Uterine Fibroids
Conditions
Keywords
Fibroids, Radiofrequency ablation, Myomectomy
Brief summary
The ULTRA Registry is a nationwide observational arm of the ULTRA trial. Data from the ULTRA Registry will be used to evaluate the long-term safety and efficacy of laparoscopic RF ablation (Acessa). The ULTRA Registry will recruit women age 21 or older who plan to undergo or have undergone laparoscopic RF ablation (Acessa) or myomectomy within the United States. Participants will be recruited through study materials distributed at clinical offices across the country where gynecologists are performing laparoscopic RF ablation (Acessa). Study participants will consent to participate in a 3 year prospective study conducted by UCSF but the fibroid procedure will be performed by the study participants' own gynecologist. We will evaluate changes in fibroid-related symptoms from pre-treatment values to 6, 12, 18, 24, 30, and 36 months after RFA (Acessa). We will determine long-term efficacy of RFA (Acessa) by evaluating the rate of re-treatment for symptomatic fibroids after the RFA (Acessa) procedure versus myomectomy. Participants will be asked for permission to review their medical records to assess surgical and pregnancy outcomes. UC San Francisco will have oversight of all scientific and administrative aspects of the study. All study data will be stored securely in a HIPAA compliant, secure database monitored by the UC San Francisco Coordinating Center.
Interventions
PROCEDURERadiofrequency ablation of fibroids
PROCEDUREMyomectomy of fibroids
Sponsors
University of California, San Francisco
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Planning to undergo or have undergone\* RF ablation (Acessa) or myomectomy (laparoscopic or abdominal) for treatment of uterine fibroids. * Able to give informed consent * Speak English or Spanish * Women enrolled at contracted clinical sites must enroll prior to their RF ablation treatment
Exclusion criteria
* \<21 years of age * Plan to undergo hysteroscopic myomectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in fibroid-related symptoms after the RFA or myomectomy procedure. | Baseline to 3 years | We will use standard questionnaires for women with fibroids to assess changes in fibroid symptoms including menstrual pattern and flow and overall quality of life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of re-intervention for recurrent fibroid symptoms following the RFA or myomectomy procedure. | Baseline to 6 weeks | — |
| Operative complications | Baseline to 6 weeks | Operative complications are rare but may include excessive blood loss, uterine or pelvic infection, injury to organs adjacent to uterus such as bowel or bladder. |
| Pregnancy rate after the RFA or myomectomy procedure. | Baseline to 3 years | — |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORVanessa Jacoby, MD
University of California, San Francisco
Outcome results
None listed