Multicentre study comparing two endometrial ablation techniques in the office: bipolar endometrial ablation versus balloon endometrial ablation

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17974690

Enrollment

104

Registered

2013-02-11

Start date

2009-03-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial ablation in women with menorrhagia Urological and Genital Diseases Excessive bleeding in the premenopausal period

Interventions

Bipolar endometrial ablation (NovaSure) versus balloon endometrial ablation (Thermablate). The total duration of treatment was about 5 to 45 minutes, mean: 11 minutes.

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026