Wellness

A Urinary Incontinence Device to Prevent Bladder Leaks

A Urinary Incontinence Device to Prevent Bladder Leaks

A Urinary Incontinence Device
to Prevent Bladder Leaks

In partnership with our friends at INNOVO

As a clinician and a researcher, Ruth Maher, DPT, PhD, has extensive experience with physical therapy for the pelvic floor to treat pain and incontinence and to support sexual health. One in three women experiences stress urinary incontinence (SUI), urine leaks caused by exertion or coughing. Exercises that strengthen the pelvic floor are an essential part of treatment; however, Maher has found that many women are unable to contract the correct muscles. Often they are unaware that this is the case. “Women would say they felt a contraction, but using ultrasound imaging, I could see that either there was no contraction of the pelvic floor muscles or other muscles, such as the glutes, were recruited,” says Maher.

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Maher saw the need for a therapy that could reliably stimulate contraction of the pelvic floor muscles to treat SUI, and she developed a prototype that delivered comfortable electrical stimulation through the skin rather than through the standard vaginal probe. This technology was the basis for INNOVO, a wearable device designed to quickly engage and strengthen pelvic floor muscles. INNOVO is FDA-cleared for the treatment of female stress urinary incontinence in the US. About women’s reactions to the device, Maher says: “They love it.”

A Q&A with Ruth Maher

Q
Why might someone seek physical therapy for the pelvic floor?
A

They may seek physical therapy if they leak urine when they laugh, cough, or exercise, or if they have pelvic pain, which has often been described as feeling like a headache in the pelvis. They may also see a therapist during pregnancy and postpartum for issues such as low back pain and urinary leakage. Stress urinary incontinence is sometimes referred to as bladder weakness, but that’s a misnomer because there’s nothing wrong with the bladder. It’s the connective tissues, muscles, and ligaments in the pelvis that provide support and keep the holes closed to keep us continent.

Urinary leakage can occur in the late teens to postmenopausal years for a variety of reasons. One study found that over 30 percent of athletes have urinary leakage. [Editor’s note: The prevalence depends on the sport—there is more urinary leakage with high-impact sports.] Another study found that in women’s rugby, over 50 percent of athletes may have urinary leakage while playing. And many people don’t talk to anybody about it. They might use a pad or give up sports.


Q
What causes urine to leak?
A

You can have pregnancy-induced stress incontinence because of the stretching of the muscles and connective tissue in the pelvic floor that is needed to allow the baby to pass through the birth canal. Computer modeling shows that these muscles can stretch up to three times their normal length during labor, leaving them unable to contract. You have little to no support down there after having a baby. So when you cough, sneeze, or even bend down to pick up your baby, you’ll involuntarily leak. That’s because those activities increase the pressure in the abdominal area and the weakened pelvic floor is unable to provide enough resistance to counteract this pressure.

Also, many women who have stress urinary incontinence will go on to develop mixed incontinence in their late forties or fifties, often associated with depletion of estrogen. Without estrogen, the sphincter muscle that keeps your urethra—the opening of your bladder—closed can become compromised. So women may end up not only with stress incontinence but also with urinary urgency.

It’s a mistake to think that only women who are perimenopausal and postmenopausal have this condition. It’s prevalent in younger women as well.


Q
How effective are Kegel exercises for strengthening the pelvic floor and solving these problems?
A

They are very effective. Kegel or pelvic floor exercises are highly recommended as a first-line treatment prior to considering surgical interventions such as slings. The problem with pelvic floor exercises is that up to 50 percent of women either can’t do them at all or they can’t do them appropriately. Since the muscles are hidden inside the pelvis and out of sight, it’s difficult to get confirmation of doing them correctly. You’ve no biofeedback. That’s the number one problem. The second problem is compliance. You have to do them several days a week, and for several weeks, to derive the benefits. In fact, pelvic floor exercises should be part of all women’s self-care regimens.


Q
Why use electrical stimulation to induce Kegels instead of a better training method?
A

I had my own practice for several years in Atlanta and then later in Ireland. I became frustrated because many women couldn’t perform voluntary contractions even with appropriate instruction. They had no awareness of how to recruit these muscles. When trying to perform contractions, they frequently contracted other muscles—their glutes or abdominals.

I thought electrical stimulation was misunderstood and underutilized. It was being used with little probes that look like tampons, but the results were equivocal. The problem with stimulation using the probes was that women would say they felt a contraction, but using ultrasound imaging, I could see that for many, the stimulation did not elicit a pelvic floor contraction. They’d say, “I can feel a contraction,” and I couldn’t see any evidence of a pelvic floor contraction. With the probe stimulation, I noted that when using ultrasound imaging I could confirm a pelvic floor contraction in only 32 percent of women despite their reporting the sensation of a contraction.

During my PhD studies at University College Dublin, I had an opportunity to use a unique stimulation platform called Multipath, which has since been patented and trademarked. Multipath uses multiple pathways to send stimulations to muscle. I used eight large electrodes around the pelvis and on the upper thighs and developed a program that sends electrical stimulation via different pathways across the pelvis. My program elicited pelvic floor muscle contractions—which I validated using ultrasound imaging—that were comfortable for the user. The surface area of the electrodes (a design later incorporated into INNOVO) is more comfortable than vaginal probe therapy because the current is spread over a very large area.


