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临床试验/NCT02319096
NCT02319096已完成不适用

Whole Body Vibration Plate Therapy and Pelvic Floor Muscle Strength in Females With Stress Urinary Incontinence

Medway NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2014年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
试验地点
2
主要终点
Patient Global Impression of Improvement scale (PGI-I)

研究概览

简要总结

Pelvic floor muscle training (PFMT) is the first line therapy recommended by NICE for the treatment of SUI. Due to poor motivation and compliance only 15-20% of women comply with the regimen. Whole body vibration (WBV) exercise has been developed as a new modality in the field of physiotherapy. The Galileo machine is a unique device for applying whole-body vibration. The investigators are currently using this therapy as an alternative to traditional pelvic floor muscle therapy. The investigators aim to audit the investigators treatment of whole body vibration.

详细描述

Pelvic floor muscle training (PFMT) is the first line therapy recommended by NICE for the treatment of SUI. It was first described by Arnold Kegel almost 60 years ago. PFMT exercises help the patient strengthen the muscles of the pelvic floor by the repeated high-intensity, rapid pelvic muscle contractions of both slow and fast twitch muscle fibres. The training of these muscles is difficult particularly when women have trouble in the perception of their PFM. This results in poor motivation and compliance with a Cochrane review suggesting that only 15-20% of women comply with the regimen.

Whole body vibration (WBV) exercise has been developed as a new modality in the field of physiotherapy. Whole body vibration (WBW) has a positive effect on muscle strength and rate of force. Stochastic WBV causes up to 12 muscle contractions per second which cannot be achieved by routine PFM exercise with supervision of a physiotherapist. The Galileo machine is a unique device for applying whole-body vibration. The investigators aim to audit their treatment of whole body vibration. This would be done using the patient global impression of improvement scale (PGI-I) and routine quality of life and symptoms questionnaires (International Consultation on Incontinence Female lower Urinary Tract Symptoms Questionnaire -ICIQ-FLUTS and Pelvic Floor Distress Inventory - PFDI) to be completed by the patient at initial appointment and 12 weeks after treatment and pelvic floor muscle assessment carried out at initial appointment and at 12 weeks. Patients will also have a qualitative interview with the Urogynaecology team to assess if therapy was found to be suitable and acceptable to patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

入选标准

  • Stress predominant urinary incontinence
  • Female patients >18 years

排除标准

  • Urgency predominant urinary incontinence
  • Symptomatic pelvic organ prolapse requiring intervention
  • Patients with bladder pathology (eg haematuria of unknown origin, UTI)
  • Contraindication to Whole Body Vibration
  • Musculoskeletal
  • Hip or knee endoprosthesis
  • Acute disc herniation
  • Joint fusion with metal implants
  • Acute arthritis
  • Osteoporosis with vertebral fracture
  • Recent Fracture
  • Acute Soft Tissue Injury
  • Acute Rheumatoid Arthritis
  • Cardiovascular
  • Recent myocardial infarction
  • Hypertension
  • Serious cardiovascular disease
  • Artificial heart valves
  • Pacemaker
  • Venous Thrombosis
  • Aortic Aneurysm
  • Peripheral vascular disease
  • Untreated orthostatic hypotension
  • Neuromuscular
  • Impaired sensation
  • Impaired cognition
  • Deep brain and spinal cord stimulators
  • Malignant tumours
  • Acute oedema
  • Impaired skin integrity of foot or leg
  • Recent surgery
  • Severe diabetes or migraines
  • Kidney and bladder stones
  • Pregnancy
  • Recently placed intrauterine devices or pins

结局指标

主要结局

Patient Global Impression of Improvement scale (PGI-I)

时间窗: 12 weeks

Patients will be asked answer the PGI-I questionnaire after a full 12 week course of therapy

次要结局

  • Qualitative interview(12 weeks)
  • Pelvic muscle contraction(12 weeks)
  • International Consultation on Incontinence Female lower Urinary Tract Symptoms Questionnaire(12 weeks)
  • Pelvic Floor Distress Inventory - PFDI(12 weeks)

研究者

发起方
Medway NHS Foundation Trust
申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Jonathan Duckett

Consultant Obstetrician and Gynaecologist

Medway NHS Foundation Trust

研究点 (2)

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