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

July 25, 2013 updated by: Shu-Qin Chen

Prospective Study of the Influence on Quality of Life and Sexual Function of the Novasure Endometrial Ablation in the Treatment of Menorrhagia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • The First Affiliated Hospital of Sun Yat-sen University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jin-bo Li, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

100 patients diagnosed menorrhagia scheduled for Novasure endometrial ablation in The First Affiliated Hospital between November 2012 and November 2015

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Novasure treated group
patients diagnosed menorrhea were treated with novasure endometrial ablation
Procedure: Novasure endometrial ablation
Novasure endometrial ablation is the second generation endometrial ablation treatment aimed to cure the dysfunctional uterine bleeding(DUB),including menorrhagia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life and Sexual Function before, six month and one year after the Novasure Endometrial Ablation
Time Frame: one year after Novasure Endometrial Ablation
Quality of life assessed with Health Related Quality of Life questionnaire(HRQoL) before, six month and one year after the Novasure Endometrial Ablation; Sexual Function measured with Female Sexual Functioning Index questionnaire(FSFI) before, six month and one year after the Novasure Endometrial Ablation
one year after Novasure Endometrial Ablation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shu-Qin Chen

Investigators

  • Study Director: Shu-Zhong Yao, PhD & MD, First Affiliated Hospital, Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Anticipated)

November 1, 2015

Study Completion (Anticipated)

November 1, 2015

Study Registration Dates

First Submitted

July 20, 2013

First Submitted That Met QC Criteria

July 25, 2013

First Posted (Estimate)

July 29, 2013

Study Record Updates

Last Update Posted (Estimate)

July 29, 2013

Last Update Submitted That Met QC Criteria

July 25, 2013

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • First-GYN-SYSU-2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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