Intra-Vaginal Device Helps Improve Pelvic Floor Muscles In Women Living With Pelvic Organ Prolapse
Las Vegas — Results of a clinical study of the Colpexin™ Sphere, a non-pharmacologic, non-surgical therapy for Pelvic Organ Prolapse (POP) and weak pelvic floor musculature, were presented recently at the National Association of Nurse Practitioners in Women's Health (NPWH) 9th Annual Conference at Caesar's Palace in Las Vegas. The data demonstrated the majority of study participants (63%) exhibited increased muscle function with 81.5% of participants exhibiting an improvement in at least one prolapsed vaginal segment at 16 weeks.
"In my practice, women who use the Colpexin Sphere are extremely satisfied. They find it easy to use, have seen improvement in symptoms and increased their pelvic floor strength, sometimes leading to a better sex life," said Diane Smith, MSN, CRNP, presenter and nurse practitioner and continence specialist. "It is a safe and effective non-surgical approach to treating women with POP."
More than 42 percent of adult women in the United States live with POP, a condition caused by the weakening or tearing of the supporting tissue, muscles and ligaments that normally hold the pelvic organs in place. Most cases go untreated, as many women are embarrassed to reveal their symptoms because they do not realize they are treatable. In a 16-week study, the Colpexin Sphere, an intra-vaginal device designed by Adamed, Inc. of Rutherford, NJ (the U.S. subsidiary of the Warsaw-based company of the same name) was found not only to improve pelvic floor muscle strength but also to relieve common symptoms of POP, such as incontinence.
About the Study
A 16-week single-armed study of 27 women with a mean age of 59.2 + 12.9 (range 30 – 79 years) examined primary outcome measures of safety, defined as associated adverse events, and effectiveness, defined as reduction in prolapse and improvement in pelvic floor muscular tone and contractility. Secondary outcome measures were addressed in a patient questionnaire, which included ease of achieving comfort, ease of insertion, ease of removal, sphere position maintenance and satisfaction. Once fitted with the device, pelvic floor exercises were performed twice daily.
A majority of study participants (63%) exhibited increased muscle function with 81.5 percent of participants exhibiting an improvement in at least one prolapsed vaginal segment at 16 weeks. Study participants also exhibited an improvement in pelvic floor muscle contraction strength (p=0.029). No significant differences were observed in resting pelvic tone. Colpexin Sphere also reduced incontinence in women initially reporting leaking (15/20). A majority of the women in the study stated they would recommend the device (92.6%), the device was easy to insert (96.3%) and easy to remove (100%).4
Twenty-three adverse events were reported in the study as possibly/probably related to the intra-vaginal device; however, such events were mild and transient.
About the Colpexin Sphere Intra-Vaginal Device (IVD)
The Colpexin Sphere is an intra-vaginal device designed to treat POP and weakened pelvic floor musculature and enhance the performance of pelvic floor muscle exercises. It is a unique and simple device that gives support to the pelvic organs while strengthening weak pelvic floor muscles.
The Sphere is a smooth, round device that is made from medical-grade plastic, with an applicator for easy insertion and a securely-attached braided nylon string for easy removal. The device is available in five sizes (44, 42, 39, 36 and 32 mm) and must be fitted for each woman based on size and degree of prolapse and the underlying pelvic floor muscle tone. Fitting tools match available sphere sizes. When inserted correctly, it sits within the vaginal canal above the levator musculature. The Colpexin Sphere rarely causes mucosal ulcerations. It takes a dynamic approach to treating POP and requires the patient to perform Kegel exercises twice a day while wearing the sphere in order to strengthen the pelvic floor muscles and support the prolapse.
Colpexin Sphere received 510K approval from the Food and Drug Administration on May 28, 2004.
About Pelvic Organ Prolapse (POP)
Pelvic Organ Prolapse (POP) is a common condition in women in which the pelvic organs (e.g., bladder, uterus and colon) herniate into the vaginal canal resulting in urinary incontinence, lower back pain, a decrease in sexual satisfaction and more. POP affects women of all ages, but it has a particularly strong impact on post-menopausal women, as more than one in three live with the condition. Pregnant women and women who have given birth also have a high likelihood of developing POP. Parous (50% are affected) and aging women are most often affected by POP because the condition often develops in women who are pregnant, have given birth or experienced menopause.
Symptoms of POP include pelvic pressure, a palpable bulge, urinary or fecal incontinence and sexual dysfunction. The condition is caused by a variety of factors, including pregnancy and childbirth, obesity, genetic predisposition, hysterectomy and estrogen deprivation (such as experienced after menopause).
Pelvic organ prolapse can be a devastating condition for women, dramatically impacting important aspects of a women's life from her ability to perform daily activities to her self-image and sense of control. Women living with POP can experience decreased sexual activity, decreased social interaction, decreased exercise due to worries of loss of bladder/bowel control, urinary tract infections due to urinary retention and bowel impaction due to chronic constipation.
Currently, nearly 400,000 women undergo surgical procedures to treat POP. Surgery is not always effective, however, as one in three procedures are repeats of earlier operations.3 Non-surgical options for the treatment of POP will become increasingly necessary over the next 30 years, as the number of women needing relief from POP symptoms is expected to increase by 38 percent—proportionally equivalent to the US Census Bureau's 2004 Interim Projections of an increase in the number of women ages 45-84.2
SOURCE: Adamed Inc.