Effectiveness of Truclear on Patient Quality of Life (HSCMyomecty)

All For Women Healthcare, Illinois

Status: Completed

Conditions: Heavy Menstrual Bleeding

Treatments: Procedure: Hysteroscopic myomectomy with Truclear; Drug: Medical therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02934789

2015-17

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 69 patients

Sex: Female

Ages: 21 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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69 participants in 2 patient groups

Study group: surgical arm

Active Comparator group

Description:

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

Treatment:

Procedure: Hysteroscopic myomectomy with Truclear

Control group: medical arm

Active Comparator group

Description:

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

Treatment:

Drug: Medical therapy