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A Study to Compare the Effectiveness of Two Different Outpatient Endometrial Ablation Techniques Used for Heavy Periods

2014-08-27 03:13:40 | BioPortfolio

Summary

STUDY HYPOTHESIS: Does outpatient NovaSureTM endometrial ablation alleviate excessive menstrual bleeding and improve life quality more effectively than outpatient ThermachoiceTM endometrial ablation?

Description

Heavy menstrual bleeding (HMB) or 'menorrhagia' is a common condition with a major impact on health-related quality of life and health resource utilization in both primary and secondary care. In over 50% of cases no organic pathology is present and the term dysfunctional uterine bleeding (DUB) is used. First line treatment of DUB is medical and where this fails, surgery is indicated using either minimally invasive approaches (endometrial ablation) or major surgery (hysterectomy). Endometrial ablation has been extensively evaluated against the gold standard of hysterectomy and shown to be effective and associated with fewer complications. The technique involves destroying the entire, or a substantial proportion, of the endometrium thereby preventing cyclical endometrial regeneration and suppressing or reducing menstrual blood loss. Recent advances in endoscopic technology have resulted in the development of miniature, automated ablative systems (so called 'second generation devices'), which are easy to use, safe and obviate the need for routine unpleasant and expensive endometrial preparatory drugs10. Moreover, these devices have the potential to be routinely used in the outpatient or 'office' setting without the need for general anaesthesia. This approach is increasingly being advocated as it expands patient choice and potentially increasing safety and cost-effectiveness of treatment.

The three most commonly employed and evaluated ablative devices are ThermachoiceTM III thermal balloon ablation (Gynecare Inc, Somerville, NJ, USA), Microwave endometrial ablation (Microsulis plc, Waterlooville, Hampshire, UK) and NovaSureTM impedance-controlled endometrial ablation (Cytyc, Marlborough, MA USA). All appear to have comparable efficacy when employed as an inpatient under general anaesthesia in terms of patient satisfaction and life quality although data on direct head to head comparisons of these procedures when performed in an outpatient environment are scarce. All techniques have been employed without the need for general anaesthesia11,16-19, but only ThermachoiceTM has been reported in an outpatient setting11, without the need for formal theatre facilities or conscious sedation. The Microwave technique necessitates significant dilatation of the cervix that limits its potential for use in an outpatient setting in contrast to ThermachoiceTM and NovaSureTM10.

The newer NovasureTM system is more effective than ThermachoiceTM because inpatient studies report a higher rate of amenorrhoea (cessation of menstrual periods - 43% versus 8%). Moreover, NovaSureTM may be a better technique for use in conscious patients in an outpatient setting as it is a shorter procedure (1.5 versus 8 minutes) and associated with less post-operative pain16,19 but it does require a greater degree of potentially painful cervical dilatation10. There is thus a need for a randomised trial to compare the effectiveness and acceptability of ThermachoiceTM and NovaSureTM endometrial ablation in an outpatient setting for the treatment of menorrhagia.

Study Design

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

Conditions

Menorrhagia

Intervention

NovaSure, thermachoice

Status

Completed

Source

Birmingham Women's NHS Foundation Trust

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:40-0400

Clinical Trials [31 Associated Clinical Trials listed on BioPortfolio]

Hysterectomy and Levonorgestrel Releasing Intrauterine System (LNG-IUS) in the Treatment of Menorrhagia

A randomised study including 236 women referred for essential menorrhagia to five university hospitals in Finland was conducted to compare the cost-effectiveness and the quality of life is...

Efficacy and Safety Study of XP12B in Women With Menorrhagia

The purpose of this study is to determine whether XP12B is effective and safe in the treatment of women with heavy menstrual bleeding associated with menorrhagia.

Ultrasound Appearance of the Endometrium Post Radio-Frequency Ablation

- The study primarily aims to evaluate the post ablative endometrium and uterus using transvaginal ultrasound to provide descriptive information as to what may be expected in th...

Safety Study of XP12B in Women With Menorrhagia

The purpose of this study is to evaluate the safety of XP12B in women with heavy menstrual bleeding associated with menorrhagia.

Mirena in Idiopathic Menorrhagia

This is an open-label, uncontrolled, multi-centre observational study that analyses a follow-up of 1600 women with dysfunctional uterine bleeding (idiopathic menorrhagia) over a period of ...

PubMed Articles [13 Associated PubMed Articles listed on BioPortfolio]

No. 163-Gynaecological and Obstetric Management of Women With Inherited Bleeding Disorders.

The prevalence of bleeding disorders, notably von Willebrand disease (vWD), among adult women with objectively documented menorrhagia is consistently reported to be 10% to 20% and is even higher in ad...

Endometrial cancer after endometrial ablation or resection for menorrhagia.

To assess the incidence of endometrial cancer after endometrial ablation or resection (EA/R) for menorrhagia.

Menorrhagia Outcomes of Minimally Invasive Treatments (MOMITS): A 2 to 5-year follow-up.

We conducted a retrospective postal questionnaire-based study to assess the effectiveness and patient experience of minimally invasive treatments for menorrhagia by performing a two- to five-year foll...

Incidence and burden of gynecologic disorders, active component service women, U.S. Armed Forces, 2012-2016.

This report describes the incidence, burden, and co-occurrence of four common gynecologic disorders among active component service women during 2012-2016. Overall incidence rates were highest for meno...

Letter: Epidural Steroid Injection-Induced Menorrhagia: An Under-recognized Complication Associated With a Common Spinal Intervention.

Medical and Biotech [MESH] Definitions

Excessive uterine bleeding during MENSTRUATION.

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