Physiotherapy Management of Urinary Incontinence in Athletic Women- A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Recruitment rate
研究概览
简要总结
Nearly half of all adult women suffer with Urinary incontinence (UI), this is more common in athletes.
UI is considered to be due to weak pelvic floor muscles. Standard advice encourages strength and endurance training; however, assessment of pelvic floor muscles can sometimes reveal overactive or tight tissues.
Evidence suggests athletes have stronger pelvic floors than non-athletes. If the pelvic floor is overactive, general advice regarding pelvic floor strengthening will not improve UI, and may make it worse.
This study will explore the feasibility of conducting a larger trial to identify cost effectiveness and benefits of treating athletes with physiotherapy and how this might differ from current practice.
15 -20 athletic women will complete questionnaires regarding their UI and its effects on them. They will receive physiotherapy; the assessment will include a history and internal examination of their pelvic floor. This will inform a tailored rehabilitation program.
Interviews will be conducted with some of these women to explore their response to the intervention. Interviews with health professionals will establish current practice for this patient group.
The results will tell us how likely it is for athletes to volunteer and take part in a future study and which outcomes are useful.
详细描述
Aims: The investigator's overall purpose is to conduct an RCT to determine whether one to one physiotherapy can improve the symptoms of urinary incontinence (UI) in a group of athletic women. This feasibility study will enable us to ascertain the viability of conducting a definitive appropriately powered trial.
Research protocol: The research design is a mixed methods study with three distinct but related phases.
Phase 1: 6-8 local health care professionals (GPs, nurses and physiotherapists) will be recruited for interview to explore current management practices of urinary incontinence (UI) in primary care.
Phase 2: 15-20 sporting or athletic women who self- report symptoms of UI will be recruited from the local sporting community. Each will undergo individual subjective and objective assessments in order to establish history, symptoms and pelvic floor muscle function. The intervention will be then be tailored from these assessments and agreed between each individual and the specialist physiotherapist. It will include guided exercise within the clinic and a regular home exercise plan, in keeping with typical pelvic health regimes for pelvic floor muscle (PFM) dysfunction.
Phase 3: 6-8 participants from phase 2 will be invited to take part in a qualitative interview in order to gain more in-depth understanding of UI. Purposeful selection will account for age, sporting activity and severity of symptoms. The interviews will be to explore the effects of UI on their quality of life, their participation in sport and exercise and the acceptability of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Phase 1: Qualified local Health Care Professional eg G.P., nurse or chartered physiotherapist working within Nottinghamshire or Derbyshire
- •Phases 2 and 3:Adult female Currently exercising for a minimum 3 times a week and for over 150 minutes per week Self-reported experience of symptoms of UI defined as; leaking of urine associated with increased abdominal pressure e.g. impact, leaking of urine associated with urinary urge, increased urinary urge and/or increased urinary frequency
排除标准
- •Phase 1: Unwilling or unable to provide written informed consent Not within Nottinghamshire or Derbyshire area
- •Phases 2 and 3: Under 18 Sports participation less than 1 year Pregnancy Less than one year after childbirth Ongoing physiotherapy or continence advice treatment elsewhere or within the last year De novo oestrogen or anticholinergic treatment Existing neurological conditions that may contribute to UI eg multiple sclerosis, stroke, spinal injury etc Unwilling or unable to provide written informed consent Unable to read or speak English
结局指标
主要结局
Recruitment rate
时间窗: Up to 8 Months
Ease of recruiting participants directly from gyms and sports clubs
Acceptability of the secondary outcome measures used in Phase 2: % positive feedback for each outcome measure from the interviews
时间窗: Up to 9 months
Measured as the % positive feedback for each outcome measure from the interviews in Phase 3
Attrition rate
时间窗: 6 months after the participant's first assessment
The number of participants who consent to participate that remain in the study
Acceptability of the intervention: % that give positive feedback from the interviews
时间窗: Up to 9 months
Measured as the % that give positive feedback from the interviews in Phase 3
Timescale required for intervention
时间窗: Six months for each participant from the first assessment
The time required for a successful intervention. This will be measured by the change in the secondary outcome measures between the three month assessment and the six months assessment
次要结局
- Urinary Distress Inventory (UDI) 6(Six months from the first assessment for each participant)
- International Consultation on Incontinence Modular Questionnaire Female Lower Urinary Tract Symptoms Long Form Module (ICIQ-FLUTS-LF)(Six months from the first assessment for each participant)