To determine whether the introduction of a levonorgestrel-releasing intrauterine system (LNG-IUS) directly after endometrial ablation (EA) alleviates pain and heavy menstrual bleeding and reduces the need for subsequent hysterectomy compared with…
ID
Source
Brief title
Condition
- Menstrual cycle and uterine bleeding disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary: hysterectomy rate after 2 years of follow-up.
Secondary outcome
Patient satisfaction, PBAC-score, quality of life, cyclisch and non-cyclic
pelvic pain, side-effects, re-interventions, complications and
cost-effectiveness.
Background summary
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.
Study objective
To determine whether the introduction of a levonorgestrel-releasing
intrauterine system (LNG-IUS) directly after endometrial ablation (EA)
alleviates pain and heavy menstrual bleeding and reduces the need for
subsequent hysterectomy compared with endometrial ablation alone.
Study design
Multicentre randomized controlled trial.
Intervention
Endometrial ablation and LNG-IUS combined, control group is standard care with
only an endometrial ablation.
Study burden and risks
This study investigates a combined treatment. However, whilst EA and LNG-IUS
both are widely implemented as individual treatments, a combination of the two
is seldom used for heavy menstrual bleeding. Perforation of the uterus is a
small risk during or after insertion of a LNG-IUS. In a cohort study of
Heineman et al. (n = 61.448), 1.4 uterine perforations were reported per 1000
patients who received a LNG-IUS. Patients will fill in 5 questionnaires in a
period of 24 months. This will not impose extra risk on participants.
De Run 4600
Veldhoven 5504DB
NL
De Run 4600
Veldhoven 5504DB
NL
Listed location countries
Age
Inclusion criteria
Women suffering from heavy menstrual bleeding, who opt for treatment with EA,
irrespective of the existence of fibroids, polyps or adenomyosis.
Exclusion criteria
- Women who don*t speak Dutch or English to a standard that they can fully
understand the study and complete the trial questionnaires.
- Women with a (future) childwish
- Women with a suspicion on endometrial cancer.
- Women with contra-indications for levonorgestrel IUD.
- Women with an already performed Endometrial Ablation.
- Women over 60 years old.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL69895.015.19 |
| Other | NL7817 |
| OMON | NL-OMON25628 |