Condition category
Urological and Genital Diseases
Date applied
07/01/2013
Date assigned
11/02/2013
Last edited
11/02/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Excessive menstrual bleeding, or menorrhagia, is a significant health problem in women in reproductive age. It can cause anemia and reduce their quality of life. We want to compare the effectiveness and acceptability of two second-generation endometrial ablation [is a medical procedure that is used to remove (ablate) or destroy the endometrial lining of a uterus] techniques, bipolar radiofrequency endometrial ablation and balloon ablation in the treatment of menorrhagia.

Who can participate?
This study aims to recruit about 104 women with menorrhagia who want to undergo an endometrial ablation.

What does the study involve?
Over a period of about three years participants will be undergo an endometrial ablation randomly allocated to bipolar endometrial ablation or balloon ablation in the outpatient clinic.
Visual analogue scales will be used to measure pain when dilating the cervix, during the endometrial ablation, and at 1,4,12 and 24 hours after the procedure. Follow-up visits at the outpatient clinic or by telephone will be at 6 weeks, 6 months and 12 months after the initial treatment. At each follow up visit, duration of menstruation, presence of dysmenorrhea and clots will be registered. Patients will also complete a pictorial chart, and will express their satisfaction about the treatment result.
At the end of the study, we will compare the amount of women with amenorrhea. Other outcome measures will be painscores, reduction in bleeding, patient satisfaction and re-interventions.

What are the possible benefits and risks of participating?
These are women who already want an endometrial ablation to be performed for their menorrhagia. The identifiable risks associated with the use of the Novasure and/or Thermablate ablation as well as participation in this study is as follows: hemorrhage, perforated uterine wall, lacerated cervical canal, cervical stenosis, urinary tract/vaginal infection, hematometra, thermal damage, endometritis, abdominal surgery to repair a possible perforation and post-coital bleeding. Other clinical events include pelvic cramping, vaginal discharge, nausea/vomiting, post ablation tubal sterilization syndrome and pregnancy following ablation, which may be dangerous to the mother and fetus. All risks are possible and the chance of their occurrence is low. There is also the risk that the surgery may not be effective or the patient may not be able to be treated because of obstructions within the cavity, an unusual cavity shape or an insufficient cornu-to-cornu width. All adverse events or complications, device related or not, will be recorded and reported.

Where is the study run from?
The study has been set up by the department of Obstetrics & Gynecology in the Maxima Medical Centre in Veldhoven, The Netherlands. Other participating hospitals are the TweeSteden Kliniek in Tilburg and the ZuidOostKliniek in Amsterdam, the Netherlands.

When is the study starting and how long is it expected to run for?
Recruitment started in March 2009 and we expect it to run for about three years. Participants were enrolled on the study for a period of one year.

Who is funding the study?
Maxima Medical Centre (Netherlands) - Department of Obstetrics & Gynecology

Who is the main contact?
Josien Penninx MD, josienp@hotmail.com
Marlies Bongers MD PhD, m.bongers@mmc.nl

Trial website

Contact information

Type

Scientific

Primary contact

Miss Josien Penninx

ORCID ID

Contact details

De Run 4600
Veldhoven
5500 MB
Netherlands
+31 (0)40 888 8388
j.penninx@mmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Bipolar radiofrequency endometrial ablation versus balloon endometrial ablation in women with dysfunctional uterine bleeding in the office: a multi-centre randomized controlled trial

Acronym

NOTE

Study hypothesis

NOTE [NOvasure versus ThErmablate]

The balloon endometrial ablation (Thermablate) will give a 30% amenorrhea rate and will be acceptable to undergo with only local anesthesia. The bipolar radiofrequency endometrial ablation (Novasure) will be the gold standard.

The null hypothesis is that there is no difference in amenorrhea rate between both groups.

Ablation techniques in the office: The endometrial ablation procedures were performed in the outpatient clinic with local anesthesia (paracervical block) and not in the operating room.

Ethics approval

Medical Ethics Committee Maxima Medical Centre, Veldhoven, February 2009, Ref. : 813

Study design

Multi-centre double-blind randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Endometrial ablation in women with menorrhagia

Intervention

Bipolar endometrial ablation (NovaSure) versus balloon endometrial ablation (Thermablate).

The total duration of treatment was about 5 to 45 minutes, mean: 11 minutes.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The number of women with amenorrhea measured at 6 weeks, 6 months and 12 months after treatment, scored (zero) on a pictorial chart menstruation score.

Secondary outcome measures

1. Painscores: Visual analogue scales were used to measure pain during the procedure when dilating the cervix, during the endometrial ablation, and at 1, 4, 12 and 24 hours after the procedure
2. Reduction in menstrual bleeding : measured by a pictorial chart score at baseline and at each follow up visit at 6 weeks, 6 months and 12 months after the endometrial ablation
3. Patient satisfaction : asked at each follow up visit at 6 weeks, 6 months and 12 months after the procedure ( completely satisfied, satisfied, doubtful, unsatisfied)
4. Re-interventions: measured at 6 weeks, 6 months and12 months after the endometrial ablation
5. Quality of life: measured with a Shaw questionnaire (multi attribute utility menstruation scale) at baseline, and each follow up visit at 6 weeks, 6 months and 12 months follow up

Overall trial start date

01/03/2009

Overall trial end date

01/02/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women (aged 34 to 55 years) with menorrhagia ( > 150 points on Higham pictorial chart score)
2. Normal uterine cavity (confirmed by saline infusion sonography or hysteroscopy)
3. Normal Pap smear
4. A premenopausal follicular stimulating hormone (FSH)-level of less than 40 IU/I

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

104

Participant exclusion criteria

1. Presence of coagulopathies
2. Use of anti-coagulants
3. A desire to preserve fertility
4. Prior uterine surgery, other than low segment Caesarean section
5. Suspected or confirmed uterine malignancy
6. Intra cavitairy pathology, except polyps < 1cm

Recruitment start date

01/03/2009

Recruitment end date

01/02/2013

Locations

Countries of recruitment

Netherlands

Trial participating centre

De Run 4600
Veldhoven
5500 MB
Netherlands

Sponsor information

Organisation

Maxima Medical Center (Netherlands)

Sponsor details

PO Box 777
Veldhoven
5500 MB
Netherlands
+31 (0)40 888 8384
m.bongers@mmc.nl

Sponsor type

Hospital/treatment centre

Website

http://www.mmc.nl/

Funders

Funder type

Hospital/treatment centre

Funder name

Maxima Medical Centre (Netherlands) - Department of Obstetrics & Gynecology

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes