LONDON — A newer version of the Thermachoice endometrial ablation system shows better efficacy and patient satisfaction than one of its predecessors, according to data presented at the annual congress of the International Society for Gynecologic Endoscopy.
New clinical efficacy data on the Thermachoice III balloon ablation system, which was approved in 2003 by the Food and Drug Administration, suggest it is an improvement on the first Thermachoice system, said Fiona Marsh, M.D., who presented two studies that were partially funded by Gynecare, which makes the product.
Thermachoice was launched in the United States in 1998, and Thermachoice II, a revised version of the system, had its U.S. launch in 2000. Thermachoice II was not marketed in England, where Dr. Marsh practices. The two studies she presented at the meeting focused on Thermachoice III.
“My results on patient satisfaction and symptom reduction with Thermachoice III do look better than results that have been published for Thermachoice I,” she told this newspaper.
“These are also the first data on the feasibility of performing Thermachoice III in the outpatient setting—information which is imperative for clinicians to be able to counsel women appropriately,” she said.
Gynecare data suggest that Thermachoice III achieves greater thermal effect and depth of necrosis than the original version, but to date there have been no studies assessing symptom reduction or pain with the procedure, said Dr. Marsh, a clinical research fellow at St. James's Hospital, Leeds, England.
Her first study found improved patient satisfaction with the treatment in both the office and hospital outpatient settings—with improvements in dysmenorrhea in 87%, improvements in irregular menstruation in 66%, and improvements in quality of life in 84% of the 44 women in the study. Overall, 87% of the women said they were satisfied with the effects of the treatment—an improvement over previous studies showing a 67% satisfaction rate with the original Thermachoice, Dr. Marsh said.
The second study assessed intraoperative pain with Thermachoice III in patients treated in the office setting without local analgesia or intravenous sedation.
“Since Thermachoice III provides deeper and wider endometrial coverage, compared with the earlier version, we wanted to see if this had an effect on intraoperative pain scores” in patients treated in the office, Dr. Marsh said.
A total of 38 women with menorrhagia were included in the study. For pain prevention, they were given high-dose ibuprofen (800 mg) orally the night before the procedure and again 1 hour before undergoing endometrial ablation.
Intraoperatively, the women were offered rescue analgesia in the form of inhaled nitrous oxide, and after surgery they had the option of having tramadol 100 mg.
A total of 32 women (87%) were able to complete the 8-minute treatment, with 5 requesting it be stopped because of pain. Using a visual analog scale, with 10 describing the worst pain possible, 15% women reported scores of at least 7, including 3 reporting a score of 10.
Twenty-nine percent of the patients requested rescue analgesia, compared with the 12% rate in her unit when the original version of the system was used.
“Performing Thermachoice III in the [office] setting is tolerable for the vast majority of patients, and pretreatment with ibuprofen meant most patients did not need intraoperative rescue analgesia,” Dr. Marsh said.
“This provides women with an [in-office] option, if they would prefer to avoid general anesthesia,” she said.
Most of the patients went home about a half hour after they finished the treatment session.
“None of them came back with complications, and 5% called about cramping. Most of them used ibuprofen for 2–3 days after the procedure,” Dr. Marsh said.