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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01910584
Enrollment
100
Registered
2013-07-29
Start date
2012-11-30
Completion date
2015-11-30
Last updated
2013-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quality of Life, Sexual Activity

Keywords

quality of life, sexual activity, Novasure endometrial ablation, menorrhagia

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.

Interventions

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

Sponsors

Shu-Qin Chen
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 50 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Quality of life and Sexual Function before, six month and one year after the Novasure Endometrial Ablationone year after Novasure Endometrial AblationQuality 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

Countries

China

Contacts

Primary ContactShu-Qin Chen, PhD & MD
chenshuqin1021@163.com+862087332200

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026