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

Primary Purpose

Urinary Stress Incontinence

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Whole body vibration therapy
Sponsored by
Medway NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Stress Incontinence focused on measuring Whole body vibration therapy, pelvic floor muscle training, stress urinary incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Medway Maritime Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with stress incontinence

Arm Description

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

Outcomes

Primary Outcome Measures

Patient Global Impression of Improvement scale (PGI-I)
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
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
Patients will be asked to answer the PFDI-I to assess any improvement in quality of life after a full 12 weeks
Qualitative interview
A qualitative interview will be conducted with the urogynaecology team to assess if patients found the new therapy suitable and acceptable.
Pelvic muscle contraction
Pelvic muscle contraction will be measured at Week 0 and Week 12 using a pelvic perineometer to assess any improvement in pelvic muscle strength

Full Information

First Posted
October 15, 2014
Last Updated
October 13, 2016
Sponsor
Medway NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02319096
Brief Title
Vibration Training and Pelvic Floor Muscle Strength in Females With Stress Urinary Incontinence
Official Title
Whole Body Vibration Plate Therapy and Pelvic Floor Muscle Strength in Females With Stress Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medway NHS Foundation Trust

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Stress Incontinence
Keywords
Whole body vibration therapy, pelvic floor muscle training, stress urinary incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with stress incontinence
Arm Type
Experimental
Arm Description
Patients who present to urogynaecology clinic with proven stress urinary incontinence who will be offered Whole body vibration therapy.
Intervention Type
Other
Intervention Name(s)
Whole body vibration therapy
Intervention Description
Whole body vibration therapy using the Galileo machine as therapy for pelvic floor muscle training
Primary Outcome Measure Information:
Title
Patient Global Impression of Improvement scale (PGI-I)
Description
Patients will be asked answer the PGI-I questionnaire after a full 12 week course of therapy
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
International Consultation on Incontinence Female lower Urinary Tract Symptoms Questionnaire
Description
Patients will be asked to answer the ICIQ-FLUTS to assess symptom improvement after a full 12 week course of therapy
Time Frame
12 weeks
Title
Pelvic Floor Distress Inventory - PFDI
Description
Patients will be asked to answer the PFDI-I to assess any improvement in quality of life after a full 12 weeks
Time Frame
12 weeks
Title
Qualitative interview
Description
A qualitative interview will be conducted with the urogynaecology team to assess if patients found the new therapy suitable and acceptable.
Time Frame
12 weeks
Title
Pelvic muscle contraction
Description
Pelvic muscle contraction will be measured at Week 0 and Week 12 using a pelvic perineometer to assess any improvement in pelvic muscle strength
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan RA Duckett, FRCOG
Organizational Affiliation
Medway Maritime Hospital NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medway Maritime Hospital
City
Gillingham
State/Province
Kent
ZIP/Postal Code
Me7 5NY
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12865375
Citation
Goode PS, Burgio KL, Locher JL, Roth DL, Umlauf MG, Richter HE, Varner RE, Lloyd LK. Effect of behavioral training with or without pelvic floor electrical stimulation on stress incontinence in women: a randomized controlled trial. JAMA. 2003 Jul 16;290(3):345-52. doi: 10.1001/jama.290.3.345.
Results Reference
result
PubMed Identifier
16985862
Citation
Rovner ES, Wein AJ. Treatment options for stress urinary incontinence. Rev Urol. 2004;6 Suppl 3(Suppl 3):S29-47.
Results Reference
result
PubMed Identifier
22395850
Citation
Luginbuehl H, Lehmann C, Gerber R, Kuhn A, Hilfiker R, Baeyens JP, Radlinger L. Continuous versus intermittent stochastic resonance whole body vibration and its effect on pelvic floor muscle activity. Neurourol Urodyn. 2012 Jun;31(5):683-7. doi: 10.1002/nau.21251. Epub 2012 Mar 6.
Results Reference
result
PubMed Identifier
17392595
Citation
Kawanabe K, Kawashima A, Sashimoto I, Takeda T, Sato Y, Iwamoto J. Effect of whole-body vibration exercise and muscle strengthening, balance, and walking exercises on walking ability in the elderly. Keio J Med. 2007 Mar;56(1):28-33. doi: 10.2302/kjm.56.28.
Results Reference
result
PubMed Identifier
23702666
Citation
Vella M, Nellist E, Cardozo L, Mastoroudes H, Giarenis I, Duckett J. Does self-motivation improve success rates of pelvic floor muscle training in women with urinary incontinence in a secondary care setting? Int Urogynecol J. 2013 Nov;24(11):1947-51. doi: 10.1007/s00192-013-2115-x. Epub 2013 May 24.
Results Reference
result

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

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