CompletedNot Applicable

Effectiveness of Truclear on Patient Quality of Life

United States69 participantsStarted 2014-09

Plain-language 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.

Who can participate

Age range21 Years – 80 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Quality of life score

Timeframe: Two years

Trial details

NCT IDNCT02934789

SponsorAll For Women Healthcare, Illinois

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-04

View on ClinicalTrials.gov More Heavy Menstrual Bleeding trials