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

Menorrhagia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01965587
• Other study ID #: Novasure2013
• Status: Not yet recruiting
• Phase: N/A
• First received: October 15, 2013
• Last updated: October 17, 2013
• Start date: December 2013

Study information

• Verified date: October 2013
• Source: Walsall Healthcare NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: R&D NHS ethics committee at Heartlands Hospital
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Anybody suitable for novasure ablation

Exclusion Criteria:

• Mirena IUS is indicated as treatment

Study Design

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

Related Conditions & MeSH terms

• Menorrhagia

Intervention

Procedure:
• novasure mirena IUS combined
novasure mirena IUS combined

Locations

Country	Name	City	State
United Kingdom	Walsall Manor Hospital	Walsall	West Midlands

Sponsors (1)

Lead Sponsor	Collaborator
Walsall Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life	Patient questionaire to assess periods and pain	6 months	Yes