Effectiveness of Truclear on Patient Quality of Life

Heavy Menstrual Bleeding Clinical Trial

— HSCMyomecty  

Official title:

Randomized Prospective Study of the Effectiveness of the Truclear Device for Hysteroscopic Myomectomy on Patient Quality of Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02934789
• Other study ID #: 2015-17
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: May 2018

Study information

• Verified date: June 2018
• Source: All For Women Healthcare, Illinois
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: May 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heavy Menstrual Bleeding
• Hemorrhage
• Menorrhagia

Intervention

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

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

Locations

Country	Name	City	State
United States	All For Women Healthcare	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
All For Women Healthcare, Illinois	Medtronic

Country where clinical trial is conducted

United States, 

References & Publications (1)

Spies JB, Bradley LD, Guido R, Maxwell GL, Levine BA, Coyne K. Outcomes from leiomyoma therapies: comparison with normal controls. Obstet Gynecol. 2010 Sep;116(3):641-52. doi: 10.1097/AOG.0b013e3181ed36b3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life score	Primary outcome is the health-related quality of life (HR-QOL) as reflected from UFS-QOL scores.	Two years
Secondary	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.	Two years