WHAT TO KNOW
Urinary incontinence affects millions of women and can cause bladder leaks during activities like coughing, laughing, sneezing, or exercise, as well as sudden urges to urinate that are difficult to control. While common, urinary incontinence is not a normal part of aging and can often be improved with appropriate treatment.
First-line treatment options typically include pelvic floor muscle training, bladder retraining, and lifestyle modifications. The Leva® Pelvic Health System is an FDA-cleared, non-invasive pelvic floor training device that combines guided exercises with real-time biofeedback through a smartphone app. Designed for at-home use, Leva helps women strengthen their pelvic floor muscles, improve bladder control, and reduce leakage episodes without surgery or medication. Talk with your healthcare provider to determine whether Leva may be an appropriate treatment option for your symptoms.
WHAT IS URINARY INCONTINENCE?
Urinary incontinence (UI) is the unintentional loss of bladder control, resulting in the leakage of urine. It can range from occasional dribbling when coughing or sneezing to a sudden, strong urge to urinate that prevents reaching a restroom in time. Commonly affecting older adults, urinary incontinence can occur in both men and women due to various causes, including weakened pelvic muscles, medical conditions, or certain medications.
It can be uncomfortable and sometimes embarrassing, urinary incontinence is a treatable condition with lifestyle changes, medical therapies, and interventions designed to restore bladder control and improve quality of life.
UI CAN BE VERY ISOLATING
Feeling alone with urinary incontinence is a common yet deeply isolating experience for many individuals. Despite the fact that millions of people struggle with bladder control issues, the stigma and embarrassment surrounding the condition often prevent open discussions or seeking help. This silence can create a sense of isolation, making those affected feel as though they are facing the challenges alone. The physical inconvenience of incontinence is often compounded by emotional distress, such as shame, anxiety, and a reluctance to participate in social activities. However, understanding that urinary incontinence is a common and treatable condition can be the first step toward breaking the isolation and regaining confidence.
NON-INVASIVE APPROACHES TO TREATING UI
First-line therapies for urinary incontinence beyond lifestyle medications focus on non-invasive approaches that aim to strengthen the pelvic floor and improve bladder control. These include pelvic floor muscle exercises, also known as Kegels, which help build the muscles that support the bladder.
A pelvic floor strengthener is a tool or device designed to help individuals strengthen the muscles of their pelvic floor, which support the bladder, uterus, and bowel. These muscles play a critical role in maintaining bladder and bowel control, as well as in sexual health. Pelvic floor strengtheners typically work by providing resistance or biofeedback during exercises, encouraging correct muscle engagement. Common types include vaginal weights, biofeedback devices, and app-connected tools like the Leva Pelvic Health System. These devices are often used alongside pelvic floor exercises to improve muscle tone and function, making them an effective solution for issues like urinary incontinence or pelvic organ prolapse.
THE LEVA® PELVIC HEALTH SYSTEM
The Leva® Pelvic Health System is an innovative, FDA-cleared device designed to help individuals strengthen their pelvic floor muscles and address issues like urinary incontinence. It combines a small, sensor-equipped vaginal insert with a smartphone app to provide real-time biofeedback and guided pelvic floor muscle exercises. Unlike traditional methods, Leva’s system uses motion-sensing technology to help users visualize their pelvic floor movements and improve exercise accuracy. This personalized, at-home training is non-invasive and can be completed in just a few minutes daily, making it a convenient and effective option for those seeking to regain bladder control and improve overall pelvic health.
Key advantages include:
- Non-Invasive Treatment: The system provides a safe, non-surgical option for addressing urinary incontinence, avoiding the risks associated with invasive procedures.
- Real-Time Biofeedback: Leva’s motion-sensing technology gives users instant visual feedback on their pelvic floor movements, helping them perform exercises correctly and effectively.
- Convenience: The system is designed for at-home use, requiring only a few minutes of daily exercise, making it a practical option for busy lifestyles.
- FDA-Cleared: Leva is FDA-cleared for treating stress, mixed, and mild-to-moderate urgency urinary incontinence, ensuring its safety and efficacy.
- Improved Muscle Strength: By promoting proper exercise technique, the system helps users build stronger pelvic floor muscles, leading to better bladder control and overall pelvic health.
- Customized Support: The accompanying smartphone app provides guidance and tracks progress, creating a tailored experience for each user.
- Increased Confidence: Strengthening the pelvic floor can reduce leakage episodes, empowering users to regain control over their daily lives and participate in activities without fear or embarrassment.
