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External Non-Latex, Texas Catheters, External Catheters, Male Catheters, Condom Catheters.
FemSoft
A new self-inserted device that stops urine leakage, FemSoft is indicated for the treatment of stress urinary incontinence. FemSoft is a product of Rochester Medical Corp, Stewartville, MN.
FemSoft is a single-use liquid and silicone device that a woman can insert into her urethra. The latex-free insert consists of a narrow silicone tube completely encapsulated by a soft, conformable, fluidfilled sleeve. As a woman inserts the device, the sleeve slides into and conforms to the urethra, creating an effective seal at the neck of the bladder to prevent urine leakage. It is removed during routine bathroom visits, discarded, and replaced by a fresh insert.
FemSoft is sold by prescription, and the manufacturer provides a toll-free number for orders, which are discreetly packaged and shipped. Because the product is available in different sizes, it must first be sized by a health care provider.
NeoControl Pelvic Floor Therapy System
The NeoControl Pelvic Floor Therapy System from Neotonus, Marietta, GA, uses a technology called Extracorporeal Magnetic Innervation (ExMI) to restore continence by strengthening the pelvic floor muscles that affect bladder control. ExMI, developed by Neotonus in 1997 in collaboration with Emory University School of Medicine and the Georgia Institute of Technology, was cleared by the Food and Drug Administration in June 1998 for the treatment of stress, urge, and mixed urinary incontinence in women.
The first commercial product to utilize ExMI technology, the NeoControl Pelvic Floor Therapy System uses powerful pulsing magnetic fields to stimulate nerve activity in the pelvic floor. In turn, the muscles that control bladder function are exercised, improving strength and endurance and increasing circulation. While remaining fully clothed, a patient undergoes a painless, noninvasive 20minute treatment twice a week for 8 weeks.
Data from studies at sites in Cleveland, OH, Chicago, IL, Philadelphia, PA, and Orlando, FL, indicate that 50% of women who completed 6 weeks of NeoControl therapy reported being"completely dry" and an additional 30% reported"significant improvement"in their condition. Clear Advantage, External Non-Latex, Freedom Clear, Latex-free external catheters, UltraFlex Self-adhering Catheter
InterStim Therapy for Urinary Control
Medtronic's InterStim Therapy for Urinary Control uses electrical stimulation of the sacral nerve to treat urinary urge incontinence, urine retention, and significant symptoms of urgency-frequency. In InterStim Therapy, the sacral nerves, which control the behavior of the bladder, sphincter, and pelvic floor muscles, are stimulated via a lead that is implanted adjacent to the sacral nerve. An extension connects the lead to a neurostimulator (about the size of a stopwatch), which is typically implanted under the skin of the lower abdomen.
Clinical studies have shown InterStim Therapy to be effective. After 12 months of InterStim Therapy, 82% of urgencyfrequency patients voided increased volumes of urine with the same or a reduced degree of urgency, meaning they felt urgency only when their bladders needed to be emptied, rather than continually. After 6 months, 47% of patients with urinary urge incontinence were completely dry, and 77% reported that they no longer experienced unexpected, heavy wetting episodes. In addition, 53% of patients with urine retention no longer needed a catheter. A report in the June issue of the Journal of Urology supports the use of InterStim Therapy in the treatment of urgency-frequency.
Treatment with InterStim Therapy involves 3 steps: test stimulation, surgical implant, and postimplant follow-up.
Test stimulation. The physician and patient can assess the effectiveness of InterStim Therapy in controlling symptoms through a diagnostic trial conducted over several days. If symptoms improve during the test stimulation period, the physician and patient determine whether to pursue InterStim Therapy as a long-term treatment.
Surgical implant. If the test stimulation is successful, the neurostimulator is implanted under the skin in the lower abdomen. A small surgical opening is made over the sacrum and a lead is placed near the sacral nerve that influences bladder control. The other end of the lead is passed under the skin and connected to the neurostimulator.
Postimplant follow-up. Following implant, the neurostimulator is activated. The neurostimulator sends mild electrical pulses via the lead to the sacral nerve. Adjustments to stimulation can be made to optimize the therapy.
The first direct-to-consumer pelvic muscle training aid to help women improve symptoms of urinary incontinence, fria was recently cleared for marketing by the Food and Drug Administration.
