No registrations found.
ID
Source
Brief title
Health condition
Heavy menstrual bleeding
Dysmenorroea
Sponsors and support
Intervention
Outcome measures
Primary outcome
Hysterectomy rate after 2 years of follow-up.
Secondary outcome
Patient satisfaction, PBAC-score, quality of life, cyclic and non-cyclic pelvic pain, re-interventions, complications, side-effects and cost-effectiveness.
Background summary
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.
Study objective
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%.
Study design
At baseline, after 6, 12, 18 en 24 months
Intervention
Endometrial ablation and LNG-IUS combined.
Inclusion criteria
Women suffering from heavy menstrual bleeding, who do not wish or benefit from another treatment for heavy menstrual bleeding (medication or LNG-IUS) and opt for treatment with EA, irrespective of the existence of fibroids, polyps or adenomyosis. Earlier use of LNG-IUS is no exclusion.
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 who might want to get pregnant in the future will not be included since an endometrium ablation interferes with future pregnancies.
• Suspicion on endometrial cancer.
• Contra-indications for levonorgestrel IUD.
• Already performed Eandometrial Ablation.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7817 |
| CCMO | NL69895.015.19 |
| OMON | NL-OMON54839 |