Outcomes after radiofrequency ablation of uterine fibroids
Research type
Research Study
Full title
The intermediate to long-term outcomes for patients having sonography-guided transcervical ablation of uterine fibroids using the Sonata (TM) device
IRAS ID
198295
Contact name
Melody Taheri
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
10 years, 0 months, 1 days
Research summary
Uterine fibroids affect 74% of the female population before the menopause. They can cause heavy periods and pressure symptoms such as pain or needing to pass urine frequently, and can impact on fertility with significant negative effects on quality of life. The Sonata (TM) system combines ultrasound with radiofrequency ablation in a single device. This device is inserted through the opening of the cervix. The operator is able to identify the fibroids and then accurately place the ablation probe into the fibroid from the inside of the uterus using a single entry point. The treatment destroys fibroid tissue through heat. Studies of the effectiveness this treatment in Europe have been encouraging with reductions in fibroid size of 77% and improvement in symptom severity scores. This is a minimally invasive incision-free procedure associated with shorter hospital stays and decreased blood loss compared to more invasive surgery. The purpose of our study would be to monitor the outcomes for patients undergoing radiofrequency ablation as a NHS treatment offered in the Department of Gynaecology at St Mary's Hospital in Paddington. The Sonata (TM) device is CE marked and used throughout Europe. St Mary's hospital would be the first UK unit to use it and as such, it is important that we collect the intermediate and long-term outcomes for these patients. Patients consenting to involvement in the study, would be asked to participate before the procedure and at 6 months, 1 year, 2 years and 5 years after the procedure. They would be asked to score their symptoms using a symptom severity score. They would also be asked how long they required pain relief after the procedure, whether they experienced any negative effects from the procedure and whether they needed other treatments for their fibroids. Any change in their fibroid size would be documented.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
16/LO/0589
Date of REC Opinion
27 May 2016
REC opinion
Further Information Favourable Opinion