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Active, Not Recruiting

NCT Number: NCT04791033

Quality of Life After Hysterectomy (AdenoQOL)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Adenomyosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Quality of Life Urogenital Diseases Uterine Diseases

Age range

18 year–52 year

Sex eligibility

Female

Study type

Observational

Primary location

Marianne Omtvedt

Oslo, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hysterectomy

Procedure

Elective procedure with hysterectomy due to benign gynecological condition

Primary outcomes

  1. The impact of hysterectomy on health related quality of life assessed by SF-36 sub scale bodily pain

    Time frame: 1 year

    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.

Secondary outcomes

  1. The impact of hysterectomy on health related quality of life assessed by SF-36 sub scales

    Time frame: 5 years

    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.

  2. The impact of hysterectomy on health related quality of life assessed by SF-36 eight subscales

    Time frame: 5 years

    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.

  3. The impact of hysterectomy on sexual function assessed by FSFI

    Time frame: 1 year

    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.

  4. The impact of hysterectomy on sexual function assessed by FSFI

    Time frame: 5 years

    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.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2030
First posted
Mar 10, 2021
Registry last updated
Apr 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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