Effectiveness of Truclear on Patient Quality of Life

All For Women Healthcare, Illinois69 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Heavy Menstrual Bleeding

Interventions

Hysteroscopic myomectomy with TruclearPROCEDURE

Hysteroscopic myomectomy with Truclear done on patients with abnormal uterine bleeding and submucosal fibroid(s).

Medical therapyDRUG

Medical therapy for patients with abnormal uterine bleeding/ heavy menses and submucosal fibroids.

Eligibility

Sex: FEMALEMin age: 21 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

All For Women Healthcare

Chicago, Illinois, United States

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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