Q
How can people be sure they are doing their exercises correctly? Should they see a physical therapist?
A

Yes, I recommend seeing a physical therapist to learn how to perform the contractions appropriately. There must be some confirmation that they are contracting the correct muscles for the exercises to be effective. They either need to observe the perineum pulling in, use ultrasound imaging, or use the new test I validated, which is called coccygeal motion palpation. The therapist or individual can palpate the tailbone with their finger—even over light clothing—while the person tries to do a contraction. If the tailbone doesn’t move at all, no pelvic floor contraction is occurring. If the tailbone moves forward and away from the finger, that’s confirmation of a pelvic floor contraction. If the tailbone moves backward and toward the finger, the wrong muscles are contracting. The best way to palpate is lying down on the bed on your side if you cannot palpate when standing.


Q
Can you describe your early studies with electrical stimulation?
A

The first iteration was not shorts. It was a wrap, like chaps. No women in my initial study could perform pelvic floor contractions. I put the wrap on them, increased the intensity and verified a pelvic floor contraction using ultrasound imaging. They were then instructed to use the device at home five days a week while standing. I wanted them to do it while standing because women leak only when they’re standing, and pelvic floor muscles are challenged when in a standing position compared to other positions, such as lying down. After four weeks, I saw high cure rates, meaning no leaking and all the users were able to perform voluntary contractions. After eight weeks, most of the women reported no leakage. Within a couple of years, this first iteration evolved to become what the INNOVO device is today.

I believe electrical stimulation has benefits in addition to enhancing strength. I have seen improved neuromuscular coordination and awareness in users of what the contraction should feel like. The contraction should occur just prior to stresses such as coughing or sneezing in order to support the bladder and prevent leakage. The nervous system is wired for muscles to be activated in preparation for movement. If it were just a strength issue, women would be leaking more as the day went on and their muscles fatigued.

Because women leak during coughing, sneezing, laughing, lifting, and jumping, pelvic floor muscle weakness is not the only contributing factor; a delay in the contraction is also a contributing factor. Consequently, I focused the stimulation program on eliciting quick contractions, lasting only five seconds. I wanted to replicate the quick reflexive contraction that should occur normally during times of exertional stress in an effort to train the nervous system to respond quickly to increases in intra-abdominal pressure.


Q
How does the INNOVO device compare to being instructed to do Kegels or to use of an intravaginal stimulation device?
A

The shorts were superior to other approaches in studies. There were studies done in Germany and in the US. With the shorts, you don’t have to put anything in your vagina. Typically, women use the vaginal probes when they’re lying down, but you don’t leak when you’re lying down. You leak when you’re standing up. I think the position that you train muscles in is important. Also, the assumption with a vaginal probe is that one vagina is the same size as everybody else’s, which is not true. Sometimes you don’t have good contact with the probe, so it won’t work at all. With the INNOVO device, there are no pills, no probes, and no doctor’s visits.

After clinical trials to obtain FDA clearance and to date, there have been over 75,000 devices purchased with no adverse events reported. These trials enrolled women suffering from SUI who had failed pelvic floor physical therapy. In a multicenter controlled clinical trial, after using INNOVO, 87 percent of women were dry or had only mild symptoms.

woman sitting on bed


Q
What do women say about how stimulation with INNOVO feels?
A

They love it. I wish I’d taken photographs of their faces the first time I turned it on. Most said, “I’ve never felt anything like this before. This is really weird.” They said, “It’s an uplifting experience.”


Q
Would you expect the shorts to have benefits for more than urinary incontinence?
A

Absolutely, because if you have better pelvic floor contractions, it can improve your sex life—there’s research showing that women who do Kegels regularly get more satisfaction out of their sex life, and their partners do as well. Up to 65 percent of women with urinary incontinence leak during sex. And they often don’t tell their partners why they don’t want to have sex.


Ruth Maher is a physical therapist, a pelvic floor expert, and one of the inventors of INNOVO, a noninvasive medical device used to stimulate pelvic floor muscles and treat stress urinary incontinence. Maher has an MPT, a DPT, and a PhD in physical therapy (physiotherapy). She is board-certified by the American Board of Physical Therapy Specialties in women’s health and by the Biofeedback Certification International Alliance in pelvic floor dysfunction. Maher is currently the program director in the Department of Physical Therapy at Philadelphia College of Osteopathic Medicine in Suwanee, Georgia, where she carries out research on the assessment and treatment of pelvic floor dysfunction. She teaches courses on evidence-based practice, research, pain science, women’s health, and musculoskeletal imaging.


This article is for informational purposes only. It is not, nor is it intended to be, a substitute for professional medical advice, diagnosis, or treatment and should never be relied upon for specific medical advice. To the extent that this article features the advice of physicians or medical practitioners, the views expressed are the views of the cited expert and do not necessarily represent the views of goop.