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RCT Novasure Versus Novasure + Mirena IUS in the Treatment of Menorrhagia

Information source: Walsall Healthcare NHS Trust
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Menorrhagia

Intervention: novasure mirena IUS combined (Procedure)

Phase: N/A

Status: Not yet recruiting

Sponsored by: Walsall Healthcare NHS Trust

Summary

Hypothesis. Combined treatment with novasure and mirena IUS confers benefit over Novasure alone in the treatment of menorrhagia

Clinical Details

Official title: RCT Novasure Versus Novasure + Mirena IUS in the Treatment of Menorrhagia. A Pilot Study

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Primary outcome: Quality of life

Detailed description: Endometrial ablation is a commonly used treatment option for women with heavy periods. It is recommended as an initial treatment. It aims at destroying the lining of the womb to reduce heavy menstrual loss. A hormone releasing device in the womb (MIRENA«)is another commonly used treatment for women with heavy menstrual bleeding and has added benefit of reducing cyclical pain. There is an increase in the number of women presenting to gynaecology clinic with persistence of pain or cyclical pain with absent or light bleeding after second generation endometrial ablation (Novasure). This may be due to the pockets of active lining of the womb that remains after ablation or possible adhesions created by the treatment. Most women require surgical removal of the womb (hysterectomy) because of pain or a further surgical procedure to divide these adhesions in an attempt to relieve pain and drain any collections in the womb. We aim to determine if the combined use of MIRENA┬« and NOVASURE┬« (which is the second generation endometrial ablation technique used in our unit) will help in reducing the number of women presenting with cyclical pain and requiring further intervention or surgery. The aim of the current study is to compare between women receiving only NOVASURE treatment and women receiving combined NOVASURE and MIRENA treatment for heavy menstrual bleeding. The primary and secondary outcomes will be assessed at 6 and 12 months by a patient questionnaire. The primary outcome is improvement in quality of life The secondary outcomes include

- Lowering of surgical intervention

- Reduction in pain

- Reduction in amount of bleeding This will be a pilot study to determine if the theory

is correct and then a larger powered study can be undertaken

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Anybody suitable for novasure ablation

Exclusion Criteria:

- Mirena IUS is indicated as treatment

Locations and Contacts

Walsall Manor Hospital, Walsall, West Midlands ws29ps, United Kingdom; Not yet recruiting
jonathan pepper, frcog, Phone: 00441922721172, Ext: 7735, Email: jonathan.pepper@walsallhealthcare.nhs.uk
Subashini Sivalingam, MRCOG, Principal Investigator
Additional Information

Starting date: December 2013
Last updated: October 17, 2013

Page last updated: August 23, 2015

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