Why Urinary Retention in Women Hasn’t Changed in Decades—and What’s Finally Changing

​We’ve made extraordinary advances in medicine—from breakthrough vaccines to AI-driven diagnostics.
And yet, for women living with urinary retention, the standard of care hasn’t meaningfully changed in decades. For many, daily catheterization remains the only option. It’s not just inconvenient—it’s a chronic burden that comes with infection risk, quality of life challenges, and long-term complications.

In a recent episode of Life Sciences Decoded, I spoke with Kevin Connolly, CEO and founder of Vesiflo, about why this problem has persisted—and what it takes to finally change it.

The Condition No One Talks About

Most people are familiar with urinary incontinence—leakage. Urinary retention is the opposite: the inability to urinate. It’s a serious medical condition, often caused by neurologic diseases such as multiple sclerosis, stroke, spinal cord injury, or spina bifida. And because the root cause is neurologic, it’s typically permanent.
For these women, the body loses its ability to perform a basic function—emptying the bladder.
And the solution? A catheter.

A “Solution” That Hasn’t Evolved

Catheters are, at their core, simple tubes. They passively drain urine. In fact, the basic concept hasn’t changed since ancient times. While materials have improved, the approach remains largely the same.
The problem is that urination is not a passive process. It’s active. It requires the bladder muscle—the detrusor—to contract and expel urine. Catheters don’t replicate that function. They bypass it.
And they come with real consequences.

The Hidden Risk: Infection

• Long-term catheter use significantly increases the risk of urinary tract infections (UTIs).
• For some patients, these infections become recurrent. For others, they escalate.
• Some progress to sepsis.
• Some become fatal.

That reality became the driving force behind Vesiflo.

“I started this company for a reason,” Connolly explained. “InFlow has the potential to save thousands of women’s lives every year by keeping them from getting infected.”

Why Innovation Stalled
If the problem is so significant, why hasn’t it been solved? Connolly describes it as a “perfect storm.”

• Existing solutions are simple and widely accepted
• Large companies have built businesses around the status quo
• Women’s health has historically been underprioritized
• And perhaps most telling: If physicians don’t have a better solution to offer, patients often stop seeking care.

A Different Approach: Mimicking Natural Function

Vesiflo’s InFlow device takes a fundamentally different approach. Instead of passively draining urine, it actively empties the bladder—mimicking natural urination.
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How it Works:

• The device is inserted into the urethra and controlled externally with a handheld magnetic controller.
• With the push of a button, a small internal rotor spins, evacuating urine at a normal flow rate.
• When the user releases the button, the system stops and a valve engages to prevent leakage.
• The experience is simple—but the impact is profound.
• A woman can sit on a toilet and urinate normally.

For many patients, that moment is emotional. “It’s very usual for the patient to just cry,” Connolly said. “They’ve lost the ability to use a toilet. When they get this back—it’s a huge victory.”

More Than a Device—A Shift in Care

The challenge isn’t just building better technology. It’s changing the standard of care.
Today, many women with urinary retention are managed outside the healthcare system—trained to use catheters and sent home, often without specialist follow-up. Bringing them back into care—and introducing a new option—requires:
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• Physician education
• Patient advocacy
• Clinical validation
• Reimbursement

On that last point, Vesiflo has cleared a major hurdle. After a long and complex process, CMS granted reimbursement and described the technology as an “important life-enhancing” innovation in the Federal Register. That kind of recognition is rare—and critical for adoption.

An Overlooked Population

One of the biggest misconceptions is the size of the need. Based on available data, at least 500,000 women in the U.S. live with permanent urinary retention. But that number may be significantly higher. Why? Because many patients never enter the system in the first place.

What Comes Next?

Vesiflo is now preparing for broader U.S. launch, supported by:

• Medical societies
• Patient advocacy groups
• Physician networks

Their initial focus is training physicians and building access so patients can find providers who offer the device. Because for the first time, there is an alternative. This isn’t just a story about a device. It’s a story about:

• An overlooked condition
• A stagnant standard of care
• And the persistence required to change it

For women living with urinary retention, the ability to urinate normally isn’t a convenience.
It’s dignity. It’s independence. And in some cases, it’s the difference between recurring infection—and survival. 

For more information on Vesiflo visit: www.vesiflo.com