Condition category
Urological and Genital Diseases
Date applied
12/09/2005
Date assigned
12/09/2005
Last edited
27/10/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr J. Kleijn

ORCID ID

Contact details

Maxima Medisch Centrum
Locatie Veldhoven
P.O. Box 7777
Veldhoven
5500 MB
Netherlands
+31 (0)40 8888000
J.Kleijn@mmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Demonstrate that the HydroThermAblation procedure is equally effective compared to the Novasure procedure in achieving patent satisfaction at twelve months post-treatment for menorrhagia secondary to DUB.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Dysfunctional uterine bleeding

Intervention

Hydrothermablator (HTA) System versus ablation with Novasure

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Patients satisfaction:
At each follow up visit/telephone call patients satisfaction was noted. Patients can express their level satisfaction by using - completely satisfied, satisfied, doubtful satisfied or not satisfied.
It is also noted if any kind of reintervention is performed, such as the use of oral contraceptives or surgery.

Secondary outcome measures

1. Quality of life: all patients are asked to complete quality of life questionnaires at baseline, at two days, six weeks, three months, six months and twelve months after surgery. We evaluate quality of life with the medical outcomes study SF 36, the Rotterdam symptom checklist and a structured clinical history questionnaire.
2. Amennorhoea: at each follow up visit/ telephone call duration of menstruation, dysmennorhoea and presence of clots are registered. Patients also complete a pictorial chart.

Overall trial start date

01/03/2005

Overall trial end date

01/08/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Refractory menorrhagia with no definable organic cause (dysfunctional uterine bleeding).
2. Age over 25 years old
3. Uterine sound measurement of 6.0 - 12 cm (external os to internal fundus).
4. Failed, contraindicated or intolerance to conservative (medical) therapy.
5. Menstrual Diary:
A minimum PBLAC score of > 150 for 1 month. Intracavitary pathology, such as type 2 fibromas and small polyps (≤ 2cm), confirmed by hysteroscopy or Saline Infused Sonography (SIS)

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

160

Participant exclusion criteria

1. Presence of bacteremia, sepsis, or other active systemic infection
2. Active or recurrent chronic pelvic inflammatory disease
3. Patients with documented coagulopathies
4. Symptomatic endometriosis
5. Prior uterine surgery (except low segment cesarean section) which interrupts the integrity of the uterine wall e.g.transmural myomectomy or classical cesarean section. Prior endometrial ablations.
6. Patients on medications that could thin the myometrial muscle, such as long-term steroid use.
7. Patients on anticoagulants.
8. Desire to have children or to preserve fertility
9. Patients currently on hormonal birth control therapy or unwilling to use a non-hormonal birth control post-ablation.
10. Abnormal/Obstructed Cavity as confirmed by hysterscopy, Saline Infused Sonography (SIS) or HSG. Specifically: Septate or bicornuate uterus or other congenital malformation of the uterine cavity.

Recruitment start date

01/03/2005

Recruitment end date

01/08/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Maxima Medisch Centrum
Veldhoven
5500 MB
Netherlands

Sponsor information

Organisation

Maxima Medisch Centrum (The Netherlands)

Sponsor details

Locatie Veldhoven Postbus 7777
Veldhoven
5500 MB
Netherlands
+31 (0)40 8888000
info@mmc.nl

Sponsor type

Hospital/treatment centre

Website

http://www.mmc.nl/

Funders

Funder type

Hospital/treatment centre

Funder name

Máxima Medisch Centrum (Netherlands)

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

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20859144

Publication citations

  1. Results

    Penninx JP, Mol BW, Engels R, van Rumste MM, Kleijn C, Koks CA, Kruitwagen RF, Bongers MY, Bipolar radiofrequency endometrial ablation compared with hydrothermablation for dysfunctional uterine bleeding: a randomized controlled trial., Obstet Gynecol, 2010, 116, 4, 819-826, doi: 10.1097/AOG.0b013e3181f2e3e3.

Additional files

Editorial Notes