If you want to compare pelvic floor devices with non-device options such as physical therapy, bulking injections, pessaries, or surgery, see our complete guide to stress incontinence treatment options.
FDA Clearance and Incontinence Claims
Not all pelvic floor devices are regulated or cleared for the same purpose. A device may be marketed for pelvic floor exercise, wellness, biofeedback, sexual function, or muscle measurement without being FDA-cleared to treat urinary incontinence.
FDA clearance for urinary incontinence means the device has gone through a formal medical-device review process for that specific intended use. The manufacturer must operate under medical-device quality requirements and provide evidence appropriate to the treatment claims being made.
When comparing brands, the most useful distinction is whether urinary incontinence is actually included in the device’s FDA-cleared labeling—not simply whether the company uses terms such as “FDA registered,” “FDA listed,” or “FDA compliant.”
How We Compared These Devices
This comparison looks at more than price or marketing claims. We considered how each device works, whether you perform the contractions yourself or the device activates the muscles for you, internal versus external use, treatment time, privacy and cleaning requirements, FDA-cleared indications, available clinical evidence, typical cost, and overall treatment burden.
Some categories were also evaluated based on hands-on use of representative vaginal trainers and vaginal electrical stimulation devices, along with product labeling, published evidence, pricing, and user reviews.
Stress, Urge, and Mixed Incontinence — Why It Matters
Not all bladder leaks are the same.
- Stress urinary incontinence involves leaks with movement, coughing, sneezing, laughing, or exercise.
- Urge urinary incontinence / overactive bladder (OAB) involves sudden urgency and leakage.
- Mixed urinary incontinence includes both.
Different symptoms may require different therapeutic signals—strengthening in some cases and calming in others. Understanding the type of leakage you experience can help guide treatment choices.
Most pelvic floor exercisers and trainers are designed around strengthening and therefore primarily address stress incontinence. Elitone is designed for stress and mixed incontinence, using strengthening-oriented stimulation together with bladder-calming signals for mixed symptoms. Elitone URGE is designed specifically for urgency and overactive bladder.
Frequently Asked Questions
Do Kegel exercisers treat bladder leaks?
Kegel exercisers can support pelvic floor strengthening, but many rely on voluntary muscle contraction. They may help some people with stress urinary incontinence, but they do not all activate the muscles automatically and they do not treat every type of bladder leakage.
What if Kegels or pelvic floor trainers didn’t work for me?
Difficulty activating weak pelvic floor muscles is common. In these cases, approaches that provide neuromuscular stimulation may help activate the muscles when voluntary contraction is difficult or inconsistent.
Do I need to actively exercise every day for results?
Exercise-based approaches require active participation during each session. Some treatments use electrical or magnetic stimulation to create contractions automatically, which can reduce the amount of active effort required during treatment.
Are internal devices the same as stimulation devices?
No. Some internal devices only measure or coach pelvic floor contractions. Vaginal electrical stimulation devices are different because they actively trigger contractions using electrical signals.
Is there a non-drug option for urgency or overactive bladder?
Yes. In addition to behavioral therapy and medication, non-drug options include bladder-calming electrical stimulation, tibial nerve stimulation, sacral neuromodulation, and external Elitone URGE for OAB.
What if I have both stress leaks and urgency?
This is called mixed urinary incontinence. Treatment may need to address both pelvic floor weakness and bladder overactivity. Elitone is designed to send both strengthening-oriented and bladder-calming signals for mixed symptoms.