A newly-developed medical device promises to offer fresh hope to millions of women in Europe who suffer from a prolapsed bladder, a common condition in women often caused by childbirth and menopause.
When pelvic floor muscles and tissues are stretched or become weak, the bladder can drop and bulge through this layer and into the vagina.
This results in bladder prolapse and, currently, it is estimated that more than 50% of women worldwide suffer from what is called “pelvic floor dysfunction.”
This might include stress urinary incontinence, faecal incontinence or pelvic organ prolapse (POP).
However, a “user-friendly” device developed by an Israeli company offers a completely novel non-surgical and disposable management option for women with POP.
Dr Elan Ziv, CEO & medical director of ConTIPI, said, “This device seeks to meet an unmet need for millions of women. This is all about shifting control from the doctor to the woman. It opens a whole new era in the management of pelvic floor dysfunction.”
Dr Ziv told this website that as many as half of all women who give birth may be affected by pelvic floor dysfunctions , the equivalent of one woman out of two being at risk to the condition in Europe alone. Of the estimated 135 million women suffering from POP worldwide, 28% live in Europe.
The new 25mm device for POP, which has been six years in development, is ready for the market and has a CE Mark for marketing in Europe and a clearance from FDA for marketing in the US, he said.
Unlike current devices, the item is disposable and can be used for up to seven days. It is inserted in small dimensions within an applicator into the vagina by the user herself (not a medical practitioner) at home or wherever she wants (not at the clinic).
Dr Ziv was in Brussels to help raise awareness of the condition, said to affect about 135m women worldwide. Only ten million of these are thought to have sought help, he said. At present, he said about 92 per cent of those affected are unwilling to talk about the condition because it is still seen as a “taboo” subject.
“In that sense, you can liken it to sexually transmitted diseases in the past although it is actually worse than that because it affects more people.”
While the condition is most prevalent in the ageing population, he says he has treated women in their mid-30s.
He adds, “Many women still simply do not want to talk about this as it is seen as some sort of deformity. It is an uncomfortable issue. The problem is that there is a real chance of this reaching epidemic proportions in the next 20 years unless it is properly addressed now.”
The device, he stressed, has been subject to “huge” clinical trials in Israel and the US and its efficacy and safety is “proven.”
While the number of affected women is huge, current mode of management is uncomfortable and accompanied by pain, infections and inability to have intercourse.
Israel is a well established hub for innovations and inventions, in almost every part of medicine, but in the pelvic floor arena in women there has been no innovation for the last 23 years.
The woman’s health arena (FemTech), is one of the upcoming hot topics in the 2025 and ConTIPI has already produced a device for stress urinary incontinence in women which is already on shelves in North America.
As a urogynecologist, Dr Ziv, who was trained in London, has a long standing interest in the non-invasive treatments of urinary incontinence and of pelvic organ prolapse in women.
He said, “The main aim is to help raise awareness of this condition and to make it known that there is now real help available for women who have this condition. This is complete out-of-the-box way of thinking and can help improve the lifestyle of countless number of women.”