About this trial
Our study aims to investigate the associations between endometriosis-related pelvic pain and pelvic floor muscle strength, endurance, and relaxation ability, as well as quality of life, physical activity, and the presence of pelvic floor symptoms. Furthermore, it aims to assess the function of muscles synergistic with the pelvic floor in comparison with healthy controls.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Women aged 18-50 years of reproductive age with self-reported endometriosis will be included in the study group, while women aged 18-50 years of reproductive age who are gynecologically healthy and report no history of endometriosis will be included in the control group. Additional inclusion criteria include adequate proficiency in the Hungarian language, access to the internet, and provision of informed consent.
Disqualifiers
Exclusion criteria include lack of capacity to provide informed consent, severe physical or cognitive impairment, pregnancy, postpartum period, diagnosed malignant disease, or the presence of vaginal infection or inflammation.
Trial population
Women medically diagnosed with endometriosis or healthy women age between 18-48.
Trial design
Case-control
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Vaginal manometry (Myomed)
Pelvic floor muscle function will be assessed using intravaginal pressure manometry with the Myomed 932 device (Enraf-Nonius B.V., Rotterdam, The Netherlands) and a conical vaginal probe. All assessments will be performed by the same trained pelvic floor physiotherapist following a standardized protocol. Participants will be instructed to empty their bladder before the assessment and will be evaluated in the supine position. After correct probe placement and baseline calibration, participants will perform three maximal voluntary contractions (MVCs), and the highest pressure value (hPa) will be used to determine maximal pelvic floor muscle strength. Muscle endurance will be assessed by maintaining a contraction at approximately 80% of maximal effort, while dynamic muscle function will be evaluated by recording the number of rapid contractions performed within 30 seconds. Only correctly performed pelvic floor muscle contractions without compensatory activation of the abdominal, hip addu
Secondary outcomes
pain levels
With Numeric Rating Scale 0-10 pelvic pain levels are measured. It utilizes an 11-point scale ranging from 0 to 10, where 0 represents no pain and 10 indicates the worst pain. Participants were asked to rate their average and maximum pain levels over the previous four weeks and their current pain intensity at the time of assessment.
physical activity
Physical activity levels were assessed with the Global Physical Activity Questionnaire. Physical activity will be assessed using the Global Physical Activity Questionnaire (GPAQ), a validated instrument developed by the World Health Organization. The GPAQ consists of 16 items assessing physical activity in three domains (work, transport, and leisure-time) as well as sedentary behavior. Responses will be used to calculate total physical activity expressed in metabolic equivalent (MET)-minutes per week according to the WHO GPAQ analysis guidelines.
Pelvic floor function
Measuring pelvic floor function including sexual, bowel, urinary tract function via Australian Pelvic Floor Questionnaire. Hungarian version. The Australian Pelvic Floor Questionnaire (APFQ) is a validated instrument used to assess pelvic floor dysfunction in four domains: bladder function, bowel function, prolapse symptoms, and sexual function. The questionnaire consisted of 38 items, along with additional items evaluating the subjective burden of symptoms. Items are primarily rated on a 4-point scale, and domain scores are calculated as a proportion of the maximum possible score and multiplied by ten, resulting in values ranging from 0 to 10. The total score ranges from 0 to 40, with higher scores indicating more severe pelvic floor dysfunctions.
Health-related quality of life
Health related quality of life is measured by the Endometriosis Health Profile. Endometriosis Health Profile-30 (EHP-30): The EHP-30 is a validated, disease-specific patient-reported outcome questionnaire designed to assess health-related quality of life in women with endometriosis. The core instrument consists of 30 items across five domains: pain, control and powerlessness, emotional well-being, social support, and self-image. Higher scores indicate greater impairment in quality of life. The EHP-30 is widely used in clinical research to evaluate disease burden and treatment outcomes in patients with endometriosis.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.