Quality of Life After Hysterectomy (AdenoQOL)

April 18, 2024 updated by: Marianne Omtvedt, Oslo University Hospital

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

218

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway
        • Marianne Omtvedt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 52 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

A consecutive sample of women that are scheduled for hysterectomy at the study site, who fulfill eligibility criteria, are invited to participate

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

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
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.
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
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.
5 years
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.
5 years
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.
1 year
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2021

Primary Completion (Actual)

October 30, 2022

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

March 5, 2021

First Submitted That Met QC Criteria

March 5, 2021

First Posted (Actual)

March 10, 2021

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 213906

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will share the values of the quality of life data.

IPD Sharing Time Frame

The data is planned to be made available within a year after the publication of all results.

IPD Sharing Access Criteria

Access will be granted upon request and evaluation of the intended use of the data. The intended use should primarily gain improved patient care and research into quality of life after hysterectomy and a detailed protocol has to be submitted.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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