Quality of Life After Hysterectomy (AdenoQOL)

Sponsor
Oslo University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04791033
Collaborator
(none)
218
1
116.5
1.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Hysterectomy

Study Design

Study Type:
Observational
Anticipated Enrollment :
218 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Quality of Life After Hysterectomy for Adenomyosis and Other Benign Gynecological Conditions
Actual Study Start Date :
Mar 18, 2021
Anticipated Primary Completion Date :
Oct 30, 2022
Anticipated Study Completion Date :
Dec 1, 2030

Arms and Interventions

Arm Intervention/Treatment
Adenomyosis

Patients with adenomyosis

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

Other benign gynecological conditions

Patients with other benign gynecological conditions (i.e: myomas, endometriosis).

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 52 Years
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Marianne Omtvedt Oslo Norway

Sponsors and Collaborators

  • Oslo University Hospital

Investigators

  • Principal Investigator: Marianne Omtvedt, MD, Oslo University Hospital
  • Study Director: Tina Tellum, PhD, Oslo University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marianne Omtvedt, Principal Investigator, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT04791033
Other Study ID Numbers:
  • 213906
First Posted:
Mar 10, 2021
Last Update Posted:
Apr 20, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Marianne Omtvedt, Principal Investigator, Oslo University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 20, 2022