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Female Urinary Incontinence

A difficult discussion

BY Shravya Kovela, PT, DPT, OCS 

This gap between how many women have UI and how many actually report it during a clinic visit is significant. Family medicine and primary care have a real opportunity to improve patient health by addressing this topic. Women who do eventually raise incontinence with a physician are most likely to bring it up in primary care, during an annual visit. No other specialty is positioned to regularly screen for UI. Women who do not bring up their UI, if screening doesn’t happen in primary care, will go without diagnosis and without treatment.

Hiding in Plain Sight

Urinary incontinence is the involuntary loss of urine. The most common diagnostic categories are stress urinary incontinence (SUI), urge urinary incontinence (UUI), and mixed urinary incontinence (MUI).

SUI is the involuntary loss of urine that occurs with increased intra-abdominal pressure — coughing, sneezing, laughing, lifting, or exercise. A common cause is weakened or poorly coordinated pelvic floor muscles that normally keep the urethra closed under pressure. SUI disproportionately affects women. Pregnancy, childbirth, hormonal changes during lactation, perimenopause and the anatomical demands of the female pelvis all drive prevalence far higher than in men, for whom incontinence is more often tied to a specific surgical or neurologic event.

Research suggests that 62% of adult women experience urinary incontinence.

In women, SUI tends to develop gradually and cumulatively, which means it rarely announces itself as a discrete problem a patient thinks to schedule a visit around. Many women first notice symptoms earlier in life, for example after a first pregnancy, and describe the leakage as occasional and situational, something they can manage rather than something they should mention.

That framing has real costs, and they compound over time. Left unaddressed, SUI is strongly associated with reduced physical activity, social withdrawal, sleep disruption, sexual dysfunction and depressive symptoms. Urinary incontinence more broadly is a well-documented contributor to fall risk in older women, particularly from bathroom trips in the middle of the night.

One study found that a third of mid-life women scale back or stop exercise altogether specifically to avoid leakage during activity, a workaround that trades one long-term health risk for another. Women with incontinence report modifying their wardrobe, limiting fluid intake and avoiding social interactions to manage leakage. Annual out-of-pocket spending for routine care, such as covering pads and protection, can cost between $900 to $4000. This tends not to reach a chart note because it is not presented by the patient as a medical concern. It's simply absorbed into how a patient goes about her week, her month, her years, often for years before it’s ever named out loud in a clinical setting.

Starting the Conversation

Barriers to discussing UI exist on both the patient and the clinician sides. On the patient side, a Michigan poll found that women do not bring up their UI because they think it isn’t a real health issue or one that can be addressed without surgery. This is related to a persistent belief that leakage is a normal and unavoidable consequence of childbirth or aging, and simply never bring it up because they were never asked. Notably, about half of women in that same poll said they find it easier to discuss urinary leakage with a female physician, a detail worth factoring into how and by whom the topic gets raised in practice.

On the clinician's side, incontinence competes for time in a visit against a long list of other concerns and necessary screenings. It’s easy for a symptom the patient hasn't raised to simply not come up. Some clinicians default to the assumption that beyond suggesting at-home Kegels, which many patients struggle to do correctly on their own, effective treatment means referral to specialty care, such as surgical consult or pelvic floor physical therapy. But these resources aren’t always available in a community, and even when they are, they’re not accessible or palatable to every patient, leading to drop-off in care and poor adherence. Without an easily accessible conservative option to offer during the visit, there's less incentive to open the conversation proactively when time is already limited.

The Michigan poll’s authors put it plainly in their conclusions ­— incontinence is unique among conditions this prevalent in lacking routine screening, and primary care physicians are best positioned to close that gap simply by asking. A statement by Dr. Wanda Filer, MD, MBA, FAAFP and board director at Pelvital USA, summarizes this well, "Primary care clinicians know that we have to be screening for everything and there’s just not enough hours in the day. Clearly, urinary incontinence is something that women, in particular, don’t talk about. It’s been normalized, which is sad, expensive and delays access to better care. If we don’t ask, they may not willingly tell us because it’s embarrassing or think it’s something they have to age with. Asking one question opens the door to a conversation that may have immense impact on their lives.”

Given how many women have already privately concluded their UI isn’t worth raising on their own, if the clinician doesn’t ask, for a large number of patients, there will be no treatment and no opportunity for improved quality of life.

Changing Outcomes

Successful treatment of female UI doesn't require a new intake form or a lengthy validated instrument at every visit. The first question of the brief, validated 3 Incontinence Questionnaire (3-IQ) screening tool, is enough to open the door. It asks, “Have you leaked urine in the past three months, even a little bit?”

When asked routinely at annual exams, postpartum visits, and perimenopausal check-ins, a single yes-or-no question can alert the clinician to symptoms that would otherwise stay unspoken, even though they are negatively impacting quality of life. A positive response can then be followed with more specific, validated screening as needed, but tasking that first simple question consistently is what changes outcomes.

Next Steps

Screening only closes the gap if there's somewhere useful for the conversation to go next. Unsupervised Kegel exercises are frequently recommended as a first-line conservative option, but an estimated 30 to 50% of women cannot correctly isolate and contract these muscles from verbal instruction alone. A well-intentioned recommendation often produces little measurable benefit and, in time, poor adherence, increased frustration and feelings of failure.

From here, the options presented to a newly identified SUI patient have historically narrowed quickly to one of two options. First, a referral for pelvic floor physical therapy, which requires scheduling, transportation and repeat visits many women can't easily fit into their lives. The other option is a specialist consultation that may feel, to a patient who just barely worked up the nerve to mention leakage at all, like an alarming escalation to surgery.

