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Clinical Trials/NCT01910584
NCT01910584
Unknown
Not Applicable

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

Shu-Qin Chen1 site in 1 country100 target enrollmentNovember 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Quality of Life
Sponsor
Shu-Qin Chen
Enrollment
100
Locations
1
Primary Endpoint
Quality of life and Sexual Function before, six month and one year after the Novasure Endometrial Ablation
Last Updated
12 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
November 2012
End Date
November 2015
Last Updated
12 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Shu-Qin Chen
Responsible Party
Sponsor Investigator
Principal Investigator

Shu-Qin Chen

associate professor of gynaecology and obstetrics

First Affiliated Hospital, Sun Yat-Sen University

Eligibility Criteria

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)

Outcomes

Primary Outcomes

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

Study Sites (1)

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