Effectiveness of Truclear on Patient Quality of Life

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2018-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Heavy Menstrual Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study group: surgical arm

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

Group Type ACTIVE_COMPARATOR

Hysteroscopic myomectomy with Truclear

Intervention Type PROCEDURE

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

Control group: medical arm

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

Group Type ACTIVE_COMPARATOR

Medical therapy

Intervention Type DRUG

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

Interventions

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Hysteroscopic myomectomy with Truclear

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

Intervention Type PROCEDURE

Medical therapy

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

Intervention Type DRUG

Other Intervention Names

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Truclear oral contraceptive pills, Mirena intrauterine device

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes