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Quality of Life in Endometriosis - a Case Control Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02511626
Recruitment Status : Active, not recruiting
First Posted : July 30, 2015
Last Update Posted : January 30, 2019
Sponsor:
Collaborators:
Triemli Hospital
Cantonal Hospital of St. Gallen
Kantonsspital Baden
Kantonsspital Winterthur KSW
Kantonsspital Schaffhausen
Charite University, Berlin, Germany
University Hospital, Aachen
Vivantes Kliniken Berlin
Medical University of Graz
Information provided by (Responsible Party):
University of Zurich

Tracking Information
First Submitted Date July 20, 2015
First Posted Date July 30, 2015
Last Update Posted Date January 30, 2019
Study Start Date January 2010
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 9, 2017)
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 ]
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)
Original Primary Outcome Measures
 (submitted: July 27, 2015)
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: Once at inclusion in the study ]
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)
Change History Complete list of historical versions of study NCT02511626 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 10, 2015)
  • Prevalences of diseases such as dyspareunia, sexual disorders or adverse childhood experiences in the control group. [ Time Frame: Once at inclusion in the study ]
    Measurements with internationally validated questionnaires and womens' medical history according to medical charts
  • Comorbidity of chronic pain. [ Time Frame: Once at inclusion in the study ]
    Measurements with internationally validated questionnaires and womens' medical history according to medical charts
Original Secondary Outcome Measures
 (submitted: July 27, 2015)
  • Prevalences of diseases such as dyspareunia, sexual disorders or adverse childhood experiences in the control group. [ Time Frame: Once at inclusion in the study ]
  • Comorbidity of chronic pain. [ Time Frame: Once at inclusion in the study ]
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title Quality of Life in Endometriosis - a Case Control Study
Official Title Quality of Life in Endometriosis - a Case Control Study Using Internationally Validated Questionnaires
Brief Summary

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.

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 Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population

Female Age >18

Case group: women with endometriosis Healthy volunteers in control group

Condition
  • Endometriosis
  • Quality of Life
  • Pain
  • Sexuality
  • Anxiety
  • Depression
  • Infertility
Intervention Not Provided
Study Groups/Cohorts
  • Case group
    Women with a surgically confirmed diagnosis of endometriosis
  • Control group 1
    Women without any evidence of endometriosis (= no clinical symptom and/or no surgical evidence of endometriosis)
  • Control group 2
    Women without endometriosis (surgically confirmed) but chronic abdominal/pelvic pain due to other reasons (e.g. Crohn's disease, colitis etc)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: November 9, 2017)
1267
Original Estimated Enrollment
 (submitted: July 27, 2015)
1300
Estimated Study Completion Date December 2019
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT02511626
Other Study ID Numbers Endo_QOL
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of Zurich
Study Sponsor University of Zurich
Collaborators
  • Triemli Hospital
  • Cantonal Hospital of St. Gallen
  • Kantonsspital Baden
  • Kantonsspital Winterthur KSW
  • Kantonsspital Schaffhausen
  • Charite University, Berlin, Germany
  • University Hospital, Aachen
  • Vivantes Kliniken Berlin
  • Medical University of Graz
Investigators
Principal Investigator: Brigitte Leeners, Prof. Dr. Clinic for Reproductive Endocrinology, University Hospital Zurich, Switzerland
PRS Account University of Zurich
Verification Date January 2019