Large-scale traumatic events create population-level mental health needs.

A Promising New Solution

That gap between screening and accessible, effective first-line treatment is precisely what Flyte, developed by Pelvital, was designed to address. FDA-cleared since 2020, this at-home device delivers transvaginal mechanotherapy directly to the pelvic floor musculature to treat stress urinary incontinence and weakened pelvic floor muscles.

Mechanotherapy is the clinical triggering of mechanotransduction – the process by which cells respond to mechanical stimuli – for tissue repair and rehabilitation. It has both a cellular and a neuromuscular impact. At the cellular level, mechanical stimulation deforms the cell’s cytoskeleton, triggering a reflexive repair response that recruits additional filaments and stem cells. At the neuromuscular level, mechanotherapy stimulates mechanoreceptors in muscles that activate the tonic vibration reflex (TVR). This in turn engages the proprioceptive nervous system, improving neuromuscular facilitation, motor learning and muscle memory.

Typically prescribed in family medicine or gynecology, Flyte requires minimal clinic visits, no specialist referral and no equipment apart from the device itself. It can be effective with just five minutes of use a day, for six weeks, in the privacy of the patient’s home. Women with incontinence wait an average of six or more years from symptom onset before seeking treatment, according to the National Association for Continence. Removing scheduling, travel and adherence barriers to that first step matters just as much as the treatment's efficacy.

Its efficacy is backed by clinical evidence. A prospective cohort study of 60 women with SUI, who had already failed pelvic floor muscle training (PFMT) and were referred to surgery, found that Flyte’s mechanotherapy — mechanical oscillation superimposed on device-guided Kegels — achieved continence in 82% of participants. Improvement was measured with the 1-hour pad weight stress test, with 77% remaining continent at two-year follow-up – and none going on to pursue surgery.

Building on these findings, the Pelvital SUI Training (P-SUIT) trial, a randomized, double-blinded study of 119 women, was conducted at the University of Minnesota with Nissrine Nakib, MD, director of pelvic floor medicine and professor of urology, as principal investigator. The study found that mechanotherapy delivered through the Flyte device significantly reduced 24-hour pad weight (p=<0.001) and improved quality of life scores (p=<0.001) in women with mild, moderate and severe SUI. Improvements appeared in as little as two weeks, adherence held above 80% at six weeks and roughly 7 in 10 became dry or near-dry within 2-12 weeks. Durable improvement was noted at 2-year long-term follow-up.

A subsequent review of the published literature on transvaginal mechanotherapy for SUI concluded that its outcomes on pad weight and quality of life are superior to traditional PFMT. It provided continence and durability outcomes comparable to surgery, without the risks and cost.

To better understand how Flyte performs in everyday practice, Pelvital surveyed 411 women who had been prescribed Flyte. Demographics of note were an average age of 54 (range 24-80) and an average parity of nearly 2 births. Improvement was significant and quick; in just six weeks, mean baseline pads/day reduced from 2.36 to 1.08, and improved further to 0.74 at 12 weeks and 0.59 at 6 months. Quality of life followed the same trajectory: scores on the ICIQ-UI-SF questionnaire improved from a mean of 12.43 out of 21 at baseline to 7.06 at six weeks (n=411, p<0.001), continuing to 5.55 at 12 weeks (n=266, p<0.001) and 5.07 at 6 months (n=74, p<0.001).

These improvements line up with a measurable drop in how many patients were considering surgery (from 31% at baseline to 9% at six weeks), an outcome that matters because it means fewer women need to escalate to invasive treatment. Patients also reported high satisfaction (99%) and found the device easy to use (97%), both practical considerations for an accessible, conservative treatment for at-home use.

The idea for Flyte originated with a team of researchers at the Arctic University of Norway who were using a different application of mechanotherapy to treat muscle injury and deterioration. When they noted an impact on urinary incontinence, they conceptualized a method for transvaginal delivery of mechanotherapy directly to the pelvic floor. The intellectual property was later transferred to Pelvital, a Minnesota company. Pelvital is headquartered in Eagan, Minnesota, meaning this conservative first-line option was studied, in significant part, in Minnesota's own academic medical community.

Increasing Awareness and Access

Strong data alone doesn't guarantee a treatment reaches the patients who need it, and Flyte's continued adoption focuses on the bigger picture of solving an access problem. In practice, a physician who identifies SUI on screening can prescribe Flyte much like any other prescribed treatment. The order is routed through trusted durable medical equipment partners who verify the patient's specific insurance benefits and communicate any patient cost responsibility before fulfilling, so the patient knows what she owes before committing rather than after. Insurance coverage itself has been expanding steadily, with many insurance plans in Minnesota covering it when prescribed with medical necessity.

UI affects over half of adult women and is chronically underreported in clinic visits. It has measurable long-term costs to physical health, mental health and independence the longer it goes unaddressed. There is, however, an accessible, evidence-based, first-line option that a physician can prescribe when appropriate, with the patient able to start using it at home the same week. Family physicians don't need a new screening infrastructure to address this problem. They need to ask one question, routinely, of every woman in the room — normalizing urinary incontinence and offering a treatment path that is right for the patient, opening the door to a better quality of life sooner than most patients realize is possible.

Shravya Kovela, PT, DPT, OCS, is director of clinical education and marketing at Pelvital, the Minnesota-based women's health tech company that developed Flyte.