In-office Hysteroscopic Laser Ablation for Symptomatic Submucous Uterine Fibroids

Study Overview
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Brief Summary
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To evaluate feasibility and efficacy of in-office hysteroscopic ablation of submucous uterine fibroid using diode laser

Detailed Description
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A pilot study was conducted between January 2018 and January 2019 in a tertiary care university hospital. Patients with at least one symptomatic, class 0-2 of FIGO classification, uterine fibroid of ≤ 7cm in size were eligible for inclusion. Evaluation of the changes in fibroid size and vascularity was performed using 3D Doppler ultrasonography. Vaporization of the fibroid core was conducted using a 1470nm wavelength diode laser inserted through the hysteroscope's working channel. Primary outcome was the evaluation of the fibroid volume before and at 2 months after the procedure.

Official Title
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In-office Hysteroscopic Laser Ablation for Symptomatic Submucous Uterine Fibroids: Impact on Size and Vascularization.

Conditions
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Laser Hysteroscopic Ablation of Submucous Myoma

Intervention / Treatment
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* Device: hysteroscopic ablation of submucous uterine fibroid using diode laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: symptomatic patients without desire of future fertility (symptoms included heavy menstrual bleeding, abdominal discomfort, bulk symptoms such as urinary frequency, pelvic pressure and constipation), grade 0-2 (FIGO classification) ≤ 7cm fibroids with evident vascularity seen by 3D-DS compared to its adjacent myometrial tissue Exclusion Criteria: intramural fibroids (FIGO class 3 or more), >2 submucosal fibroids, pelvic inflammatory disease, known gynecologic malignancy, severe cervical stenosis, pregnancy desire of future fertility, previous cervical surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: patients with symptomatic submucosal fibroides were elected for hysteroscopy laser ablation of the fibroid
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Symptomatic submucosal myoma<br>patients with symptomatic submucosal fibroids (heavy menstrual bleeding) were elected for hysteroscopy with laser ablation of the myoma. | Device: hysteroscopic ablation of submucous uterine fibroid using diode laser<br>* patients with symptomatic submucosal fibroids (heavy menstrual bleeding) were elected for hysteroscopy and laser ablation of the myoma<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding | improvement of the heavy menstrual bleeding | before the procedure and at 3 months follow up visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fibroid volume reduction | measure by US the reduction of the myoma size | before the procedure and at 3 months follow up visit | 
| changes on the myoma vascularity | measure by 3D US Doppler Color | before the procedure and at 3 months follow up visit |