Klinisk forsøg med Endometriose, Kroniske bækkensmerter, Bækkenbesvær forbundet med endometriose eller adenomyose - Kliniske forsøgsregister

Studieoversigt

Status

Rekruttering

Betingelser

Detaljeret beskrivelse

Study design: Cross-sectional study. Target population: Women of reproductive age (18-50 years) with endometriosis, as well as healthy controls.

Sampling method: Convenience sampling; participants will be recruited via online platforms and in medical outpatient clinics.

Inclusion criteria: Women aged 18-50 years in reproductive age will be included. The study group will consist of women with self-reported endometriosis, while the control group will include women who are gynecologically healthy and report no history of endometriosis. Additional inclusion criteria are adequate knowledge of the Hungarian language, access to the internet, and provision of informed consent.

Exclusion criteria: Lack of capacity to provide informed consent, severe physical or cognitive impairment, pregnancy, postpartum period, and diagnosed malignant disease.

Expected sample size: 100-140 participants. Study methodology and procedures Participants will be recruited using convenience sampling. The study consists of two parts.

The questionnaire package includes general questions (sociodemographic and anthropometric data, physical activity and exercise habits, assessment of the presence and intensity of pelvic pain, and obstetric-gynecological history), as well as several validated self-administered questionnaires.

Body mass index (BMI) will be calculated based on self-reported height and weight. Pain intensity will be assessed using the Visual Analogue Scale (VAS).

The following validated instruments are included:

VAS (Visual Analogue Scale) (Freyd, 1923) A unidimensional, 11-point scale widely used to assess subjective pain intensity ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will rate their average and worst pain over the past four weeks, as well as their current pain at the time of questionnaire completion.

GPAQ (Global Physical Activity Questionnaire) (Armstrong & Bull, 2006; Ács et al., 2020) A 16-item questionnaire developed by the WHO to assess physical activity across work, transportation, and recreational domains, including sedentary behavior. Activity levels are expressed in minutes per week. Participants will be classified as physically active if they engage in at least 150 minutes of recreational physical activity per week, based on WHO recommendations (WHO, 2023).

SF-36 (Short Form Health Survey) (Ware & Sherbourne, 1992) A self-administered questionnaire measuring health-related quality of life across eight domains, including physical functioning, bodily pain, role limitations (physical and emotional), social functioning, mental health, and general health. Scores range from 0 to 100, with higher scores indicating better quality of life.

EHP-30 (Endometriosis Health Profile) (Jones et al., 2001) A disease-specific, validated questionnaire assessing the impact of endometriosis on quality of life across five domains: pain, control and powerlessness, emotional well-being, social support, and self-image. Scores range from 0 to 100, with higher scores indicating worse quality of life.

PPIQ (Pelvic Pain Impact Questionnaire) (Chalmers et al., 2017; Kovács-Szabó et al., 2025) A culturally adapted and validated Hungarian instrument assessing the impact of pelvic pain on daily life over the past month. It includes 10 items rated on a 0-4 Likert scale, with higher scores indicating greater impact.

APFQ (Australian Pelvic Floor Questionnaire) (Baessler et al., 2009; Hock et al., 2023) A 38-item questionnaire assessing bladder, bowel, prolapse, and sexual function, along with symptom-related distress. Domain scores range from 0 to 10, with a total maximum score of 40 indicating severe pelvic floor dysfunction.

Instrumental measurements Objective assessment of pelvic floor muscle function will be performed using the Myomed 932 surface EMG device.

The aim of the measurement is to determine pelvic floor muscle endurance, maximal voluntary contraction, and relaxation ability using surface electromyography and a vaginal manometric probe.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

100

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Navn: Kovács-Szabó Zsófia, MSc
Telefonnummer: +36204317662
E-mail: zsofia.szabo@etk.pte.hu

Studiesteder

Ungarn
- Baranya
  - Pécs, Baranya, Ungarn, 7621
    - Rekruttering
    - University of Pécs Faculty of Health Sciences
    - Kontakt:
      
      Zsófia Kovács-Szabó, MSc
      
      Telefonnummer: +36204317662
      
      E-mail: zsofia.szabo@etk.pte.hu

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Voksen

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Women medically diagnosed with endometriosis or healthy women age between 18-48.

Beskrivelse

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal grupper/kohorter

2

Kohorter og interventioner

Gruppe / kohorte
Women between 18-48 medically diagnosed with endometriosis Women who are diagnosed with endometriosis
Women between 18-48 not diagnosed with any gynecological disorder, healthy Women who are not diagnosed with any gynecological disease

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Vaginal manometry (Myomed) Tidsramme: at baseline/enrollment	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	at baseline/enrollment

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
pain levels Tidsramme: at baseline/at enrollment	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.	at baseline/at enrollment
physical activity Tidsramme: at baseline/enrollment	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.	at baseline/enrollment
Pelvic floor function Tidsramme: at baseline/enrollment	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.	at baseline/enrollment
Health-related quality of life Tidsramme: at baseline/enrollment	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.	at baseline/enrollment
Effect of pelvic pain on the participants' everyday life Tidsramme: at baseline/enrollment	The effect of pelvic pain on the women's everyday life was measured by the Pelvic Pain Impact Questionnaire. The Pelvic Pain Impact Questionnaire (PPIQ) is a self-administered instrument designed to assess the impact of pelvic pain on daily function. It consists of eight mandatory and two optional items, each rated on a 5-point Likert scale. The total score ranges from 0 to 32 (0-40 if including the two optional items), with higher scores indicating a greater negative impact of pelvic pain on daily activities.	at baseline/enrollment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Pecs

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. april 2026

Primær færdiggørelse (Anslået)

1. oktober 2026

Studieafslutning (Anslået)

1. september 2028

Datoer for studieregistrering

Først indsendt

1. juli 2026

Først indsendt, der opfyldte QC-kriterier

14. juli 2026

Først opslået (Faktiske)

20. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)