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Effectiveness of Truclear on Patient Quality of Life (HSCMyomecty)

Primary Purpose

Heavy Menstrual Bleeding

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hysteroscopic myomectomy with Truclear
Medical therapy
Sponsored by
All For Women Healthcare, Illinois
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heavy Menstrual Bleeding focused on measuring submucosal fibroids, heavy menstrual bleeding, quality of life

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)FemaleAccepts 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.

Sites / Locations

  • All For Women Healthcare

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Study group: surgical arm

Control group: medical arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

Quality of life score
Primary outcome is the health-related quality of life (HR-QOL) as reflected from UFS-QOL scores.

Secondary Outcome Measures

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.

Full Information

First Posted
October 14, 2016
Last Updated
June 26, 2018
Sponsor
All For Women Healthcare, Illinois
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT02934789
Brief Title
Effectiveness of Truclear on Patient Quality of Life
Acronym
HSCMyomecty
Official Title
Randomized Prospective Study of the Effectiveness of the Truclear Device for Hysteroscopic Myomectomy on Patient Quality of Life
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
All For Women Healthcare, Illinois
Collaborators
Medtronic

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heavy Menstrual Bleeding
Keywords
submucosal fibroids, heavy menstrual bleeding, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group: surgical arm
Arm Type
Active Comparator
Arm Description
Hysteroscopic myomectomy with Truclear done on patients with abnormal uterine bleeding and submucosal fibroid(s).
Arm Title
Control group: medical arm
Arm Type
Active Comparator
Arm Description
Medical therapy for patients with abnormal uterine bleeding/ heavy menses and submucosal fibroids
Intervention Type
Procedure
Intervention Name(s)
Hysteroscopic myomectomy with Truclear
Other Intervention Name(s)
Truclear
Intervention Description
Hysteroscopic myomectomy with Truclear done on patients with abnormal uterine bleeding and submucosal fibroid(s).
Intervention Type
Drug
Intervention Name(s)
Medical therapy
Other Intervention Name(s)
oral contraceptive pills, Mirena intrauterine device
Intervention Description
Medical therapy for patients with abnormal uterine bleeding/ heavy menses and submucosal fibroids.
Primary Outcome Measure Information:
Title
Quality of life score
Description
Primary outcome is the health-related quality of life (HR-QOL) as reflected from UFS-QOL scores.
Time Frame
Two years
Secondary Outcome Measure Information:
Title
Secondary surgical outcomes
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresa Tam, MD
Organizational Affiliation
All For Women Healthcare
Official's Role
Principal Investigator
Facility Information:
Facility Name
All For Women Healthcare
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
20733447
Citation
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):641-652. doi: 10.1097/AOG.0b013e3181ed36b3.
Results Reference
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Effectiveness of Truclear on Patient Quality of Life

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