AdenomyosisNCT04791033
Quality of Life After Hysterectomy (AdenoQOL)
An observational study of Adenomyosis and Quality of Life, run by Oslo University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 52 years, women only
- Conditions the study is for
- Adenomyosis, Quality of Life
- What is being tested?
- Hysterectomy
- Type of treatment
- Surgery or procedure
- How many people
- 218 participants
- Where
- 1 siteNorway
- Study dates
- 18 Mar 2021to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 52 years
- Women only
- No healthy volunteers
- Adult
Study population: A consecutive sample of women that are scheduled for hysterectomy at the study site, who fulfill eligibility criteria, are invited to participate
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Adenomyosis, Quality of Life
- Being tested
- Hysterectomy
- Keywords
- Hysterectomy, Sexual Health, Adenomyosis
- Medical subject headings
- Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HysterectomyProcedure or surgery
Elective procedure with hysterectomy due to benign gynecological condition
| Study group | Role | What they receive |
|---|---|---|
| Adenomyosis | Patients with adenomyosis Receives: Procedure: Hysterectomy | |
| Other benign gynecological conditions | Patients with other benign gynecological conditions (i.e: myomas, endometriosis). Receives: Procedure: Hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start18 Mar 2021
- Primary completion30 Oct 2022
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenomyosisStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marianne Omtvedt, Oslo University Hospital
- Investigators
- Marianne Omtvedt, MD, Principal investigator, Oslo University HospitalTina Tellum, PhD, Study director, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791033
- Sponsor's protocol ID
- 213906
- Status last verified
- Apr 2024
- First submitted
- 5 Mar 2021
- Last updated
- 19 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share the values of the quality of life data.
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life After Hysterectomy for Adenomyosis and Other Benign Gynecological Conditions
- ClinicalTrials.gov ID
- NCT04791033
- Acronym / sponsor ID
- 213906
- Conditions
- Adenomyosis, Quality of Life
- Keywords
- Hysterectomy, Sexual Health, Adenomyosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- Dec 2030 (estimated)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adenomyosis | – | Procedure: HysterectomyPatients with adenomyosis |
| Other benign gynecological conditions | – | Procedure: HysterectomyPatients with other benign gynecological conditions (i.e: myomas, endometriosis). |
Who may qualify
- Ages
- 18 to 52 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- A consecutive sample of women that are scheduled for hysterectomy at the study site, who fulfill eligibility criteria, are invited to participate
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HysterectomyElective procedure with hysterectomy due to benign gynecological condition | Procedure or surgery | Adenomyosis, Other benign gynecological conditions |
Primary outcome
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.
4 secondary outcomes
The impact of hysterectomy on health related quality of life assessed by SF-36 sub scales
Time frame: 5 years
The impact of hysterectomy on health related quality of life assessed by SF-36 eight subscales
Time frame: 5 years
The impact of hysterectomy on sexual function assessed by FSFI
Time frame: 1 year
The impact of hysterectomy on sexual function assessed by FSFI
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Individual participant dataSharing planned: Yes. We will share the values of the quality of life data.
Related trials for Adenomyosis
Not yet recruiting
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
Not yet recruitingObservational study
Linzagolix in Adenomyosis and Recurrent Implantation Failure
Adenomyosis of Uterus, Implantation Failure
RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Adenomyosis of Uterus
Recruiting
Stellate Ganglion Block and Dexmedetomidine for Postoperative Sleep in Women Undergoing Laparoscopic Gynecologic Surgery
Uterine Fibroids (Leiomyoma), Adenomyosis of Uterus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marianne Omtvedt, MD principal investigator
Oslo University Hospital
Tina Tellum, PhD study director
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenomyosis and Quality of Life, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The impact of hysterectomy on health related quality of life assessed by SF-36 sub scale bodily pain (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.