Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02511626 |
| Other study ID # |
Endo_QOL |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 2010 |
| Est. completion date |
December 2019 |
Study information
| Verified date |
September 2022 |
| Source |
University of Zurich |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
