A randomised controlled trial comparing endometrial ablation plus levonorgestrel releasing intrauterine system versus endometrial ablation alone in women with heavy menstrual bleeding.

Rationale
Heavy menstrual bleeding (HMB) is a frequent problem affecting 1 in 4 women between 30 and 50 years. Endometrial ablation (EA) is a widely used procedure to treat HMB. However, 12-25% of women are dissatisfied after EA because of persisting abnormal uterine bleeding (AUB) and/or dysmenorrhea and most of these symptomatic women ultimately undergo a hysterectomy.
Adding a levonorgestrel releasing intrauterine system (LNG-IUS) inactivates the residual or regenerative endometrial tissue. This will reduce the pre-existing cyclical pelvic ‘period’ pain and minimise or eradicate iatrogenic pelvic pain induced by intrauterine adhesion formation associated with endometrial ablative treatment. Although, adding a LNG-IUS is not usual care for heavy menstrual bleeding treatment.
We hypothesize that the combination of endometrial ablation and LNG-IUS is superior to endometrial ablation alone in terms of substantially reducing subsequent rates of hysterectomy and alleviating pain and heavy menstrual bleeding.

Objective
To determine whether the introduction of a LNG-IUS directly after endometrial ablation (EA) reduces the need for subsequent hysterectomy and alleviates pain and heavy menstrual bleeding compared with endometrial ablation alone.

Study design
Multicentre randomized controlled trial.

Study population
Women suffering from heavy menstrual bleeding without contraindications for use of the LNG-IUS who opt for treatment with EA.

Intervention
Endometrial ablation and LNG-IUS combined.

Usual Care / comparison
Endometrial ablation alone

Main study parameters / endpoints
Primary: hysterectomy rate after 2 years of follow-up.
Secondary: patient satisfaction, PBAC-score, quality of life, cyclic and non-cyclic pelvic pain, re-interventions, complications, side-effects and cost-effectiveness.

The hypothesis is that the combination of endometrial ablation and LNG-IUS is superior to endometrial ablation alone in terms of substantially reducing subsequent rates of hysterectomy within two year after treatment with 7%.

At baseline, after 6, 12, 18 en 24 months

Endometrial ablation and LNG-IUS combined.