Clinical trial NCT04791033: Quality of Life After Hysterectomy (AdenoQOL)
Official title: Quality of Life After Hysterectomy for Adenomyosis and Other Benign Gynecological Conditions
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Adenomyosis
Quality of Life
Keywords: Hysterectomy
Sexual Health
Adenomyosis
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 218
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 52
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A consecutive sample of women that are scheduled for hysterectomy at the study site, who fulfill eligibility criteria, are invited to participate

Brief summary: Adenomyosis is a disease where ectopic endometrial-like glands affect the muscular wall of the uterus. About 70% of women affected by adenomyosis suffer from dysmenorrhea and menorrhagia. A levonorgestrel-releasing intrauterine device (LNG-IUD) is the first-choice treatment of adenomyosis, but is not always sufficiently effective in all women. Those women often end up removing the uterus (hysterectomy).

Hysterectomy is clinically regarded to be an efficient and final treatment of adenomyosis, but pelvic pain may also prevail after removal of the uterus. This study aimes to investigate the short - and long-term impact of hysterectomy on quality of life (QOL) and sexual function in women with adenomyosis, and further to evaluate if there is any difference compared to women that are removing their uterus due to other benign gynecological conditions.


Eligibility criteria: Inclusion Criteria:

* Premenopausal status defined by having had menstruation within the last 12 months, or age \< 50 years if amenorrhea due to hormonal treatment
* Hysterectomy planned due to a benign condition
* Able to communicate in Norwegian or English
* Electronic consent given

Exclusion Criteria:

* Age \< 18 years, postmenopausal status or no menstrual bleeding for the last 12 months
* Hysterectomy as part of female-to-male transition
* Pelvic organ prolapse as an indication for hysterectomy
* Gynecological cancer suspected at the time of inclusion
* Not able to communicate in Norwegian or English

Primary outcomes:
measure: The impact of hysterectomy on health related quality of life assessed by SF-36 sub scale bodily pain
timeFrame: 1 year
Secondary outcomes:
measure: The impact of hysterectomy on health related quality of life assessed by SF-36 sub scales
timeFrame: 5 years
measure: The impact of hysterectomy on health related quality of life assessed by SF-36 eight subscales
timeFrame: 5 years
measure: The impact of hysterectomy on sexual function assessed by FSFI
timeFrame: 1 year
measure: The impact of hysterectomy on sexual function assessed by FSFI
timeFrame: 5 years
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Marianne Omtvedt
Study officials:
affiliation: Oslo University Hospital
name: Marianne Omtvedt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oslo University Hospital
name: Tina Tellum, PhD
role: STUDY_DIRECTOR
References: