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Quality of Life After Hysterectomy (AdenoQOL)

Quality of Life After Hysterectomy for Adenomyosis and Other Benign Gynecological Conditions

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04791033
Enrollment
218
Registered
2021-03-10
Start date
2021-03-18
Completion date
2030-12-31
Last updated
2024-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenomyosis, Quality of Life

Keywords

Hysterectomy, Sexual Health, Adenomyosis

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.

Interventions

PROCEDUREHysterectomy

Elective procedure with hysterectomy due to benign gynecological condition

Sponsors

Oslo University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 52 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The impact of hysterectomy on health related quality of life assessed by SF-36 sub scale bodily pain1 yearThe Short Form Health Survey (SF-36) measures eight sub scales including bodily pain (BP) which in this study is used as primary outcome. The scales ranges from 0-100, a higher score indicates a better quality of life.

Secondary

MeasureTime frameDescription
The impact of hysterectomy on health related quality of life assessed by SF-36 sub scales5 yearsThe Short Form Health Survey (SF-36) measures eight subscales. In this study seven sub scales is used as secondary outcomes: Physical functioning (PF), role physical (RP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE) and mental health (MH). The scales ranges from 0-100, a higher score indicates a better quality of life.
The impact of hysterectomy on health related quality of life assessed by SF-36 eight subscales5 yearsThe Short Form Health Survey (SF-36) measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). The scales ranges from 0-100, a higher score indicates a better quality of life.
The impact of hysterectomy on sexual function assessed by FSFI1 yearThe Female Sexual Function Index (FSFI) use a 5-point Likert scale ranging from 1-5 with higher scores indicating greater levels of sexual functioning. To score the measure the sum of each domain score (sexual desire, arousal, lubrication, orgasm, satisfaction and pain) is multiplied by a domain factor and summed to derive a total FSFI score.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026