This study aims to evaluate the impact of UAE on Quality of life (QOL) in comparison to hysterectomy in adenomyosis patients.
ID
Source
Brief title
Health condition
Adenomyosis is defined as the benign invasion of endometrial stroma and glands in the myometrium, surrounded by hypertrophic and hyperplastic myometrium. Today adenomyosis still poses a gynaecological challenge. There are differences in opinion and thus differences in definition, diagnosing as well a treatment options. Adenomyosis is frequently suspected in patients with abnormal uterine bleeding and dysmenorrhea and diagnosed in the uterine specimen of patients with presumed uterine fibroids. Study population:Premenopausal women without the desire to conceive and who have symptomatic MRI confirmed pure adenomyosis or dominant adenomyosis in combination with fibroids.(If the deep fibroids are clearly less to the extent of adenomyosis in terms of volume we consider it dominant adenomyosis)
Sponsors and support
Sponsors:
2015-2018: Celonova Biosciences
2019-2021: Merit medical
Intervention
Outcome measures
Primary outcome
• Quality of life:
To demonstrate non inferiority of treatment of adenomyosis with uterine artery embolization compared to treatment by hysterectomy in terms of quality of life at 26, 52 and 104 weeks after treatment (measured by WHOQOL-Bref and SF-12)
Secondary outcome
The two treatments will also be compared in terms of:
• Clinical outcomes (PBAC, NRS 0-100 scale, Facet 1:Pain and discomfort WHOQOL-100, Satisfaction with allocated treatment (likert-scale), patient preference)
• Recovery related outcomes (RI-10)
• Quality of life outcomes (HOQOL-Bref and SF-12)
• Cost outcomes (EQ-5D)
• Imaging outcomes (uterine size reduction, infarction rate, junctional zone reduction, concomitant fibroids)
Background summary
Adenomyosis is defined as the benign invasion of endometrial stroma and glands in the myometrium, surrounded by hypertrophic and hyperplastic myometrium. Hysterectomy is established as the final treatment option when conservative treatment fails. Case series for UAE (uterine artery embolization) in adenomyosis patients show promising results. However, a randomized controlled trial is lacking.
Objective of the study:
This study aims to evaluate the impact of UAE on Quality of life (QOL) in comparison to hysterectomy in adenomyosis patients. A cost-effectiveness study will be part of the trial as well as a cohort hysterectomy group to clearify imaging and diagnosis of adenomyosis. The original protocol described a randomized controlled trial where eligible patients (not changed) were randomized to either hysterectomy or UAE in a 1:2 ratio. Inclusion rates were disappointing, resulting in very low progress of the trial. Therefore a new design was chosen: a case-control design with retrospective matching (or correction of baseline variables if not identical at baseline).
Study design:
2015-2018: Non-blinded randomized controlled trial and cohort alongside the trial. 2018-2021: case-control cohort study
Study population:
Premenopausal women without the desire to conceive and who have symptomatic MRI confirmed pure adenomyosis or dominant adenomyosis in combination with fibroids. (If the deep fibroids are clearly less to the extent of adenomyosis in terms of volume we consider it dominant adenomyosis)
Intervention (if applicable):
UAE, performed by experienced interventional radiologists versus hysterectomy (laparoscopically, abdominally or vaginally).
Primary study parameters/outcome of the study:
Primary endpoint: quality of life as measured by a combination of the World Health Organization Quality-of-Life Scale (WHOQOL-Bref) and short-form-12 (SF-12) questionnaire at 26 weeks after therapy.
Secundary study parameters/outcome of the study (if applicable):
The two treatments will also be compared in terms of Clinical outcomes, Recovery related outcomes, Quality of life outcomes and cost outcomes. Also imaging outcomes will be investigated at baseline in order to identify potential predictive parameters for therapy effect.
Study objective
This study aims to evaluate the impact of UAE on Quality of life (QOL) in comparison to hysterectomy in adenomyosis patients.
Study design
Measurements: will be taken at baseline and 6, 12, 26, 52 and 104 weeks after therapy.
Intervention
Uterine artery embolization -> experimental treatment
Hysterectomy -> standard care
Marissa Harmsen
VUmc – afdeling Gynaecologie & Verloskunde Instituut – ICaR-VU
Amsterdam
The Netherlands
T: +3120 44 44833/ +31683674927
m.harmsen1@amsterdamumc.nl
Marissa Harmsen
VUmc – afdeling Gynaecologie & Verloskunde Instituut – ICaR-VU
Amsterdam
The Netherlands
T: +3120 44 44833/ +31683674927
m.harmsen1@amsterdamumc.nl
Inclusion criteria
• Premenopausal women with MRI confirmed symptomatic adenomyosis or dominant adenomyosis in combination with fibroids.
• Premenopausal women with an indication for hysterectomy.
• No wish to conceive in the present or future
• Able to understand Dutch language.
Exclusion criteria
• Younger than 18 years of age
• Pelvic infection/Suspicion or presence of malignancy
• Current pregnancy
• Contra-indication for angiography (such as contrast fluid allergy, coagulopathy and renal failure), when not treatable
• Deep infiltrating endometriosis requiring surgery or with risks on intestinal stenosis
• Concurrent removable submucous fibroids (Patients eligible after removal)
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 | NL5471 |
| NTR-old | NTR5615 |
| CCMO | NL52652.029.15 |
| OMON | NL-OMON55436 |