| Methods |
Parallel randomised controlled trial |
| Participants |
Premenopausal women + HMB (AH > 160 mL/cycle)
Inclusion criteria:
Premenopausal (follicle‐stimulating hormone level % 40 mIU/mL) Between 25 and 50 years of age Have completed childbearing To provide AH documented evidence of HMB (PALM‐COEIN: E, O). minimum bleeding level 160 mL per cycle (for 1 cycle) to qualify for study participation Uterine sounding length limited to maximum 10 cm Agree to not use any hormonal birth control to eliminate the possibility of post‐treatment bleeding reduction induced by the suppressive action of hormonal contraceptives
Exclusion criteria:
Evidence of pelvic inflammatory disease Active/acute endometritis Sexually transmitted infection Bacteraemia, sepsis, other active local and/or systemic infection Untreated/unevaluated cervical dysplasia (except CIN I) Endometrial hyperplasia Known or suspected abdominal or pelvic cancer Coagulopathies Anticoagulation therapy Congenital malformations of the uterus Hysteroscopically or ultrasonographically confirmed fibroid(s) distorting the uterine Cavity Endometrial polyp(s) larger than 2 cm Less than 6 weeks' postpartum History of prior uterine surgery (except low‐segment cesarean delivery) Previous endometrial ablation Having implantable contraceptive device Medications that could thin the myometrial muscle such as long‐term steroid use (except inhaler or nasal therapy for asthma)
Setting: academic and private medical settings (USA, Canada, and Mexico)
Timing: not specified |
| Interventions |
Bipolar endometrial ablation (Minerva) (n = 102)
Rollerball endometrial ablation (n = 51) |
| Outcomes |
Menstrual blood loss: success (AH < 80 mL) Amenorrhoea rate at 12 months Satisfaction Surgery duration (minutes) Safety in terms of adverse effects Requirement for further surgery or medical treatment Dysmenorrhoea reduction PMS reduction |
| Notes |
Funding: sponsored by Minerva Surgical Inc.
Conflicts of interest: study authors declare that they have no conflicts of interest |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Women were block randomised from a centralised electronic patient database in a 2:1 scheme to the test group or the control group, but no details were provided |
| Allocation concealment (selection bias) |
Unclear risk |
No details on allocation |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
No details in the paper, but on the clinical trial register says "open label" |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Not mentioned |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Only 6.5% dropout after 1 year; used ITT analysis for all participants |
| Selective reporting (reporting bias) |
Low risk |
All prespecified outcomes were reported |
| Other bias |
Low risk |
Groups are balanced at baseline; no other sources of bias were identified |
