An interventional study of novasure mirena IUS combined in Menorrhagia, sponsored by Walsall Healthcare NHS Trust. Status unknown at 1 site in United Kingdom. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-10-18.
Sponsored by Walsall Healthcare NHS Trust · Not applicable, Interventional, and Prevention
Hypothesis. Combined treatment with novasure and mirena IUS confers benefit over Novasure alone in the treatment of menorrhagia
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
188 studies on the registry are indexed under Menorrhagia; 34 are open to participants now.
This study's planned enrollment of 100 is close to the median of 98 across 139 interventional studies indexed under Menorrhagia.
Browse Menorrhagia studies →This is the only study on the registry with Walsall Healthcare NHS Trust as lead sponsor.
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Exclusion Criteria:
novasure mirena IUS combined therapy
Procedure: novasure mirena IUS combined
Sole treatment with Novasure
Procedure: novasure mirena IUS combined
novasure mirena IUS combined
Also known as: Combined treatment Novasure and Mirena IUS
Quality of life
Patient questionaire to assess periods and pain
Time frame: 6 months
This study is status unknown, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
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