Consumer
FAQ
Q: What is FemSoft?
A: FemSoft is a disposable, single-use product available by prescription. A woman simply inserts the soft, sterile product
into her urethra to prevent unintentional urine leakage. It’s so comfortable women report they hardly know it’s there.
Most importantly, it provides immediate control over wetness and odor without surgery.
FemSoft is designed to prevent urine leakage during daily activities in adult women with stress urinary incontinence
(SUI). SUI is the involuntary loss of urine caused by pressure on the bladder from everyday activities as common as
laughing, sneezing, coughing, lifting a bag of groceries, rising from a sitting position, or exercising.
Q: How can I find out if I have stress urinary incontinence?
A: Tell your healthcare provider about your unintentional urine leakage. He or she will talk with you about your medical
history and urinary habits. You will have a physical examination and urine tests. You may be asked to keep a record of
your usual bathroom habits. You also may have other tests to find the exact cause of your incontinence and the best
treatment for you.
Q: How does FemSoft work?
A: As a woman places FemSoft into her body, the soft sleeve glides into the urethra and creates a soft seal at the bladder
neck. The insert conforms instantly to her individual shape to prevent accidental leakage. It’s so comfortable women
report they hardly know it’s there. When a woman using FemSoft is ready to urinate, she uses the small tab that remains
outside the urethra to simply remove the insert.
Q: What is FemSoft made of?
A: The latex-free FemSoft Insert is made entirely of silicone and mineral oil. It consists of a narrow silicone tube entirely
encased in a soft, thin, mineral oil-filled sleeve. The sleeve, also silicone, forms a balloon at the internal tip and a soft,
oval-shaped external retainer at the opposite end. A disposable applicator is used for insertion.
Q: How big is FemSoft?
A: FemSoft is available in several sizes to provide a proper fit. Each is approximately 1½ to 2 inches in length.
Q: Can I use FemSoft?
A: A clinical study of 150 stress incontinent women was performed at eight clinical centers in the United States. FemSoft
was effective in controlling urine loss for women with these characteristics:
• Mild to severe stress urinary incontinence (SUI)
• SUI due to weak pelvic floor muscles
• SUI due to weak muscles around the urethra
• Unsuccessful incontinence surgery or other incontinence treatments
• Mixed stress and urge incontinence
• Single, multiple or no childbirths
• Pre- and post-menopausal
• All ages
Your healthcare provider will let you know if FemSoft is right for you. Because every woman’s body is different,
everyone who uses FemSoft must first be evaluated by a trained clinician and fitted with the correct size of insert.
You’ll then receive a prescription for the product along with specific directions for using FemSoft.
Consumer
FAQ
Q: How do I use FemSoft?
A: FemSoft is simple and gentle to use. Your healthcare provider or clinic staff will teach you how to insert and remove it.
You should expect that it will take 1 to 2 weeks to become confident using FemSoft on your own, depending on your
frequency of use. Be patient with yourself while learning to use FemSoft.
• Use FemSoft during the day when protection is needed from leakage.
• Remove FemSoft when you need to urinate. Use a new FemSoft after urination.
• Remove FemSoft, empty your bladder, and replace with a new insert at least once every 6 hours.
• Remove the insert at night for sleep.
• FemSoft is not intended to prevent normal urination.
Q: Why do I need to use a new, sterile FemSoft each time?
A: To reduce the risk of a urinary tract infection.
Q: For what activities may I use FemSoft?
A: FemSoft may be used during any activity that increases pressure on the bladder and causes unintentional urine
leakage. Examples of these activities include social gatherings, household chores, sporting activities, and hobbies.
Women have reported using FemSoft during activities as aggressive as aerobics and kickboxing. Women also have
comfortably used it during horseback riding.
Q: What kind of problems can you have using FemSoft?
A. No serious problems have been reported. The most commonly occurring problem is urinary tract infection or bacteria
in the urine. Sometimes new users experience a small amount of spotting or blood in the urine caused by irritation
while learning to use FemSoft. Other potential problems may include: urinary frequency, pain or burning during
urination, inability to retain the insert, or movement of the insert into the bladder. If you experience any of these
symptoms, stop using FemSoft and call your clinician.
Q: Can I use FemSoft if I am allergic to latex?
A: Yes. FemSoft is completely latex-free. The insert is made of silicone and mineral oil.
Q: How do I get/buy FemSoft?
A: FemSoft is only available by prescription and requires an evaluation by a healthcare provider trained in the use of
FemSoft. Once you have received a prescription for FemSoft, you will be provided a toll-free number for ordering the
product. Your order will then be conveniently and discreetly shipped to the address you provide.
Q: Why do I have to get FemSoft through a doctor or other prescribing clinician?
A: An examination is required for proper evaluation and diagnosis of each woman’s type and severity of urinary
incontinence. Additionally, when a woman begins using FemSoft, she is evaluated for the proper size of insert and is
instructed on correctly using the product.
Consumer
FAQ
Q: How is FemSoft packaged?
A: Each FemSoft comes in a sterile, single-use package that fits discreetly in a purse or pocket. FemSoft is supplied ready
to use, on a disposable applicator and with lubricating gel. FemSoft is packaged in boxes of 28 inserts of one size.
Q: Can I get a sample of FemSoft?
A: Because FemSoft must be sold by prescription, samples of the product are only available during your appointment
with a clinician.