Women are especially at risk for urinary incontinence because of pelvic floor weakness resulting from childbirth and menopause. Strengthening the pelvic floor has been clinically shown to improve continence in most women: In one clinical study, 79% of participants had significant improvement from stress and urge incontinence. The fria system guides the user through the pelvic muscle exercises that will strengthen the pelvic floor and gives immediate feedback on the effectiveness, strength, and duration of muscle contractions.
Designed as a cost-effective alternative to surgery, pharmaceuticals, and adult absorbent products, fria is based on the award-winning"Persist Treatment System" from DesChutes Medical Products, Bend, OR. fria will initially be marketed in catalogs and on Web sites with the following direct consumer health product sources.
PerQ SANS
The Percutaneous Stoller Afferent Nerve Stimulation System (PerQ SANS) from UroSurge Corp, Coralville, IA, has been approved by the Food and Drug Administration for the treatment of urge incontinence and urinary urgency-frequency.
PerQ SANS therapy, which can be performed in the health care provider's office, uses low-frequency electrical stimulation of the sacral region of the spine to retrain the nerves controlling the bladder. Studies have shown that the S3 region of the spinal cord plays a key role in the neurologic control of bladder function. Of the nerves that eminate from the S3 junction, the posterior tibial nerve runs all the way down the leg to the foot. The anatomy of the ankle area provides an easy access point to the posterior tibial nerve. The current is introduced through a fine-gauge needle.
Incontinence can be a problem in longterm-care (LTC) facilities: Government statistics show that 50% of elderly people living at home or in LTC facilities are incontinent. The challenge for staff in the LTC setting is to know how often patients should be toileted-and whether their bladders are really empty after toileting.
The BladderScan BVI 3000 from Diagnostic Ultrasound Corp can help. A portable, noninvasive ultrasound device, the BladderScan allows the user to quickly determine bladder volume. This information is crucial for making decisions about the care of residents with urinary incontinence or urine retention. The results of the scan tell the staff whether:
it is time to get the resident up for toi leting, allowing for individualized toileting programs and preventing unneeded trips to the bathroom
the resident has completely voided, an important facet of a bladder retraining program
the resident really needs to be catheterized, avoiding unnecessary procedures that could put the resident at risk for a urinary tract infection.
Detrol Tablets
Detrol Tablets (tolterodine tartrate tablets), marketed by Pharmacia & Upjohn, are indicated for the treatment of overactive bladder. Overactive bladder is a result of abnormal, uncontrolled contractions of the detrusor muscle (the major muscle controlling the bladder) during bladder filling, causing symptoms of frequency, urgency, or urge incontinence that can interrupt work, daily activities, and sleep. Detrol works by helping to block contractions of the detrusor muscle.
Introduced in April 1998, Detrol is now the most widely prescribed medication for overactive bladder in the United States. In a 12-week clinical study, patients taking Detrol made 20% fewer trips to the bathroom (about 2 times less in a 24-hour period); patients taking a placebo made 10% fewer trips (about 1 time less). Prior to treatment, patients had reported going to the bathroom an average of more than 10 times in a 24-hour period. The decrease in wetting accidents was similar with Detrol and placebo over a 24-hour period.
Overall, the percentage of patients reporting adverse events with Detrol was comparable to placebo. Reported treatment-related adverse effects of Detrol included dry mouth, headache, constipation, indigestion, and dry eyes.
Uroclean
This new latex-free system, distributed by Uroclean of Georgia, Inc, Jesup, GA, offers men who are incontinent of urine an alternative to external catheters. The system is reusable and does not require the use of adhesives, tapes, or condoms.
The leak-free, odor-free Uroclean system includes a sheath, sealing sleeve, briefs, hip belt, and urine receptacle with leg straps. Using an application aid included with the system, the sealing sleeve is placed over the sheath to do what its name implies-provide a seal so that urine cannot leak from the sheath. The sheath is then placed over the penis. Depending on the man's preference, either a brief or a hip belt is used to secure the sheath with hook-andloop closure. The sheath is attached to the leg bag with a flexible hose. A rinsing aperture on the sheath is covered with a stopper and opened only to instill 10 mL of water or a cleansing solution as needed.
The manufacturer recommends that the sheath be removed every 12 hours, the skin of the penis cleaned, then a new sheath applied. The used sheath can be washed by hand or in the washing machine; it can also be placed in the clothes dryer.
Clear Advantage, External Non-Latex, Freedom Clear, Latex-free external catheters, UltraFlex Self-adhering Catheter.