Exploring Pelvic Floor Signs and Symptoms in Community Dwelling Women and Men: a Mixed-method Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,691
- 试验地点
- 1
- 主要终点
- sex- and gender differences in the incidence of (clusters of) pelvic floor symptoms
研究概览
简要总结
Rationale: Pelvic floor symptoms (PFS) are prevalent and often impair quality of life. They include micturition problems, defecation problems, pelvic organ prolapse, sexual problems and genito-pelvic pain. The pelvic floor is an anatomical and functional unit, and therefore different PFS may co-occur. However, literature on prevalence of clusters of PFS is scarce. Furthermore, PFS is understudied in the male population and when studies are performed in male subjects, studies do not assess the complete scope of possible PFS.
Objective: To generate a cohort, which provides information on sex- and gender differences in: prevalence and incidence of (clinically relevant clusters of) PFS, risk factors and prognostic factors for PFS, factors that reveal the impact of PFS on daily life, help seeking behavior and use of health care.
Study design: Prospective observational population-based cohort study with follow-up moments after 1 year and 2 years. Data of the questionnaire will be connected to medical record data from the participating general practitioners (GPs). A representative sample of female and male subjects with and without PFS will be invited for a physical examination to assess pelvic floor disorders and muscle function. Furthermore, a subsample of patients will be invited for a qualitative study consisting of semi-structured interviews on healthcare seeking behavior, including barriers and facilitators, preferences and satisfaction.
Study population: female and male subjects, aged ≥16 years of age, from the general population will be included. Exclusion criteria are: terminal disease, or dementia, cognitive impairment or current psychological condition precluding informed consent, not suitable or too ill to participate based on the judgement of the GP.
Main study parameters: To evaluate the sex- and gender difference in prevalence and incidence of (clinically relevant clusters of) PFS, the following primary parameters are assessed: lower urinary tract symptoms, bowel symptoms, urogenital prolapse (females only), sexual functioning, and pain. Secondary study parameters are factors associated with the development of PFS ('risk factors'), factors that predict the course of PFS ('prognostic factors'), factors that reveal the impact of PFS on daily life, help seeking behavior, and health care use (consultations for PFS and consultation frequency, diagnostic tests, diagnoses, treatment, and referrals).
详细描述
Primary Objective:
To explore sex- and gender differences in:
- the prevalence of (clinically relevant clusters) of PFS
- the incidence of (clinically relevant clusters) of PFS
Secondary Objectives:
To explore sex- and gender differences in: 3. factors associated with the development of PFS ('risk factors') 4. factors that predict the course of PFS ('prognostic factors') 5. factors that reveal the impact of PFS on daily life 6. help seeking behavior 7. health care use (consultations for PFS and consultation frequency, diagnostic tests, diagnoses, treatment, and referrals) among those who sought care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects are eligible to participate in the observational prospective cohort study, when they are 16 years or older and don't meet any exclusion criteria.
排除标准
- •The general practices will perform the selection of potential participants.
- •A potential subject who meets any of the following criteria will not be invited for the prospective cohort study:
- •terminal illnesses;
- •cognitive impairment (e.g. due to dementia) precluding informed consent;
- •current psychological condition precluding informed consent;
- •not suitable or too ill to participate based on the judgement of the GP.
结局指标
主要结局
sex- and gender differences in the incidence of (clusters of) pelvic floor symptoms
时间窗: after 2 years
sex- and gender differences in the incidence of (clusters of) pelvic floor symptoms
sex- and gender differences in the prevalence of (clusters of) pelvic floor symptoms
时间窗: prevalence after 2 years
To evaluate the sex-and gender difference in prevalence of (clinically relevant clusters of) PFS, the following primary parameters are assessed: lower urinary tract symptoms, bowel symptoms, prolapse, sexual functioning, and pain.
次要结局
- impact of PFS on daily functioning(at baseline, after 1 year, after 2 years)
- prognostic factors(at baseline, after 1 year, after 2 years)
- risk factors(at baseline, after 1 year, after 2 years)
- help seeking behavior(at baseline, after 1 year, after 2 years)
- health care use(at baseline, after 1 year, after 2 years)
研究者
Grietje E Knol-de Vries, PhD
coordinating investigator Postdoc researcher
University Medical Center Groningen
