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

Walsall Healthcare NHS Trust

Status: Unknown

Conditions: Menorrhagia

Treatments: Procedure: novasure mirena IUS combined

Study type: Interventional

Funder types: Other

Identifiers

NCT01965587

Novasure2013

Details and patient eligibility

About

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

Full 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

Enrollment: 100 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Anybody suitable for novasure ablation

Exclusion criteria

• Mirena IUS is indicated as treatment

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

novasure mirena IUS combined

Active Comparator group

Description:

novasure mirena IUS combined therapy

Treatment:

Procedure: novasure mirena IUS combined

novasure alone

Active Comparator group

Description:

Sole treatment with Novasure

Treatment:

Procedure: novasure mirena IUS combined