跳至主要内容
临床试验/NCT06961513
NCT06961513Enrolling By Invitation不适用

Patient-reported Outcomes and Views of Treatments for Pelvic-floor Muscle Dysfunction, and Their Relationship to Patient Psycho-social Characteristics.

Swansea University1 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2025年4月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
700
试验地点
1
主要终点
Attendance at sessions and improvement in pelvic-floor function.

研究概览

简要总结

Pelvic-floor muscle dysfunction (PFMD) affects 25% of women. It involves urinary and faecal incontinence, prolapse, sexual dysfunction, pelvic pain, and is associated with psycho-social issues (depression, anxiety), impacting negatively quality-of-life. First-line treatment for PFMD is women's health physiotherapy, which is safe, patient acceptable, and clinically effective. However, its effectiveness can be compromised by patient nonattendance/nonengagement, which can result in worsening of condition necessitating later surgery. The current research assesses factors contributing to outcomes, and nonattendance/nonengagement, so this knowledge may help improve healthcare system support and delivery. A range of routinely-collected factors at intake (physical functioning, psychological functioning, and demographic-social characteristics) will be related to routinely-gathered outcomes (patient-rated improvement in function; attendance and engagement). Additionally, a subset of patients who either attended or did not attend appointments, will be interviewed about their reasons for attendance/nonattendance. The aims are to determine: (1) whether any patient factors predict outcomes (functioning, attendance/engagement); (2) whether clusters of intake-factors differentiate patients who did/did not attended; and (3) patient views on why they attended or did not. Consecutively referred women with PFMD at the Women's Health Unit, Singleton Hospital, Swansea, will be asked for informed consent to participate. Following consent, routine assessment height, weight, age, diagnosis any physical measures of pelvic floor functioning will be taken, collected by medical staff. Questionnaires on patient-reported measures of pelvic-function, general health, quality of life, and psychological state will be completed, which should take 30min to complete. Patients will then have physiotherapy treatment, as usual. At discharge, the same data will be obtained. A subset of patients (N=80) will be contacted following initial appointment; half who attended, and half who did not. Following their consent to a telephone interview concerning their thoughts on the healthcare offered, and reasons they did/did not attend. This interview will be conducted, recorded anonymously, and analysed.

详细描述

Approximately 700 women with pelvic-floor muscle dysfunction (PFMD), consecutively referred to the Women's Health Unit at Singleton Hospital, Swansea, will be given full information about the study at their initial referral at Singleton Hospital, and asked if they would consent to participate. Following consent, routine assessment height, weight, age, diagnosis any physical measures of pelvic floor functioning will be taken, collected by medical staff The participants will ask completed questionnaires around patient-reported measures of their pelvic-function (Queensland), general health (SF-12) quality of life (EQ-5D), and psychological state (HADS; PVQ-II; ACEs; LSI; WPAQ) questionnaires. The should take about 30 minutes to complete. Patients will then have their Women's Health Physiotherapy treatment, as usual, which will not be impacted this research. At discharge, the same data as described above will be obtained. A randomly selected subset of patients (N=80) will be contacted following their initial appointment. Half of these will have attended, and half will not have attended their interview. Following them giving their informed consent to a telephone interview, they will participate in a semi-structured interview concerning their thoughts on the healthcare offered, and reasons they did/did not attend. This interview will last 15-30 minutes, depending on the participant, be conducted by a researcher who is not a member of their healthcare team, recorded anonymously, and analysed.

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
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Over 18 years old
  • Diagnosed with pelvic floor muscle dysfunction
  • Patients referred for physiotherapy treatment at the Women's Health Unit of Singleton Hospital, Swansea

排除标准

  • Patients under 18
  • Patients who don't have PFMD
  • Patients unable to give informed consent

研究组 & 干预措施

Women with pelvic-floor muscle dysfunction

Women with pelvic-floor muscle dysfunction undergoing women's health physiotherapy

干预措施: Women's health physiotherapy (Other)

结局指标

主要结局

Attendance at sessions and improvement in pelvic-floor function.

时间窗: 5 years

Attendance at scheduled sessions will be recorded, as will change in routinely collected pelvic floor functioning data.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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