An interventional study of Hysteroscopic myomectomy with Truclear and Medical therapy in Heavy Menstrual Bleeding, sponsored by All For Women Healthcare, Illinois. Completed at 1 site in United States. Open to female participants aged 21 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-27.
Sponsored by All For Women Healthcare, Illinois · Not applicable, Interventional, and Treatment
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.
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.
182 studies on the registry are indexed under Menorrhagia; 33 are open to participants now.
This study's enrollment of 69 is below the median of 100 across 133 interventional studies indexed under Menorrhagia.
Browse Menorrhagia studies →This is the only study on the registry with All For Women Healthcare, Illinois as lead sponsor.
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Exclusion Criteria:
Hysteroscopic myomectomy with Truclear done on patients with abnormal uterine bleeding and submucosal fibroid(s).
Procedure: Hysteroscopic myomectomy with Truclear
Medical therapy for patients with abnormal uterine bleeding/ heavy menses and submucosal fibroids
Drug: Medical therapy
Hysteroscopic myomectomy with Truclear done on patients with abnormal uterine bleeding and submucosal fibroid(s).
Also known as: Truclear
Medical therapy for patients with abnormal uterine bleeding/ heavy menses and submucosal fibroids.
Also known as: oral contraceptive pills, Mirena intrauterine device
Quality of life score
Primary outcome is the health-related quality of life (HR-QOL) as reflected from UFS-QOL scores.
Time frame: Two years
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.
Time frame: Two years
Plan to share: Yes
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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