Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry

Active, not recruiting

Interventions: Procedure: Radiofrequency ablation of fibroids
Procedure: Myomectomy of fibroids

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Women undergoing radiofrequency ablation.	Radiofrequency ablation of fibroids	Most women (75%) in the trial will be in the group who receive treatment with radiofrequency ablation (Acessa).
Women undergoing myomectomy	Myomectomy of fibroids	About 25% of women in the trial will be in the group who receive treatment with myomectomy.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Locations (12): UC Irvine Medical Center
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Irvine, California, United States
University of California, San Francisco
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San Francisco, California, United States
Fibroid and Pelvic Wellness Center of Georgia
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Alpharetta, Georgia, United States
Women's Healthcare Associates of IL, SC
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Homewood, Illinois, United States
Tassone Advanced Gynecology
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Austin, Texas, United States
MacArthur Medical Center
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Irving, Texas, United States
University of California, San Diego
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San Diego, California, United States
Dedicated to Women
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Dover, Delaware, United States
Gynecology Institute of Chicago
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Chicago, Illinois, United States
Duke University
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Durham, North Carolina, United States
UT Southwestern
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Dallas, Texas, United States
Acacia OBGYN
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San Antonio, Texas, United States