EndometriosisNCT07713108
Pelvic Floor Muscle Function and Endometriosis-Related Pelvic Pain
An observational study of Endometriosis and Chronic Pelvic Pain, run by University of Pecs at 1 site in Hungary.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis, Chronic Pelvic Pain, Pelvic Pain Associated With Endometriosis or Adenomyosis
- How many people
- 100 participants
- Where
- 1 siteHungary
- Study dates
- 1 Apr 2026to 1 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 48 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women medically diagnosed with endometriosis or healthy women age between 18-48.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hungary1 site, 1 recruiting
- Recruiting
University of Pécs Faculty of Health Sciences
Pécs, Baranya, 7621
Zsófia Kovács-Szabó, MSc, +36204317662, zsofia.szabo@etk.pte.hu
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Endometriosis, Chronic Pelvic Pain, Pelvic Pain Associated With Endometriosis or Adenomyosis
- Keywords
- Endometriosis, pelvic pain, pelvic floor muscle, manometry
- Medical subject headings
- Endometriosis, Adenomyosis, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at baseline/enrollment
Secondary outcomes (5)
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.
Measured: at baseline/at enrollment
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.
Measured: at baseline/enrollment
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.
Measured: at baseline/enrollment
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.
Measured: at baseline/enrollment
Effect of pelvic pain on the participants' everyday life
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.
Measured: at baseline/enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start1 Apr 2026
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07713108
- Sponsor's protocol ID
- PTE-ENDO-2026-01
- Status last verified
- May 2026
- First submitted
- 1 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Pain and Pelvic Floor Muscle Function in Women With Endometriosis: Preliminary Findings From a Pilot Feasibility Case-Control Study
- ClinicalTrials.gov ID
- NCT07713108
- Acronym / sponsor ID
- PTE-ENDO-2026-01
- Conditions
- Endometriosis, Chronic Pelvic Pain, Pelvic Pain Associated With Endometriosis or Adenomyosis
- Keywords
- Endometriosis, pelvic pain, pelvic floor muscle, manometry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women medically diagnosed with endometriosis or healthy women age between 18-48.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Vaginal manometry (Myomed)
Time frame: 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
5 secondary outcomes
pain levels
Time frame: at baseline/at enrollment
physical activity
Time frame: at baseline/enrollment
Pelvic floor function
Time frame: at baseline/enrollment
Health-related quality of life
Time frame: at baseline/enrollment
Effect of pelvic pain on the participants' everyday life
Time frame: at baseline/enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis and Chronic Pelvic Pain, run by University of Pecs at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kovács-Szabó Zsófia, MSc (+36204317662, zsofia.szabo@etk.pte.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal manometry (Myomed) (time frame: at baseline/enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.