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Minimally invasive device shows promise in treating female urinary incontinence
May 23, 2007A minimally invasive device for treating recurrent stress urinary incontinence in women has been shown to be safe and effective in early clinical trials and is now under review by the U.S. Food and Drug Administration (FDA), says Emory University School of Medicine urologist and trial co-principal investigator Niall Galloway, MD.
Preliminary results from the North American Adjustable Continence Therapy (ACT) clinical study group will be presented today at the annual meeting of the American Urological Association convened in Anaheim, Calif.
The first phase of the multi-center ACT clinical trial, which included Emory, launched in December 2001 and will conclude in June. It tested the device in 160 women diagnosed with stress urinary incontinence who failed to respond to previous treatments.
During the outpatient procedure, which lasts 20-30 minutes, two adjustable balloons are implanted on each side of a patient's urethra. The ACT clinical trial patients on average reported significant continence improvement one year after undergoing treatment. Complications were usually mild.
"The ACT device spells hope for millions of women dealing with incontinence, particularly those who've experienced severe weakness of the urethra muscles," says Dr. Galloway. "Follow up is needed, but the results we have thus far are promising."
It's estimated that 13 million people in the U.S. suffer from incontinence, or loss of bladder or bowel control. At least 85 percent of sufferers are women.
A broad range of conditions and disorders can cause incontinence, including birth defects, pelvic surgery, injuries to the pelvic region or to the spinal cord, neurological diseases, multiple sclerosis, poliomyelitis, infection and degenerative changes associated with aging. It also can occur as a result of pregnancy or childbirth.
The ACT device developed by Uromedica, Inc. may appeal to women seeking a minimally invasive therapy with a shorter recovery time than offered by traditional incontinence surgical treatments, Dr. Galloway says. With ACT, there are no abdominal or vaginal incisions. The balloons can be adjusted post-operatively as needed, eliminating the risk of overtreatment or undertreatment, challenges posed by some existing therapies, he added. The ACT is also reversible. A similar device called ProACT is being tested in men with stress urinary incontinence after prostate surgery.
Emory University
During the outpatient procedure, which lasts 20-30 minutes, two adjustable balloons are implanted on each side of a patient's urethra. The ACT clinical trial patients on average reported significant continence improvement one year after undergoing treatment. Complications were usually mild.
"The ACT device spells hope for millions of women dealing with incontinence, particularly those who've experienced severe weakness of the urethra muscles," says Dr. Galloway. "Follow up is needed, but the results we have thus far are promising."
It's estimated that 13 million people in the U.S. suffer from incontinence, or loss of bladder or bowel control. At least 85 percent of sufferers are women.
A broad range of conditions and disorders can cause incontinence, including birth defects, pelvic surgery, injuries to the pelvic region or to the spinal cord, neurological diseases, multiple sclerosis, poliomyelitis, infection and degenerative changes associated with aging. It also can occur as a result of pregnancy or childbirth.
The ACT device developed by Uromedica, Inc. may appeal to women seeking a minimally invasive therapy with a shorter recovery time than offered by traditional incontinence surgical treatments, Dr. Galloway says. With ACT, there are no abdominal or vaginal incisions. The balloons can be adjusted post-operatively as needed, eliminating the risk of overtreatment or undertreatment, challenges posed by some existing therapies, he added. The ACT is also reversible. A similar device called ProACT is being tested in men with stress urinary incontinence after prostate surgery.
Emory University
Incontinence Current Events and Incontinence News RSSPivotal study for PSD502 -- the first potential treatment for premature ejaculation
At the annual meeting of the Sexual Medicine Society of North America (SMSNA), Inc. in San Diego, Sciele Pharma, Inc., a Shionogi Company and Plethora Solutions Limited, a wholly owned subsidiary of Plethora Solutions Holdings PLC ("Plethora" - AIM:PLE)., today presented data from its second positive pivotal study of PSD502 for the treatment of premature ejaculation (PE).
New finding suggests prostate biopsy is not always necessary
Researchers at Wake Forest University School of Medicine and the University of Wisconsin-Madison have discovered that some elevated prostate-specific antigen (PSA) levels in men may be caused by a hormone normally occurring in the body, and are not necessarily a predictor of the need for a prostate biopsy.
Psychiatric disorders and sexual trauma are associated with lower urinary tract symptoms
Depression, anxiety disorders and sexual trauma have all been implicated as risk factors in lower urinary tract symptoms (LUTS) such as incontinence and overactive bladder.
Pelvic floor muscle exercises can help manage urinary incontinence in older women
Researchers at Rush University Medical Center have found that a program of pelvic floor muscle exercises, combined with pelvic health education, can be an effective way to manage urinary incontinence in elderly women.
UNC expert: Better decision support tools needed for prostate cancer screening choice
Although screening for prostate cancer with the Prostate Specific Antigen (PSA) test in men ages 50-70 can detect the cancer before it becomes symptomatic, knowing whether screening is beneficial for these men is uncertain.
PET/CT scans may help detect recurring prostate cancer earlier
A new study published in the September issue of The Journal of Nuclear Medicine shows that positron emission tomography (PET)/computer tomography (CT) scans with the imaging agent choline could detect recurring prostate cancer sooner than conventional imaging technologies in some patients who have had their prostates surgically removed.
Study finds no link between cognitive decline, socioeconomic status in elderly
New UCLA research suggests that for seniors age 70 and older, socioeconomic status does not play a major role in the brain's continued ability to function.
Study shows seed implants a suitable prostate cancer treatment option for men of all ages
Men diagnosed with prostate cancer have a number of treatments to choose from, but it's a daunting task to figure out the right mix of therapies for an individual patient.
Some neural tube defects in mice linked to enzyme deficiency
Women of childbearing age can reduce the risk of having a child born with a neural tube defect such as spina bifida by eating enough folate or folic acid. However, folate prevents only about 70 percent of these defects.
Uterus sparing surgery is a safe and effective treatment for pelvic organ prolapse
Researchers presented data at the 104th Annual Scientific Meeting of the American Urological Association (AUA) showing that uterus sparing surgery is an effective and safe treatment for women who want to preserve the integrity of vaginal function after pelvic organ prolapse.
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