To evaluate the 12-month safety and effectiveness of transcervical ablation for the treatment of symptomatic uterine leiomyomas.
In this prospective, multicenter, single-arm interventional trial, transcervical ablation was performed on 1–10 leiomyomas per patient with leiomyoma diameters ranging from 1 to 5 cm. Treated leiomyomas included all nonpedunculated types. Coprimary endpoints assessed at 12 months were reduction in menstrual blood loss and absence of surgical reintervention. Additional assessments included symptom severity, quality of life, patient satisfaction, reductions in uterine and leiomyoma volumes, and safety.
One hundred forty-seven patients were enrolled and treated in the United States and Mexico. The study met its coprimary endpoints at 12 months (N=143; full analysis set), because 64.8% of patients (95% CI 56.3–72.6%) experienced 50% or greater reduction in menstrual bleeding and 99.3% of patients (95% CI 95.1–99.9%) were free from surgical reintervention. The mean pictorial blood loss assessment chart score decreased by 38.9%, 48.4%, and 51.1% at 3, 6, and 12 months, respectively (P<.001), and 95.1% of patients experienced a reduction in menstrual bleeding at 12 months. There were significant mean improvements in symptom severity and health-related quality of life of 32.1 points and 43.7 points, respectively, at 12 months (all P<.001). Mean maximal leiomyoma volume reduction per patient was 62.4% (P<.001). More than half of patients returned to normal activity within 1 day, 96.3% of patients reported symptom improvement at 12 months, and 97% expressed satisfaction with the treatment at 12 months. There were no device-related adverse events.
Transcervical ablation was associated with a significant reduction in leiomyoma symptoms with no device-related adverse events and a low surgical reintervention rate through 12 months, demonstrating its potential to safely and effectively treat all nonpedunculated leiomyoma types through a uterus-conserving, incisionless approach.
Funding Source: Supported by Gynesonics, Inc.
Transcervical radiofrequency ablation of leiomyomas was associated with significant improvement in heavy menstrual bleeding, overall symptoms, and health-related quality of life through 12 months.
Stamford Hospital, Stamford, Connecticut; Magee-Women's Hospital, Pittsburgh, Pennsylvania; Arizona Gynecology Consultants, Phoenix, Arizona; Mercy Hospital, St. Louis, Missouri; Virginia Mason Medical Center, Seattle, Washington; and Hospital Universitario “Dr. José Eleuterio González” de Universidad Autónoma de Nuevo León, Monterrey, NL, Mexico.
Corresponding author: Scott Chudnoff, MD, Department of Obstetrics and Gynecology, Stamford Hospital, Whittingham Pavilion, Ground Floor, 1 Hospital Plaza, Stamford, CT 06902; email: email@example.com.
The institutions involved in this study received research support from Gynesonics, Inc.
Financial Disclosure Scott Chudnoff, Richard Guido, Linda Mihalov, and José Gerardo Garza-Leal have served on the Gynesonics, Inc, advisory board. Scott Chudnoff received travel and lodging expenses for attendance at an investigator meeting and has received honoraria for speaking from Gynesonics, Inc. Kelly Roy has received royalties from CrossBay Medical, Inc. and stock options from Channel Medical, Inc, and has served as a consultant for Boston Scientific, Inc. David Levine has been a consultant for Gynesonics and a consultant for Aegea Medical. Linda Mihalov has also served on the advisory board for Abbvie. José Gerardo Garza-Leal has received a stock option grant from Gynesonics, Inc. Scott Chudnoff, Richard Guido, Kelly Roy, David Levine, and Linda Mihalov serve on the Sonography Guided Transcervical Ablation of Uterine Fibroids study steering committee.
The authors thank David Toub, MD, MBA, Medical Director of Gynesonics, Inc, and Taraneh G. Farazi, PhD, Vice-President of Clinical Affairs at Gynesonics, for contributing to the preparation and review of the manuscript. QST Consultations, LTD provided biostatistical analysis for this study.
Each author has confirmed compliance with the journal's requirements for authorship.
Peer reviews are available at http://links.lww.com/AOG/B226.
Received August 03, 2018
Received in revised form October 14, 2018
Accepted October 18, 2018