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

S

Shu-Qin Chen

Status

Unknown

Conditions

Quality of Life
Sexual Activity

Treatments

Procedure: Novasure endometrial ablation

Study type

Observational

Funder types

Other

Identifiers

NCT01910584
First-GYN-SYSU-2012

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

Female

Ages

25 to 50 years old

Volunteers

No Healthy Volunteers

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)

Trial design

100 participants in 1 patient group

Novasure treated group
Description:
patients diagnosed menorrhea were treated with novasure endometrial ablation
Treatment:
Procedure: Novasure endometrial ablation

Trial contacts and locations

1

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Central trial contact

Shu-Qin Chen, PhD & MD

Data sourced from clinicaltrials.gov

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