New Study Hopes To Advance Pelvic Floor Dysfunction Treatment

Treatment of pelvic floor dysfunction related issues is what researchers are hoping to advance with new grant contract announced last week. American Medical Systems released a statement on May 12^th revealing the contract which will include six different sites to evaluate two treatments for vaginal prolapse, a common pelvic floor dysfunction in women.

"This pivotal study encompasses a highly scientific-based approach bringing together some of the most respected physicians in the country," said John Nealon, Senior Vice President and General Manager at AMS. "This trial reinforces AMS' commitment to producing high-caliber scientific data, giving physicians the confidence in knowing they have selected the most appropriate technique for treating their patients."

The goal of the study, the statement says, is to fully evaluate the functionality, safety and efficacy of the Anterior Colporrhaphy, Elevate Anterior and Apical Prolapse Repair System. Previous studies have only taken into account vaginal anatomy – not their effects on relieving pelvic floor dysfunction vaginal prolapse.

Researchers expect to begin enrollment of 214 patients for the trials in the later half of 2011. The Mayo Clinic is the main clinic site and there will be four others located around the US and one in Germany.

Current corrective methods for vaginal prolapse include surgical procedures and rehabilitation with pelvic floor physical therapists.

Endometriosis Infertility Diagnostic Device Receives FDA Approval

A diagnostic tool that could help women who are struggling with endometriosis infertility was given approval by the FDA last week – a move that will make this available in all doctors offices.

The device, called the FemVue, is an attachment that fits standard ultrasound machines already available in doctor's offices. Doctors can use the FemVue to quickly and inexpensively perform an ultrasound of a woman's fallopian tubes in the office, without having to refer her elsewhere for standard radiation diagnostics.

Fallopian tube evaluation is typically the first line of diagnostics used when a woman and her partner are having trouble becoming pregnant. An ultrasound image could tell a health care practitioner whether or not the women has any blockage of her tubes due to endometriosis infertility, scarring from infection, or other significant growth. Traditionally, this type of evaluation is done via hysterosalpingography (HSG) which requires a woman to receive a small amount of contrast material trans vaginally while an Xray machine takes images.

Dr. Charles E. Miller, President and Medical Director of the Advanced Gynecologic Surgery Institute, remarked, "I see FemVue as a marked improvement over standard fluoroscopic HSG. It allows me the ability, in the office, to precisely evaluate the cavity, myometrium, and for the first time fallopian tubes. It is my diagnostic procedure of choice for evaluating fallopian tubes."

Endometriosis affects over 5.5 million women in North America. It can cause damage to the ovaries or block the fallopian tubes. Currently endometriosis infertility treatment includes surgery, medications, dietary changes, and assisted reproductive technology techniques.