Pelvic Pain and Pelvic Floor Muscle Function in Women With Endometriosis: Preliminary Findings From a Pilot Feasibility Case-Control Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Vaginal manometry (Myomed)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Vaginal manometry (Myomed)
时间窗: 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
次要结局
- pain levels(at baseline/at enrollment)
- physical activity(at baseline/enrollment)
- Pelvic floor function(at baseline/enrollment)
- Health-related quality of life(at baseline/enrollment)
- Effect of pelvic pain on the participants' everyday life(at baseline/enrollment)