Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry

Study Overview
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Brief Summary
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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.

Official Title
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Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry

Conditions
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Uterine Fibroids

Intervention / Treatment
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* Procedure: Radiofrequency ablation of fibroids
* Procedure: Myomectomy of fibroids


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women undergoing radiofrequency ablation.<br>Most women (75%) in the trial will be in the group who receive treatment with radiofrequency ablation (Acessa). | Procedure: Radiofrequency ablation of fibroids<br> <br> |
| Women undergoing myomectomy<br>About 25% of women in the trial will be in the group who receive treatment with myomectomy. | Procedure: Myomectomy of fibroids<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in fibroid-related symptoms after the RFA or myomectomy procedure. | 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. | Baseline to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of re-intervention for recurrent fibroid symptoms following the RFA or myomectomy procedure. |  | Baseline to 6 weeks | 
| Operative complications | 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. | Baseline to 6 weeks | 
| Pregnancy rate after the RFA or myomectomy procedure. |  | Baseline to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibroids, Radiofrequency ablation, Myomectomy