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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01910584
• Other study ID #: First-GYN-SYSU-2012
• Status: Recruiting
• Phase: N/A
• First received: July 20, 2013
• Last updated: July 25, 2013
• Start date: November 2012
• Est. completion date: November 2015

Study information

• Verified date: September 2012
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Shu-Qin Chen, PhD & MD
• Phone: +862087332200
• Email: chenshuqin1021[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Menorrhagia
• Quality of Life
• Sexual Activity

Intervention

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

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Sun yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shu-Qin Chen

Country where clinical trial is conducted

China, 

Outcome

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