Quality of Life and Sexual Function of the Novasure Endometrial Ablation in Menorrhagia

NCT ID: NCT01910584

Last Updated: 2013-07-29

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

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2015-11-30

Brief Summary

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The aim of this study is to investigate the influence on the quality of life and sexual function before, 6 month and one year after Novasure Endometrial Ablation in the treatment of Menorrhagia.

Detailed Description

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patients diagnosed menorrhagia scheduled for Novasure Endometrial Ablation because of menorrhagia between november, 2012 and november, 2014 are enrolled to this study.

patients are asked to complete preoperative questionnaires considering Health Related Quality of Life questionnaire(HRQoL) and sexual Female Sexual Functioning Index questionnaire(FSFI). Same questionnaires will also be completed six months and one year after operation.

Conditions

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Quality of Life Sexual Activity

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Novasure treated group

patients diagnosed menorrhea were treated with novasure endometrial ablation

Novasure endometrial ablation

Intervention Type PROCEDURE

Novasure endometrial ablation is the second generation endometrial ablation treatment aimed to cure the dysfunctional uterine bleeding(DUB),including menorrhagia.

Interventions

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Novasure endometrial ablation

Novasure endometrial ablation is the second generation endometrial ablation treatment aimed to cure the dysfunctional uterine bleeding(DUB),including menorrhagia.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* clinical diagnosis of menorrhagia
* family complete
* normal endometrial pathology
* had not been referred specifically for surgery
* with normal uterine cavity

Exclusion Criteria

* pregnancy or demand to preserve fertility
* acute reproductive tract inflammation or urinary tract inflammation
* pathology demonstrate endometrial cancer or precancerous change
* acute pelvic inflammation
* intrauterine device(IUD) in uterus
* depth of uterine cavity less than 4cm or more than 10cm
* pathologic myometrium( such as history of Hysteromyomectomy or classical cesarean section)
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shu-Qin Chen

OTHER

Sponsor Role lead

Responsible Party

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Shu-Qin Chen

associate professor of gynaecology and obstetrics

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Shu-Zhong Yao, PhD & MD

Role: STUDY_DIRECTOR

First Affiliated Hospital, Sun Yat-Sen University

Locations

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The First Affiliated Hospital of Sun yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shu-Qin Chen, PhD & MD

Role: CONTACT

+862087332200 ext. 8342

Facility Contacts

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Shu-Qin Chen, PhD & M.D

Role: primary

+862087332200 ext. 8342

Jin-bo Li, M.D

Role: backup

+862087332200 ext. 8342

Other Identifiers

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First-GYN-SYSU-2012

Identifier Type: -

Identifier Source: org_study_id

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