Quality of Life Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | November 2015 |
Est. primary completion date | November 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 25 Years to 50 Years |
Eligibility |
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) |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Sun yat-sen University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Shu-Qin Chen |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quality of life and Sexual Function before, six month and one year after the 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 | No |
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