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A Randomised Control Trial To Compare the Effectiveness of Outpatient Endometrial Ablation Techniques (Novasure vs Thermachoice)in the Treatment of Menorhagia

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Trial Information

A Randomised Control Trial To Compare the Effectiveness of Outpatient Endometrial Ablation Techniques (Novasure vs Thermachoice)in the Treatment of Menorhagia

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.

Inclusion Criteria:

- Women with no desire to preserve their fertility who have heavy menstrual bleeding
without organic pathology (DUB) of more than six months duration

- Premenopausal follicular follicle stimulating hormone (FSH) level of less than 40

- Associated functional disability (negative impact on life quality).

- Lack of response to medical treatment.

- Prepared to undergo surgical treatment without general anaesthesia

Exclusion Criteria:

- Women under 25 years

- Suspected genital tract infection

- Uterine pathology including endometrial pathology on endometrial biopsy (e.g.
endometrial hyperplasia or carcinoma) and structural lesions (e.g. uterine
malformations, adhesions, polyps, submucous fibroids or extracavity fibroids > 3cm in
diameter) as identified on pelvic ultrasound and/or outpatient hysteroscopy.

- Uterine cavity length >11cm

- Adnexal pathology

- Previous open myomectomy or endometrial ablation / resection and classical caesarian

- patients considered vulnerable (e.g. current mental illness, emotionally labile,
learning difficulties, immaturity)

Type of Study:


Study Design:

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

Outcome Measure:


Outcome Description:

The objective of any treatment for HMB is to substantially reduce the amount of menstrual blood loss.Amenorrhoea rates are often chosen as the primary outcome measure in clinical trial of the effectiveness of endometrial ablation in women with HMB.

Outcome Time Frame:

6 months after the intervention.

Safety Issue:


Principal Investigator

Justin Mr Clark, MD MRCOG

Investigator Role:

Principal Investigator

Investigator Affiliation:

Birmingham Women's Hospital


United Kingdom: Research Ethics Committee

Study ID:




Start Date:

May 2006

Completion Date:

October 2008

Related Keywords:

  • Menorrhagia
  • Heavy menstrual bleeding
  • menorrhagia
  • ThermachoiceTM
  • NovaSureTM
  • Endometrail Ablation
  • Menorrhagia
  • Adenoma