ISRCTN ISRCTN23845359
DOI https://doi.org/10.1186/ISRCTN23845359
Secondary identifying numbers N/A
Submission date
12/09/2005
Registration date
12/09/2005
Last edited
27/10/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr J. Kleijn
Scientific

Maxima Medisch Centrum
Locatie Veldhoven
P.O. Box 7777
Veldhoven
5500 MB
Netherlands

Phone +31 (0)40 8888000
Email J.Kleijn@mmc.nl

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesDemonstrate 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedDysfunctional uterine bleeding
InterventionHydrothermablator (HTA) System versus ablation with Novasure
Intervention typeOther
Primary outcome measurePatients 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 measures1. 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 study start date01/03/2005
Completion date01/08/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexNot Specified
Target number of participants160
Key inclusion criteria1. 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)
Key exclusion criteria1. 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.
Date of first enrolment01/03/2005
Date of final enrolment01/08/2007

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Maxima Medisch Centrum
Veldhoven
5500 MB
Netherlands

Sponsor information

Maxima Medisch Centrum (The Netherlands)
Hospital/treatment centre

Locatie Veldhoven Postbus 7777
Veldhoven
5500 MB
Netherlands

Phone +31 (0)40 8888000
Email info@mmc.nl
Website http://www.mmc.nl/
ROR logo "ROR" https://ror.org/02x6rcb77

Funders

Funder type

Hospital/treatment centre

Máxima Medisch Centrum (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/10/2010 Yes No