- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02511626
Quality of Life in Endometriosis - a Case Control Study
Quality of Life in Endometriosis - a Case Control Study Using Internationally Validated Questionnaires
Endometriosis, one of the most common diseases of women during their reproductive period., may present a chronic disabling disease with major impact on women's life. Therapeutic options are limited and recurrence of disease symptoms is frequent.
The current study investigates the quality of life and several risk factors for the development of endometriosis as well as satisfaction with medical support in a minimum of 600 women with different stages of endometriosis and the same number of control women matched for age (± 3 years) and nationality. To evaluate specific features of endometriosis-associated pain a second group of 100 women with chronic abdominal/pelvic pain not related to endometriosis is investigated. Recruitment takes place in different university clinics, and districts hospitals in Switzerland, Germany. And Austria. Control women i.e. women without any evidence for endometriosis presenting for annual routine gynaecological controls are collected at the same places.
A composition of different internationally validated questionnaires as well as specific questions on dealing with endometriosis is used to collect information on the quality of life and potential risk factors for endometriosis. Questions on sexuality and partnership are also distributed to women's partners. All diagnosis of endometriosis and classification of ASRM (American Society for Reproductive Medicine) disease stages are based on woman's medical charts.
Study Overview
Status
Detailed Description
With a prevalence of 7-10% endometriosis is one of the most common diseases of women during their reproductive period. There is a broad range of clinical symptoms of endometriosis, which may vary between an incidental asymptomatic finding and a chronic severely painful disease. Symptoms are nearly independent from disease stage and current therapeutic options do not permit to reliably reduce symptoms to an acceptable level. Independent from the therapy chosen, about 20% of women re-develop clinical symptoms in the first year and another 50% within a period of five years.
The currently provided medical support concentrates on surgical and medical i.e. hormonal options. Although it seems evident that endometriosis-associated pain will have a serious impact on the daily life of women attaint and there is a broad literature on the effect of other chronic pain diseases on patients' lives, comparable data for endometriosis are rare. Also, support models to allow women to integrate a chronic endometriosis into their daily life are currently lacking. To provide a reliable basis for the development of better holistic support models, the current study collects data on different aspects of the quality of life in a minimum of 600 women with different stages of endometriosis and a minimum of 600 control women matched for age (± 3 years) and nationality. To evaluate which features of the quality of life are specific for endometriosis a second control group of 100 women with chronic abdominal/pelvic pain not related to endometriosis is investigated. Recruitment takes place in different university clinics, and districts hospitals in Switzerland, Germany and Austria. Control women i.e. women without any evidence for endometriosis presenting for annual routine gynaecological controls are collected at the same places.
A composition of different internationally validated questionnaires as well as specific questions on dealing with endometriosis is used to collect information on the quality of life and potential risk factors for endometriosis. The questionnaire includes basic socio-demographic data, life style parameters, a general as well as gynaeco-obstetric history including detailed questions on the diagnosis, treatment and current symptoms of endometriosis. In addition questionnaires on pain (modified version of the Brief Pain Inventory (BPI), Pain Disability Index (PDI), resources (SOC), stress perception (PSQ20), professional development, satisfaction with medical support, adverse childhood experiences (modified version of the childhood trauma questionnaire (CTQ), daily life, partnership (Partnerschaftsfragebogen, PFB), sexuality (modified version of the Brief Index of Sexual Functioning and Global sexual functioning) and anxiety/depression (PHQ, GAD) have to be completed by study participants. Socio-demographic questions, questions on partnership as well as on the estimated impact of endometriosis on partnership /sexuality were also given to study participants' partners. In addition to the current quality of life potential risk factors for the development of endometriosis e.g. traumatic childhood experiences are evaluated as well as satisfaction with medical support are evaluated.
