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

Sponsor

Medway NHS Foundation Trust (Other)

Overall Status

Completed

CT.gov ID

NCT02319096

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Stress Incontinence	Other: Whole body vibration therapy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2014

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients with stress incontinence Patients who present to urogynaecology clinic with proven stress urinary incontinence who will be offered Whole body vibration therapy.	Other: Whole body vibration therapy Whole body vibration therapy using the Galileo machine as therapy for pelvic floor muscle training

Arm

Intervention/Treatment

Experimental: Patients with stress incontinence

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

Other: Whole body vibration therapy

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

Outcome Measures

Primary Outcome Measures

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

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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medway Maritime Hospital	Gillingham	Kent	United Kingdom	Me7 5NY

Sponsors and Collaborators

Medway NHS Foundation Trust

Investigators

Principal Investigator: Jonathan RA Duckett, FRCOG, Medway Maritime Hospital NHS Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Professor Jonathan Duckett, Consultant Obstetrician and Gynaecologist, Medway NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT02319096

Other Study ID Numbers:

MedwayNHS

First Posted:

Dec 18, 2014

Last Update Posted:

Oct 17, 2016

Last Verified:

Oct 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Professor Jonathan Duckett, Consultant Obstetrician and Gynaecologist, Medway NHS Foundation Trust

Whole body vibration therapy

pelvic floor muscle training

stress urinary incontinence

Additional relevant MeSH terms:

Urinary Incontinence

Enuresis

Urinary Incontinence, Stress

Study Results

No Results Posted as of Oct 17, 2016