Effectiveness of Truclear on Patient Quality of Life

• Status: Completed
• Trial end date: 2018-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: All For Women Healthcare, Illinois
• Collaborator: Medtronic
• Treatments: Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined

Criteria

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.