Quality of Life After Hysterectomy (AdenoQOL)

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04791033
• Other study ID #: 213906
• Status: Active, not recruiting
• Start date: March 18, 2021
• Est. completion date: December 2030

Study information

• Verified date: April 2024
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 218
• Est. completion date: December 2030
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 52 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenomyosis
• Quality of Life

Intervention

Procedure:
• Hysterectomy
Elective procedure with hysterectomy due to benign gynecological condition

Locations

Country	Name	City	State
Norway	Marianne Omtvedt	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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