Ulipristal Acetate effectively controls uterine bleeding in patients with symptomatic uterine leiomyomas

Nearly 50% of women with symptomatic uterine fibroid achieved amenorrhea with Ulipristal Acetate as compared to placebo, reports the results of small randomized control trial published in March issue of Journal of Obstetrics and Gynecology.

Leiomyomas are the most common indication for hysterectomy in the United States affecting nearly 70% of white women and more than 80% of black women of reproductive age. About a quarter or 50% of women experience symptoms, the most common being heavy and irregular uterine bleeding.

Many medical treatment options like nonsteroidal anti-inflammatory drugs (NSAIDs), levonorgestrel intrauterine devices, and oral and nonoral combination contraceptives are prescribed in the treatment of symptomatic fibroids but data about their efficacy is limited.

Other off-label drugs that are used for short-term management include gonadotropin-releasing hormone agonists and tranexamic acid.

This multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel-group phase 3, (NCT02147197) was conducted at 25 study centers across the United States.

Premenopausal women between 18-50 years of age with one or more discrete leiomyomas and uterine size 20 weeks of gestation with menorrhagia were included in the study. The researchers looked at the rate of and time to amenorrhea (no bleeding for the last 35 consecutive days of treatment) as the co-primary endpoints and Uterine Fibroid Symptoms and Quality of life (QoL) as the secondary endpoints.

Over a period of 2 years, 157 patients with similar demographics were randomized 1:1:1 to once-daily oral 5 mg ulipristal, 10 mg ulipristal, or placebo followed by a 12-week drug-free period.

Patients fared significantly better with both the doses of ulipristal, in terms of achieving amenorrhea 25 of 53 (47.2%) and 28 of 48 (58.3%) patients treated with 5 mg and 10 mg ulipristal, respectively achieved amenorrhea as compared with 1 of 56 (1.8%) of placebo-treated patients (both P <.001).

Patients on ulipristal also reported an improved quality of life and a decrease in the amount of blood loss. At the end of follow-up period decrease in volume of the leiomyomas was also observed in ulipristal treated groups as compared to placebo where an increase was noted.  

The small sample size and short duration of treatment were not enough to study the side effects but not a single patient discontinued the treatment because of side effects of the drug.

Other studies have shown that multiple 12-weeks courses of ulipristal (up to 8 coursed of 12 weeks duration each) is effective and well tolerated and maintains the efficacy and quality of life.

The authors concluded, “ulipristal may be useful for the medical management of abnormal uterine bleeding associated with uterine leiomyomas, especially for patients desiring uterine- and fertility-sparing treatment.”

Abstract

Full text

Media Courtesy: YouTube and helloclue.com

Ob/Gyn Updated FaceBook page

Hologic, Inc launched MyoSure MANUAL, for in-office intrauterine tissue removal

Hologic, Inc today expanded its Myosure portfolio by adding the MyoSure MANUAL device which enables physicians to more easily resect and remove intrauterine polyps and fibroids in office settings when used along with the MyoSure hysteroscope.

The device comes with an ergonomically designed blade that can be rotated through 360 degrees, enabling wide range of smooth motion. The system does not require cauterization and have a transparent tissue trap that allows the physician to see the specimen and can holds up to 4gms of tissue.

The tissue trap can be detached, and the specimen can be sent for direct histopathological examination.

In addition, the system also comes with a built-in vacuum, eliminating the need of external suction and works with a one-liter saline bag. 

The complete MyoSure system is a minimally invasive hysteroscopic treatment for women with Abnormal Uterine Bleeding (AUB) due to polyps or fibroids and requires no cauterization, which preserves uterine form and function.

Edward Evantash, M.D., Medical Director and Vice President of Medical Affairs, Hologic said in a press release, “We recognize the increased demand for in-office procedures, and seek to develop innovative solutions to provide flexibility and convenience for both physicians and patients. The MyoSure MANUAL device was designed for in-office tissue removal procedures, requiring minimal setup and no vacuum or fluid management system, while offering direct visualization when used with the MyoSure hysteroscope."

 “The MyoSure MANUAL device is an exciting addition to Hologic's growing portfolio of gynecologic solutions, developed with the patient and physician in mind. This addition to the MyoSure product suite signals our ongoing commitment to providing effective surgical solutions that can be performed in office to address our customers' needs and improve the overall patient experience," added Sean Daugherty, President of GYN Surgical Solutions at Hologic.

Contraindications for the use of MyoSure MANUAL Tissue Removal Device includes  pregnancy or suspected pregnancy, has clinical evidence of an active pelvic infection or history of a recent pelvic infection, or has cervical malignancies or previously diagnosed uterine cancer.

Other devices in Myosure Portfolio include MyoSure^®, MyoSure^® REACH, MyoSure^® XL, and MyoSure^®LITE devices.