All diagnosis of endometriosis and classification of ASRM disease stages are based on woman's medical charts.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Zurich, Switzerland, 8091
- Clinic for Reproductive Endocrinology, University Hospital Zurich
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Female Age >18
Case group: women with endometriosis Healthy volunteers in control group
Description
Inclusion Criteria:
female >18 years fluent German
- Cases: diagnosis of endometriosis Control 1: no endometriosis, no chronic pain Control 2: no endometriosis, chronic abdominal/pelvic pain
Exclusion Criteria:
- male (Except for partner questionnaires)
- <18years
- not fluent in German
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Case group
Women with a surgically confirmed diagnosis of endometriosis
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Control group 1
Women without any evidence of endometriosis (= no clinical symptom and/or no surgical evidence of endometriosis)
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Control group 2
Women without endometriosis (surgically confirmed) but chronic abdominal/pelvic pain due to other reasons (e.g.
Crohn's disease, colitis etc)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life i.e. pain, infertility, partnership, sexuality, depression, anxiety, stress, medical support, comorbidities and risk factors in the development of endometriosis: childhood trauma, life style factors, menstrual history
Time Frame: The questionnaire is answered once after at inclusion in the study, different questions cover different time periods ranging from childhood (0-17 years) to the actual situation (last 4 weeks/ 24hours) as specified in the questionnaire
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The outcome measures are assessed with internationally validated questionnaires i.e. modified version of the Brief Pain Inventory and Pain Disability Index, modified Form des Childhood Trauma Questionnaire, Brief Symptom Inventory, partnership questionnaire (PFB), modified version of the Brief Index of Sexual Functioning und Global sexual functioning, Hospital Anxiety and Depression Scale (HADS) as well as the questionnaire on life satisfaction (FLZ)
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The questionnaire is answered once after at inclusion in the study, different questions cover different time periods ranging from childhood (0-17 years) to the actual situation (last 4 weeks/ 24hours) as specified in the questionnaire
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalences of diseases such as dyspareunia, sexual disorders or adverse childhood experiences in the control group.
Time Frame: Once at inclusion in the study
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Measurements with internationally validated questionnaires and womens' medical history according to medical charts
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Once at inclusion in the study
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Comorbidity of chronic pain.
Time Frame: Once at inclusion in the study
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Measurements with internationally validated questionnaires and womens' medical history according to medical charts
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Once at inclusion in the study
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Brigitte Leeners, Prof. Dr., Clinic for Reproductive Endocrinology, University Hospital Zurich, Switzerland
Publications and helpful links
General Publications
- Sperschneider ML, Hengartner MP, Kohl-Schwartz A, Geraedts K, Rauchfuss M, Woelfler MM, Haeberlin F, von Orelli S, Eberhard M, Maurer F, Imthurn B, Imesch P, Leeners B. Does endometriosis affect professional life? A matched case-control study in Switzerland, Germany and Austria. BMJ Open. 2019 Jan 9;9(1):e019570. doi: 10.1136/bmjopen-2017-019570.
- Ramin-Wright A, Schwartz ASK, Geraedts K, Rauchfuss M, Wolfler MM, Haeberlin F, von Orelli S, Eberhard M, Imthurn B, Imesch P, Fink D, Leeners B. Fatigue - a symptom in endometriosis. Hum Reprod. 2018 Aug 1;33(8):1459-1465. doi: 10.1093/humrep/dey115.
- Liebermann C, Kohl Schwartz AS, Charpidou T, Geraedts K, Rauchfuss M, Wolfler M, von Orelli S, Haberlin F, Eberhard M, Imesch P, Imthurn B, Leeners B. Maltreatment during childhood: a risk factor for the development of endometriosis? Hum Reprod. 2018 Aug 1;33(8):1449-1458. doi: 10.1093/humrep/dey111.
- Kohl Schwartz AS, Wolfler MM, Mitter V, Rauchfuss M, Haeberlin F, Eberhard M, von Orelli S, Imthurn B, Imesch P, Fink D, Leeners B. Endometriosis, especially mild disease: a risk factor for miscarriages. Fertil Steril. 2017 Nov;108(5):806-814.e2. doi: 10.1016/j.fertnstert.2017.08.025.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Endo_QOL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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