Frequently Asked Questions

Q: What is another name for the leakage of urine?
A: Urinary incontinence.

Q: What are other words for incontinence?
A: Bladder leaks, pee leaks, wetting yourself

Q: Will FloelleTM work with urinary incontinence?
A: Yes, it works with the most frequent kind of urinary incontinence.

Q: What are the different kinds of incontinence?
A: Urinary incontinence is the unintentional loss of urine and Stress Urinary Incontinence, SUI, is the most frequent kind. Another kind of incontinence is a sudden strong urge to urinate, called Urge Urinary Incontinence, UUI. UUI often occurs along with SUI to form Mixed Urinary Incontinence, MUI.

Q: What is the difference between these types of incontinence?
A: SUI occurs when physical movement or activity — such as coughing, laughing, sneezing, running or heavy lifting — raises the pressure in your belly and creates pressure (stress) on your bladder, causing urine to leak. Stress incontinence is not related to psychological stress. (Source: The Mayo Clinic) About 80 percent of the cases of incontinence are due to stress urinary incontinence, SUI.

Urge Urinary Incontinence, UUI, is caused by twitching of the bladder muscle and can be treated with drugs that relax that muscle (which is why drug companies call UUI “overactive bladder”) or with implanted devices that quiet that twitching.

UUI often occurs along with SUI to form Mixed Urinary Incontinence, MUI.

Q: What causes UUI twitching?
A: The causes of twitching of the bladder muscle are too numerous to list here. For details, please see https://www.webmd.com/urinary-incontinence-oab/bladder-spasms#1-3

Q: Will I have to do anything, once I am wearing FloelleTM?
A: No, just return to your doctor’s office every four months to have the FloelleTM device replaced.

Q: Why do I have to come back in 4 months?
A: The materials we use to make Floelle includes a special chemical that wears out and needs to be replenished.

Q: Why do you need that material and what is it?
A: It is called an antimicrobial and is designed to avoid a buildup of uncomfortable crystals in the urethra. It is widely used in many medical applications.

Q: Why do you need to go to the doctor to get a FloelleTM device?
A: Floelle is available only be prescription from your doctor. It is designed to be inserted by a trained medical professional.

Q: Can I remove the FloelleTM device and insert a new one?
A: No, Only a trained physician should insert or remove the Floelle to avoid pushing it too far into your urethra and possibly causing it to be pushed into your bladder.

Q: Do you need to add any antimicrobial after the device is inserted.
A: No, the device is already made with the antimicrobial as part of the rubber tube and is not added during the insertion procedure.

Q: Is the device insertion painful?
A: No, lidocaine (in the form of a topical liquid) is used to anesthetize the area before the device is inserted. Once the device is in place it usually can’t be felt.

Q: Why do I have to return to the doctor after 4 months?
A: The antimicrobial that is included in the FloelleTM is adequate to last five months; an extra month to provide extra protection should there be a need to return later than expected.

Q: What if I forget, or I cannot arrange, to go to the doctor at that time, and it is longer than 4 months?
A: Enough antimicrobial is in your device to work for five months; this provides extra protection in case you miss your four-month appointment.

Q: How does the FloelleTM device work?
A: The FloelleTM device automatically blocks the leak by sensing a pressure rise in a woman’s abdomen. The pressure rise automatically closes the tubular device’s urine passage.

Once the abdominal pressure returns to normal, the tube automatically reopens, allowing normal urination

Q: Will the device be felt with intercourse?
A: We would need to do a study to know this. We don’t think you could feel it.

Q: Will you feel the device once it’s inserted.
A: Most women who have had the device inserted do not feel the device once it’s in place.

Q: Will I feel the device when I urinate?
A: There should be no sensation when urinating.

Q: Will I be restricted in any way while the device is in place?
A: No, you shouldn’t be restricted from anything while wearing the FloelleTM device.

Q: How do I make sure it will prevent leaks.
A: The device is made to close its urine passage when your abdominal pressure rises above a certain level, thereby preventing leaks. After your doctor inserts the FloelleTM device in your urethra in the office, you will be asked to cough hard several times and the doctor will check that there are no leaks.

Q: What does the FloelleTM device cost?
A: Each kit containing the device and the tools for replacing it costs $667. You will need three of these per year for a total of $2,000.

Q: That seems very expensive. How does it compare to my using absorbent pads or diapers?
A: This is less that the cost of absorbent products, mattress pads, doctor visits to treat dermatitis, skin creams to treat the dermatitis caused by leaking from the absorbent products and dry cleaning of wet clothing.

Q: Will it be covered by my insurance?
A: Once the government assigns a payment code to the kit, it should be covered by insurance.

Q: Will the device fall out?
A: It’s designed to stay in place until removed by your doctor.

Q: But what if it does fall out?
A: If it does fall out it should not cause any harm. You may notice if it does fall out, your incontinence may return and you should contact your doctor to have a new one inserted.

Q: What happens if I miss my appointment?
A: Your doctor will call you to remind you to come to the office to have the device replaced every four months. If you miss your appointment, call your doctor to make a new appointment within the next four weeks. You should be safe until you are scheduled for device replacement.

Q: What to do if I am wearing the device and I still leak.
A: The device may have malfunctioned or may have been inserted incorrectly. If it persists you should return to your doctor’s office to have a new device inserted.