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

Not Applicable

Completed

• Conditions: Urinary Stress Incontinence
• Interventions: Other: Whole body vibration therapy

• Registration Number: NCT02319096
• Lead Sponsor: Medway NHS Foundation Trust

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2014-10-15
• Study Start: 2014-12
• Study First Submitted QC: 2014-12-17
• Study First Posted: 2014-12-18
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-13
• Last Update Posted: 2016-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

1. Stress predominant urinary incontinence
2. Female patients >18 years

Exclusion Criteria

1. Urgency predominant urinary incontinence

2. Symptomatic pelvic organ prolapse requiring intervention

3. Patients with bladder pathology (eg haematuria of unknown origin, UTI)

4. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with stress incontinence	Whole body vibration therapy	Patients who present to urogynaecology clinic with proven stress urinary incontinence who will be offered Whole body vibration therapy.

Primary Outcome Measures

Name	Time	Method
Patient Global Impression of Improvement scale (PGI-I)	12 weeks	Patients will be asked answer the PGI-I questionnaire after a full 12 week course of therapy

Secondary Outcome Measures

Name	Time	Method
Qualitative interview	12 weeks	A qualitative interview will be conducted with the urogynaecology team to assess if patients found the new therapy suitable and acceptable.
Pelvic muscle contraction	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
International Consultation on Incontinence Female lower Urinary Tract Symptoms Questionnaire	12 weeks	Patients will be asked to answer the ICIQ-FLUTS to assess symptom improvement after a full 12 week course of therapy
Pelvic Floor Distress Inventory - PFDI	12 weeks	Patients will be asked to answer the PFDI-I to assess any improvement in quality of life after a full 12 weeks

Trial Locations

Locations (1)

Medway Maritime Hospital; 🇬🇧 Gillingham, Kent, United Kingdom