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

• Conditions: Quality of Life; Sexual Activity
• Interventions: Procedure: Novasure endometrial ablation

• Registration Number: NCT01910584
• Lead Sponsor: Shu-Qin Chen

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.

Study Timeline

• Status Verified: 2012-09
• Study Start: 2012-11
• Study First Submitted: 2013-07-20
• Study First Submitted QC: 2013-07-25
• Last Update Submitted: 2013-07-25
• Study First Posted: 2013-07-29
• Last Update Posted: 2013-07-29
• Primary Completion: 2015-11
• Study Completion: 2015-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Novasure treated group	Novasure endometrial ablation	patients diagnosed menorrhea were treated with novasure endometrial ablation

Primary Outcome Measures

Name	Time	Method
Quality of life and Sexual Function before, six month and one year after the Novasure Endometrial Ablation	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

Trial Locations

Locations (1)

The First Affiliated Hospital of Sun yat-sen University; 🇨🇳 Guangzhou, Guangdong, China