Effectiveness of Truclear on Patient Quality of Life

Study Overview
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Brief Summary
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This study aims to evaluate the quality of life in patients treated for submucosal leiomyomas using the Truclear hysteroscopic morcellator compared to women managed medically. Study population includes women age 18 and older with symptomatic submucosal myomas. Patients will be asked to complete the Uterine Myoma Symptom and Health-related Quality of Life Questionnaire (UFS-QOL) at enrollment and at 1, 3, and 6 months after treatment.

Detailed Description
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Submucosal myomas are a common cause of pelvic complaints and abnormal uterine bleeding (AUB) and there are many available modalities for treatment. Hysteroscopic myomectomy is a minimally invasive approach for removal of submucosal leiomyomas. Alternatively, medical management can be attempted. This study aims to evaluate the quality of life in patients treated for submucosal leiomyomas using the Truclear hysteroscopic morcellator compared to women managed medically. Study population includes women age 18 and older with symptomatic submucosal myomas. Patients will be asked to complete the Uterine Myoma Symptom and Health-related Quality of Life Questionnaire (UFS-QOL) at enrollment and at 1, 3, and 6 months after treatment.

Official Title
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Randomized Prospective Study of the Effectiveness of the Truclear Device for Hysteroscopic Myomectomy on Patient Quality of Life

Conditions
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Heavy Menstrual Bleeding

Intervention / Treatment
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* Procedure: Hysteroscopic myomectomy with Truclear
* Drug: Medical therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with abnormal uterine bleeding and submucosal fibroid(s) undergoing hysteroscopic myomectomy or medical therapy with oral contraceptive pills Patients with Type 0, 1 or 2 submucosal myomas Exclusion Criteria: Pregnant women Patients with suspicion of uterine malignancy Patients without submucosal fibroid seen during planned hysteroscopic myomectomy Patients with active vaginal infection Patients with contraindication to hysteroscopic myomectomy Patients with cognitive impairment who are unable to provide consent and adequately complete the questionnaire.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 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
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study group: surgical arm<br>Hysteroscopic myomectomy with Truclear done on patients with abnormal uterine bleeding and submucosal fibroid(s). | Procedure: Hysteroscopic myomectomy with Truclear<br>* Hysteroscopic myomectomy with Truclear done on patients with abnormal uterine bleeding and submucosal fibroid(s).<br>* Other names: Truclear;|
| Active Comparator: Control group: medical arm<br>Medical therapy for patients with abnormal uterine bleeding/ heavy menses and submucosal fibroids | Drug: Medical therapy<br>* Medical therapy for patients with abnormal uterine bleeding/ heavy menses and submucosal fibroids.<br>* Other names: oral contraceptive pills, Mirena intrauterine device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life score | Primary outcome is the health-related quality of life (HR-QOL) as reflected from UFS-QOL scores. | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary surgical outcomes | Secondary surgical outcomes include estimated blood loss (EBL), operating time (OT), pedal resection time, fluid deficit, total fluid use, pathology report (including total myoma weight), surgical outcome and complications. | Two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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submucosal fibroids, heavy menstrual bleeding, quality of life