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Completed

NCT Number: NCT02319096

Vibration Training and Pelvic Floor Muscle Strength in Females With Stress Urinary Incontinence

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Stress predominant urinary incontinence
  • Female patients >18 years

Exclusion criteria

  • 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
  • Hernia
  • Neuromuscular
  • Impaired sensation
  • Impaired cognition
  • Deep brain and spinal cord stimulators
  • Other
  • 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

Treatment and study plan

Whole body vibration therapy

Other

Whole body vibration therapy using the Galileo machine as therapy for pelvic floor muscle training

Primary outcomes

  1. Patient Global Impression of Improvement scale (PGI-I)

    Time frame: 12 weeks

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

Secondary outcomes

  1. International Consultation on Incontinence Female lower Urinary Tract Symptoms Questionnaire

    Time frame: 12 weeks

    Patients will be asked to answer the ICIQ-FLUTS to assess symptom improvement after a full 12 week course of therapy

  2. Pelvic Floor Distress Inventory - PFDI

    Time frame: 12 weeks

    Patients will be asked to answer the PFDI-I to assess any improvement in quality of life after a full 12 weeks

  3. Qualitative interview

    Time frame: 12 weeks

    A qualitative interview will be conducted with the urogynaecology team to assess if patients found the new therapy suitable and acceptable.

  4. Pelvic muscle contraction

    Time frame: 12 weeks

    Pelvic muscle contraction will be measured at Week 0 and Week 12 using a pelvic perineometer to assess any improvement in pelvic muscle strength

Sponsors and collaborators

Lead sponsor

Medway NHS Foundation Trust

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 18, 2014
Registry last updated
Oct 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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