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

Menorrhagia Clinical Trial

— COAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01124357
• Other study ID #: CLA004.
• Status: Completed
• Phase: N/A
• First received: March 18, 2010
• Last updated: May 14, 2010
• Start date: May 2006
• Est. completion date: October 2008

Study information

• Verified date: May 2006
• Source: Birmingham Women's NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: October 2008
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years and older

Eligibility

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 IU/L.

• 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 section

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

Study Design

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

Related Conditions & MeSH terms

• Menorrhagia

Intervention

Device:
• NovaSure
Bipolar radio-frequency energy ablation of the endometrium by thermal therapy under impedance control. The bipolar current generated by the device produces a tapered depth of ablation with shallower ablation in the cornual regions / lower uterine segment and a deeper ablation in the mid-body of the uterus..
• thermachoice
ThermachoiceTM III thermal balloon ablation

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Birmingham Women's NHS Foundation Trust	Hologic, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amenorrhoea	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.	6 months after the intervention.	No
Secondary	Visual analogue scale for assessment of pain	The main limitation of outpatient interventions is the amount of pain generated. Endometrial ablation has been shown to be feasible and generally well tolerated in conscious patients in small observational series10-11, but direct randomised comparisons between techniques regarding the amount of pain experienced during surgery are lacking	24 hours	No