Quality of Life After Hysterectomy (AdenoQOL)

Study Overview
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Brief Summary
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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.

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

Conditions
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Adenomyosis, Quality of Life

Intervention / Treatment
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* Procedure: Hysterectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 52 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adenomyosis<br>Patients with adenomyosis | Procedure: Hysterectomy<br>* Elective procedure with hysterectomy due to benign gynecological condition<br>|
| Other benign gynecological conditions<br>Patients with other benign gynecological conditions (i.e: myomas, endometriosis). | Procedure: Hysterectomy<br>* Elective procedure with hysterectomy due to benign gynecological condition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The impact of hysterectomy on health related quality of life assessed by SF-36 sub scale bodily pain | The 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The impact of hysterectomy on health related quality of life assessed by SF-36 sub scales | The 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. | 5 years | 
| The impact of hysterectomy on health related quality of life assessed by SF-36 eight subscales | The 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. | 5 years | 
| The impact of hysterectomy on sexual function assessed by FSFI | The 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. | 1 year | 
| The impact of hysterectomy on sexual function assessed by FSFI | The 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. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hysterectomy, Sexual Health, Adenomyosis