September 22, 2011 01:00 AM Eastern Daylight Time 

REDWOOD CITY, Calif.–(BUSINESS WIRE)–Gynesonics, Inc., a women’s healthcare company focused on minimally invasive solutions for symptomatic uterine fibroids, today announced the start of, and initial treatments in, the FAST-EU Trial, a multicenter clinical study to demonstrate the effectiveness of the VizAblate® procedure for the treatment of uterine fibroids associated with heavy menstrual bleeding. The VizAblate® System is the only CE marked system that combines ultrasound image guidance with radiofrequency ablation to treat fibroids transcervically in an outpatient setting. Symptoms from uterine fibroids have been reported to affect as many as 24 million women in the European Union.

“The VizAblate® System represents a new and exciting approach to treating fibroids associated with heavy menstrual bleeding and has the potential to be a very important tool for the gynecologist. we are excited to be a part of this study and to have started treatments at our center.”

Centers in the Netherlands, the United Kingdom, and Mexico are participating in the study. Professor Hans Brölmann MD, PhD, Head – Department of Obstetrics and Gynaecology, Vrije Universiteit Medisch Centrum in Amsterdam, Netherlands was the first physician to treat a patient in the FAST-EU study in the European Union. “The VizAblate® System represents a new and exciting approach to treating fibroids associated with heavy menstrual bleeding and has the potential to be a very important tool for the gynecologist. we are excited to be a part of this study and to have started treatments at our center.”

The additional investigators and centers actively recruiting in the study include,

• Marlies Bongers MD, PhD, Gynecologist, Máxima Medisch Centrum, Eindhoven/Veldhoven, The Netherlands
• Jose Gerardo Garza-Leal, MD, Professor of Obstetrics and Gynecology, Hospital Universitario “Dr. José Eleuterio González” de Universidad Autonoma de Nuevo León, Monterrey, Mexico
• Janesh Gupta MSc, MD, FRCOG, Professor of Obstetrics and Gynaecology, Birmingham Women’s Hospital, Birmingham, UK
• Siân E Jones MD, FRCOG, Consultant Obstetrician and Gynaecologist, Department of Obstetrics and Gynaecology, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK
• Sebastiaan Veersema MD, Gynaecologist, Department of Obstetrics and Gynaecology, St. Antonius Ziekenhuis, Nieuwegein, The Netherlands.

Gynesonics is continuing to include additional centers.

The FAST-EU trial has been accepted into the United Kingdom’s National Institute of Health Research Clinical Research Network (NIHR CRN) Portfolio database. Acceptance into the Portfolio is available only for studies perceived as being of high quality and of definite benefit to patients within the National Health Services. “The acceptance of the FAST-EU study into the CRN Portfolio is a testament to the quality of the study design and the potential of the VizAblate® System to positively impact women’s health. we have an outstanding group of clinical investigators and look forward to completing the study and publishing the results,” said Darrin Uecker, President and CEO of Gynesonics.

The most frequent surgical treatment for symptomatic uterine fibroids is hysterectomy, with approximately 250,000 hysterectomies being performed in the United States each year for fibroids. The VizAblate® System offers an alternative procedure designed to treat fibroids individually, sparing the uterus.

The VizAblate® System is currently available for investigational use only in the United States.

Gynesonics, Inc. is a privately-held company with venture capital investors Abingworth, Advanced Technology Ventures, and Interwest Partners. The company has offices in Redwood City, CA.

adasdasdNULL

By: Olinda Rola

Sex after hysterectomy? It’s a real question and concern by women who wonder about their ability and desire for sex after a hysterectomy. the answer is — yes, absolutely! Sex after hysterectomy can be a normal, enjoyable part of a woman’s life. the majority of women following hysterectomy surgery experience either an unchanged sex life or even improved sex after a hysterectomy.

Hysterectomy surgery has advantages and disadvantages. Often the surgery is performed to alleviate discomfort, pain or abnormalities that the woman is experiencing. If you had heavy bleeding, pressure and pain before your hysterectomy, sex after hysterectomy should improve. One change that many women experience during sex after a hysterectomy is that they no longer experience uterine contractions during orgasm. this is not surprising, however, since the uterus has been removed.

According to authors Dr. Scott Goodwin, Dr. Michael Broder and studies by the British Journal of Obstetrics and Gynaecology — if your sex life was good before hysterectomy, sex after a hysterectomy will likely remain the same or even improve after your surgery. in general, hysterectomy should have no adverse effects on your sexuality, provided you are informed of the side effects of hysterectomy and hormone imbalance.

Physically, if your hysterectomy procedure requires the vagina be made shorter, you may experience pain during sex after hysterectomy. To reduce pain due to thisreason, consider being on top during sex to control the level of penetration. Deep penetration may also temporarily cause discomfort in the early months after hysterectomy surgery. this can be overcome by altering the sexual positions or altering the angle of penetration. allow adequate time for the stitches in the vagina to heal, usually about six weeks. Initially, the vagina may seem somewhat shortened, but sex after hysterectomy can gradually stretch the vaginal tissue.

According to family physician and author Dr. John R. Lee, following hysterectomy, you will experience a deficiency of the critical hormones progesterone, estrogen and testosterone which can affect sex after hysterectomy. Progesterone levels fall dramatically in one to two months since ovulation is required to produce progesterone. Progesterone deficiency is related to numerous side effects including increased risk of developing certain kinds of cancer such as endometrial cancer.

Testosterone deficiency in women causes low sex drive, low energy levels, thyroid deficiency and depression. Normal testosterone production requires sufficient progesterone levels in a woman’s body, according to Dr. Lee. And estrogen levels will decrease in one or two years, and estrogen deficiency can result in vaginal dryness, hot flashes and night sweats.

How can you know more about hysterectomy, hormone imbalance and side effects of hysterectomy? there is an online hormone health test provided by a leading women’s health clinic that you can take. the hormone health test takes just a few minutes and is free. Learn as much as you can about hormone imbalance, hysterectomy recovery and physician-recommended natural hormone replacement therapy.

Copyright 2005 InfoSearch Publishing

Read more about hysterectomy and take the hormone health test provided by the womens health clinic online. Olinda Rola is President of InfoSearch Publishing and webmaster of safemenopausesolutions.com – a website of natural health articles and information for women.