In an 8-week clinical study, Leva users saw a decrease in leaking episodes from nearly 2 leaks per day to 2 week per week. In addition, 78% of Leva users see significant improvement.
Leva Coaches remotely monitor patients’ therapy to provide individualized support and are available as much or as little as you want. Leva is positioned to provide your you with a safe space to discuss your pelvic health, ask questions and share your experience. In This video, a Leva coach shares some of the heartbreaking stories of patients she has worked with supporting them through their journey to relief.
Talk with your doctor about The Leva Pelvic Health System as an effective, non-invasive treatment for urinary incontinence. Open communication about symptoms and goals allows your doctor to assess whether Leva is an appropriate option for you.
Important Safety Information for Leva Pelvic Health System:
The Leva Pelvic Health System is intended for: (1) strengthening of pelvic floor muscles, (2) rehabilitation and training of weak pelvic floor muscles for the treatment of stress, mixed, and mild to moderate urgency urinary incontinence (including overactive bladder) in women and (3) rehabilitation and training of weak pelvic floor muscles for the first-line treatment of chronic fecal incontinence (>3-month uncontrolled passage of feces) in women. Treatment with the Leva System is by prescription and is not for everyone. Please talk to your prescriber to see if Leva System is right for you. Your prescriber should discuss all potential benefits and risks with you. Do not use Leva System while pregnant, or if you think you may be pregnant, unless authorized by your doctor. For a complete summary of the risks and instructions for the Leva System, see its Instructions for Use available at www.Levatherapy.com.
Disclaimer Regarding Patient Testimonials:
Testimonials are collected or recorded via surveys, emails and interviews and reflect real-life experiences from real patients. However, each individual’s results will vary and included testimonials are not intended to represent or guarantee that any one patient will achieve the same or similar results. Please also note that some patients may be paid for their testimonials.
Frequently Asked Questions About the Leva® Pelvic Health System
What is the Leva® Pelvic Health System?
The Leva® Pelvic Health System is an FDA-cleared, prescription digital therapeutic that helps women strengthen their pelvic floor muscles through guided exercises and real-time motion-based biofeedback delivered through a smartphone app.
How does Leva help treat urinary incontinence?
Leva helps users perform pelvic floor muscle exercises correctly, which can improve muscle strength, support bladder control, and reduce urinary leakage over time.
What types of urinary incontinence can Leva treat?
Leva is FDA-cleared for the treatment of stress urinary incontinence, mixed urinary incontinence, and mild-to-moderate urgency urinary incontinence, including overactive bladder symptoms.
Is Leva a non-surgical treatment option?
Yes. Leva is a non-invasive treatment that can be used at home and does not require surgery, injections, or implanted devices.
How does Leva differ from traditional Kegel exercises?
Leva provides real-time biofeedback that helps users visualize their pelvic floor muscle movements and confirm they are performing exercises correctly, something that can be difficult to achieve with Kegels alone.
Do I need a prescription for Leva?
Yes. The Leva Pelvic Health System is available by prescription and should be discussed with a healthcare provider to determine if it is appropriate for your symptoms.
How long does it take to see results with Leva?
Results vary by individual, but clinical studies have shown significant improvements in leakage episodes after consistent use over several weeks.
Can I use Leva at home?
Yes. Leva is designed for convenient at-home use and pairs with a smartphone app that guides exercises, tracks progress, and provides personalized feedback.
Is Leva covered by insurance?
Coverage may vary by insurance plan. Patients should check with their healthcare provider and insurance company regarding eligibility and coverage options.
Who may be a good candidate for Leva?
Women experiencing stress, mixed, or mild-to-moderate urgency urinary incontinence who are looking for a non-invasive treatment option may benefit from discussing Leva with their healthcare provider.
Sources:
- Weinstein MM, Dunivan G, Guaderrama NM, Richter HE. Digital Therapeutic Device for Urinary Incontinence: A Randomized Controlled Trial. Obstet Gynecol. 2022;139(4):606-615. doi:10.1097/AOG.0000000000004725.
- Weinstein MM, Dunivan GC, Guaderrama NM, Richter HE. A Motion-based Device Urinary Incontinence Treatment: A Longitudinal Analysis at 18 and 24 Months. Int Urogynecol J. Published online January 22, 2024. doi:10.1007/s00192-023-05721-z.
- Keyser LE, McKinney JL, Pulliam SJ, Weinstein MM. A digital health program for treatment of urinary incontinence: retrospective review of real-world user data. Int Urogynecol J. 2023;34(5):1083-1089. doi:10.1007/s00192-022-05321-3.
One Response
Any devices like this for men with UI & OAB?