Complete MyoSure MANUAL device Instructions for use

Press Release

Follow on Facebook and Twitter.

Cerene cryotherapy device for Endometrial ablation cleared for European market

ChannelMedsystems, the makers of Cerene cryotherapy endometrial ablation device today won the CE mark approval in the European union. The company is based at San Francisco, California, and the device is designed to treat premenopausal women with heavy menstrual bleeding who do not desire further pregnancies.

The Cerene Cryotherapy Device uses nitrous oxide, that freezes and destroy the surrounding endometrial tissue, thereby reducing scarring and intrauterine adhesions that are often associated with heat-based treatments.

Scarring and adhesions often lead to failure of procedure and reoperation. The cryothermic delivery system was incorporated into disposable, ergonomic device that can be held by hands thereby eliminating bulky equipments.

Earlier, in March 2017, Channel Medsystems, announced the successful completion of the treatment phase in its CLARITY Pivotal Study. The pivotal study evaluated the safety and efficacy of Cerene® Cryotherapy Device in 242 women with heavy menstrual bleeding who have already completed the family.

Ric Cote, President and CEO of Channel Medsystems said in a newsletter, ““From inception, our team has worked to understand what women and gynecologists are seeking in a new treatment for heavy menstrual bleeding. We’ve integrated that feedback into our development process and are excited that women in Europe will now have access to a treatment that is intended to meet their unique needs.”

“The introduction of the Cerene procedure in Europe will allow gynecologists to provide a new treatment option to their patients, one that may become more routine because it is designed to be more comfortable than traditional endometrial ablations, even without IV sedation or general anesthesia,” he further added.

Channel Medsystems endometrial cryoablation procedure animation video

Channel Medsystems completes pivotal study of Cerene® Cryotherapy Device for successful office based Endometrial ablation.

Cerene® Cryotherapy Device screenshot 

Channel Medsystems, a company based at Emeryville, CA announced the successful completion of the treatment phase in its CLARITY Pivotal Study. The pivotal study evaluated the safety and efficacy of Cerene® Cryotherapy Device in 242 women with heavy menstrual bleeding who have already completed the family.

Clarity study was a multisite study involving 8 locations in US along with few international locations. The study recruited its first participant in October 2016 and completed the study in just 5 months in early March 2017. The trial examined  parameters of comfort, recovery time and uterine healing for women undergoing  procedure.

The study participants were very enthusiastic about the treatment plan because the Cerene device, is designed to address women’s need for an effective, comfortable, office-based treatment with minimal to no downtime after the procedure.

Cerene® Cryotherapy Device screenshot

Cerene® Cryotherapy Device screenshot

“The Cerene cryoablation is a convenient, simple, and well-tolerated office procedure,” said Dr. Ted Anderson, Director of the Division of Gynecology at Vanderbilt University Medical Center and Investigator in the CLARITY study. “A patient can have this treatment the same way she has an IUD placed – in her gynecologist’s office with minimal pain management and very little discomfort. This has the potential to be a real game-changer for ablation.”

All women in the study were awake and responsive during the procedure, in contrast to heat ablation, allowing the investigators to collect data on pain scores throughout the therapy.

The Cerene Cryotherapy Device uses extreme cold to destroy tissue thereby reducing scarring and intrauterine adhesions that are often associated with heat-based treatments. Scarring and adhesions often lead to failure of procedure and reoperation. The cryothermic  delivery system was incorporated into disposable, ergonomic device that can be held by hands thereby eliminating bulky equipments.

The initial studies were presented  at 42nd American Association of Gynecologic Laparoscopists (AAGL)  Global Congress in Washington, D.C. in 2013. The subjects of initial studies were women who were scheduled for hysterectomy. The studies show that Channel Medsystems’ cryothermic therapy had an acceptable safety profile, can be performed in a clinically appropriate timeframe and was well-tolerated by the subject without the need for general anesthesia or conscious sedation.

The histopathogy specimen of the removed uteri showed selective   depth of ablation for  uterine cavity , cornua and lower uterine segment without compromising the function of uterine tissue. The results were parallel to currently-available hyperthermic therapies.

“Cerene is different from other endometrial ablation technologies I routinely use. Unlike current heat-based ablation devices, my patients actually relaxed once the two-and-a-half-minute treatment was initiated. This was a completely different treatment experience for me, my patients, and my staff,” lead investigator Dr. Jose Leal of Monterrey, Mexico’s Universidad Autónoma de Nuevo León said in a prepared statement.

This device is limited to investigational use in the US, Canada, and Mexico.

For more information visit the website www.channel medsystems.com.

        Channel Medsystems endometrial cryoablation procedure animation video

source: http://www.channel medsystems.com