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Pelvic Floor Muscle Function and Endometriosis-Related Pelvic Pain

14 lipca 2026 zaktualizowane przez: University of Pecs

Pelvic Pain and Pelvic Floor Muscle Function in Women With Endometriosis: Preliminary Findings From a Pilot Feasibility Case-Control Study

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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

100

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Węgry
    • Baranya
      • Pécs, Baranya, Węgry, 7621
        • Rekrutacyjny
        • University of Pécs Faculty of Health Sciences
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Tak

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
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

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Vaginal manometry (Myomed)
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
pain levels
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Pecs

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 kwietnia 2026

Zakończenie podstawowe (Szacowany)

1 października 2026

Ukończenie studiów (Szacowany)

1 września 2028

Daty rejestracji na studia

Pierwszy przesłany

1 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

14 lipca 2026

Pierwszy wysłany (Rzeczywisty)

20 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

20 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

14 lipca 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • PTE-ENDO-2026-01

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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