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

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

Detailed Description
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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

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

Conditions
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Menorrhagia

Intervention / Treatment
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* Procedure: novasure mirena IUS combined


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Anybody suitable for novasure ablation Exclusion Criteria: Mirena IUS is indicated as treatment
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: novasure mirena IUS combined<br>novasure mirena IUS combined therapy | Procedure: novasure mirena IUS combined<br>* novasure mirena IUS combined<br>* Other names: Combined treatment Novasure and Mirena IUS;|
| Active Comparator: novasure alone<br>Sole treatment with Novasure | Procedure: novasure mirena IUS combined<br>* novasure mirena IUS combined<br>* Other names: Combined treatment Novasure and Mirena IUS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Patient questionaire to assess periods and pain | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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novasure, Mirena IUS, menorrhagia, pelvic pain, ashermanns