a woman inserts the FemSoft Insert, the soft sleeve glides into the urethra, creating a soft seal at the bladder neck to prevent unintended urine leakage. A small tab that remains outside the urethra is used to remove the insert.

The FemSoft Insert is a small, single-use, liquid and silicone product that is inserted into the urethra. The FemSoft Insert 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.

The FemSoft Insert is a new option for the non-surgical management of female stress urinary incontinence (SUI). Results of clinical studies indicate that the FemSoft Insert is a viable option for women with mild to severe SUI due to urethral hypermobility or intrinsic sphincter deficiency (ISD).

Have a history of urethral stricture, bladder augmentation, pelvic radiation, or other anatomic or pathologic conditions where passage of a catheter through the urethra is not clinically advisable. Are immuno-compromised, have a prosthetic heart valve or other implanted device, or have any other conditions in which the patient is at significant risk from urinary tract infection. Have interstitial cystitis, pyelonephritis, or a history of severely compromised urinary tract mucosal tissue.

Some women may need to use the FemSoft Insert every day to control incontinence, while others may need it only for very specific activities. Most women found the insert easy to use once they were comfortable and confident with insertion.

The FDA restricts this device to sale by or on the order of a physician trained in the management of urinary incontinence. Clinicians who subsequently have been trained in the use of the FemSoft Insert will be registered with the FemSoft Resource Center and able to prescribe the device.

Rochester Medical provides a complimentary Clinic Sizing and Training kit to each clinic that is presenting the FemSoft Insert to female patients. This kit includes sterile samples of each available FemSoft Insert size, as well as other training and support materials for use with the women seen in your practice.

Physician Services: Insurance plans generally cover physician's fees for the initial evaluation and training on the use of the FemSoft Insert, as well as follow-up visits. The physician's office will customarily file a claim with a woman's insurance plan on her behalf. As always, a woman is responsible for any co-pay or deductibles that may apply under the terms of her health plan.

The FemSoft Insert must be removed and discarded each time you empty your bladder. Even if you do not need to urinate, the insert must be replaced at least every six hours. The FemSoft Insert must also be removed at night for sleep.

The FemSoft Insert 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 the FemSoft Insert during activities as aggressive as aerobics and kickboxing. Women also have comfortably used it during horseback riding. The FemSoft Insert is not for use during sexual intercourse.

The FemSoft Insert is only available by prescription and requires an evaluation by a health care provider trained in the use of the FemSoft Insert. this early stage of its commercial availability, the FemSoft Insert is available through clinics in several states. To find out if it is available in your area at this time, visit the How do I get it? page. If you don't see your area listed, contact us.

You can find a list of participating clinic locations on the How do I get it? page. If you don't see a clinic listed for your area, contact us. We will be happy to add your name and mailing address to our database, so you can be notified as the product becomes available in your area.

examination is required for proper evaluation and diagnosis of each woman's type and severity of urinary incontinence. Additionally, when a woman begins using the FemSoft Insert, she is evaluated for the proper size of insert and is instructed on the correct application and use of the product.

Because the FemSoft Insert can only be sold by prescription, samples of the product are only available during your appointment with the doctor who is evaluating your incontinence.

Physician Services: Your insurance plan generally will cover your doctor's fees for your initial evaluation and training on the use of the FemSoft Insert, as well as your follow-up visits. Your doctor's office will customarily file a claim with your insurance plan on your behalf. As always, you are responsible for any co-pay or deductibles that may apply under the terms of your health plan.

The FemSoft Insert is available in six configurations, including three diameter sizes with two lengths in each size. The sizing process, done in the physician's office, follows a simple decision tree:

Prophylactic antibiotics were not used during the FemSoft Insert clinical study. However, physicians should evaluate each patient individually to determine what treatment is indicated for a specific patient. Additionally, to reduce the risk of UTI women are advised to: The risk of adverse events is further minimized by appropriate patient education, training and monitoring by health care professionals.

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 the FemSoft Insert. 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.

this early phase of the FemSoft Insert's commercial availability, it is only being marketed in limited areas of the U.S. If you don't see your area listed on the How do I get it? page, contact us. We will be happy to add your name and mailing address to our database, so you can be notified as the product becomes available in your area.

In order to ensure that a woman is an appropriate candidate for using the FemSoft Insert, a doctor's examination and prescription are required. Because the FemSoft Insert is new to the marketplace, it is not yet feasible to place the product in the numerous traditional pharmacy outlets across the country. Instead, once you have received the required prescription for the FemSoft Insert, you will be provided a toll-free number for ordering the product.

According to the Agency for Health Care Policy and Research guidelines, the following tests are recommended as a minimal evaluation prior to initiating SUI treatment:

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The Insert Cleaner is used to remove shell wrap that forms around the inserts over time. With the accumulation of shell wrap, the inserts either won't turn or will loose their peeling power due to lack of friction. The Insert Cleaner is used most readily in the cold water market where shell wrap is more commonly found. The Insert Cleaner is a frame with several rows of spray nozzles that moves across the peeling bed spraying high-pressure water down onto the inserts.