New incisionless uterine fibroid therapy sustainably safe

Approximately 70% of all women develop fibroids, benign tumors that develop in the muscular tissue of the uterine wall, during the course of their lives. In many cases, they cause no symptoms and do not require treatment. Depending on the location, size and number of fibroids, however, heavy menstrual bleeding, discomfort during sexual intercourse, menstrual cramps, pressure in the pelvic or abdominal area or reduced fertility can occur. Until now, there have been various surgical procedures available, ranging from surgical removal of the fibroid by means of uterus endoscopy (hysteroscopy) or laparoscopy to the radical removal of the entire uterus. Furthermore, secondary problems often occur following surgical removal of the fibroid: adhesions in the uterine cavity or neighboring organs, scars in the uterine wall with possible negative consequences for future pregnancies, or recurrence of fibroids with renewed symptoms. With the introduction of the Sonata® procedure a few years ago, an incisionless and precisely targeted alternative therapy is now available.

Positive experience with the Sonata® procedure
The Sonata® procedure involves a thin probe which is inserted through the cervix into the uterine cavity. The ultrasound on the tip of the probe enables the precise localization of the fibroid. Once the exact position and size of the fibroid has been determined, it is fixed with a metal tip and fan-shaped electrodes are then placed in the fibroid tissue. Radiofrequency ablation is carried out by heating the tissue in the defined zone to 105 °C. Naturally, a safe distance to the healthy tissue and surrounding organs must be maintained. With the aid of the ultrasound, the entire procedure is monitored in real time. The Sonata® procedure can be performed either under partial or general anesthesia and is ideally suited for all fibroids that lie near the uterine cavity.

New study proves absence of adhesions after the intervention
In the recently published study involving the Gynecology Department at Inselspital, Bern University Hospital, a further positive aspect of the procedure could be proven.
The patency of the uterine cavity was studied, as well the formation of adhesions/scarring, subsequent to the treatment of uterine fibroids with the Sonata® probe. In the study involving 37 patients, the condition of the uterine cavity was examined prior to and 6 weeks following the procedure. No new adhesions or similar consequential damages were documented in any of the patients after the procedure.
Professor Michael Mueller, who led the study at the Gynecology Department in Bern, emphasizes the benefit of the new technology: “With this gentle and sustainable procedure, we can largely eliminate the afflictions of the women affected with a minimally invasive procedure, without risking long-term consequential damage.”

Gynecology Department at Inselspital leads in research and application
More than 200 operations due to uterine fibroids are performed at Inselspital, Bern University Hospital every year. Today, only 15% of these are hysterectomies. Dr. Susanne Lanz affirms this with the amount of positive feedback she has received from women who participated in the study and from those outside the study: “The gentle and, in comparison to other fibroid operations, the utterly painless intervention and rapid relief of symptoms are highly appreciated, as is the fact that on average all normal activities, including work, are possible again after only four days.

Experts:
– Dr. med. Susanne Lanz, Prof. Dr. med. Michael Mueller
Contact:
– Insel Gruppe AG, Communication: +41 31 632 79 25, kommunikation@insel.ch

Literature:
– Marlies Bongersa*, Stephen D. Quinnc, Michael D. Mueller et al. 2019: Evaluation of uterine patency following transcervical uterine fibroid ablation with the Sonata system (the OPEN clinical trial); Eur J Obstet Gynecol Reprod Biol. 2019 Nov;242:122-125
– David B. Toub, 2017: A New Paradigm for Uterine Fibroid Treatment: Transcervical, Intrauterine Sonography-Guided Radiofrequency Ablation of Uterine Fibroids with the Sonata SystemCurr Obstet Gynecol Rep (2017) 6:67–73. DOI 10.1007/s13669-017-0194-2

Insel Gruppe

The Insel Gruppe is Switzerland’s leading group of hospitals for university and integrated medicine. It offers comprehensive health care based on ground-breaking quality, research, innovation and education. The six Insel Gruppe hospitals (Inselspital, Aarberg, Belp, Münsingen, Riggisberg and Tiefenau) carried out around 822,000 out-patient consultations and treated over 65,000 in-patients in the financial year 2018. The Insel Gruppe employs almost 11,000 members of staff from 100 nations. It provides training for a large number of professions and is the most important institution for the further training of young physicians.

contact for scientific information:
Dr. med. Susanne Lanz, Prof. Dr. med. Michael Mueller
Insel Gruppe AG, Communication: +41 31 632 79 25, kommunikation@insel.ch

original publication:
Marlies Bongersa*, Stephen D. Quinnc, Michael D. Mueller et al. 2019: Evaluation of uterine patency following transcervical uterine fibroid ablation with the Sonata system (the OPEN clinical trial); Eur J Obstet Gynecol Reprod Biol. 2019 Nov;242:122-125

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