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

Primary Purpose

Menorrhagia

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
novasure mirena IUS combined
Sponsored by
Walsall Healthcare NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Menorrhagia focused on measuring novasure, Mirena IUS, menorrhagia, pelvic pain, ashermanns

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Anybody suitable for novasure ablation

Exclusion Criteria:

  • Mirena IUS is indicated as treatment

Sites / Locations

  • Walsall Manor Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

novasure mirena IUS combined

novasure alone

Arm Description

novasure mirena IUS combined therapy

Sole treatment with Novasure

Outcomes

Primary Outcome Measures

Quality of life
Patient questionaire to assess periods and pain

Secondary Outcome Measures

Full Information

First Posted
October 15, 2013
Last Updated
October 17, 2013
Sponsor
Walsall Healthcare NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01965587
Brief Title
RCT Novasure Versus Novasure + Mirena IUS in the Treatment of Menorrhagia
Official Title
RCT Novasure Versus Novasure + Mirena IUS in the Treatment of Menorrhagia. A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Walsall Healthcare NHS Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menorrhagia
Keywords
novasure, Mirena IUS, menorrhagia, pelvic pain, ashermanns

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
novasure mirena IUS combined
Arm Type
Active Comparator
Arm Description
novasure mirena IUS combined therapy
Arm Title
novasure alone
Arm Type
Active Comparator
Arm Description
Sole treatment with Novasure
Intervention Type
Procedure
Intervention Name(s)
novasure mirena IUS combined
Other Intervention Name(s)
Combined treatment Novasure and Mirena IUS
Intervention Description
novasure mirena IUS combined
Primary Outcome Measure Information:
Title
Quality of life
Description
Patient questionaire to assess periods and pain
Time Frame
6 months

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Anybody suitable for novasure ablation Exclusion Criteria: Mirena IUS is indicated as treatment
Facility Information:
Facility Name
Walsall Manor Hospital
City
Walsall
State/Province
West Midlands
ZIP/Postal Code
ws29ps
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jonathan pepper, frcog
Phone
00441922721172
Ext
7735
Email
jonathan.pepper@walsallhealthcare.nhs.uk
First Name & Middle Initial & Last Name & Degree
Subashini Sivalingam, MRCOG

12. IPD Sharing Statement

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

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