keen to move forward. “When I go to conferences and talk to women and doctors I realize they are waiting for a device such as ours. They need a replacement for Kegel exercises and nothing currently on the market fits the bill. Everyone is interested.”