Clinical Trial: RCT Novasure Versus Novasure + Mirena IUS in the Treatment of Menorrhagia

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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

Detailed Summary:

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 bleedi
  Sponsor: Walsall Healthcare NHS Trust
  

  Current Primary Outcome: Quality of life [ Time Frame: 6 months ]

  Patient questionaire to assess periods and pain
  
  
  

  Original Primary Outcome: Same as current
  
  

  Current Secondary Outcome:
  
  

  Original Secondary Outcome:
  
  Information By: Walsall Healthcare NHS Trust
  

  Dates:
  Date Received: October 15, 2013
  Date Started: December 2013
  Date Completion:
  Last Updated: October 17, 2013
  Last Verified: October 2013