Urinary Stress IncontinenceNCT02319096
Vibration Training and Pelvic Floor Muscle Strength in Females With Stress Urinary Incontinence
A study testing Whole body vibration therapy in people with Urinary Stress Incontinence, run by Medway NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Stress Incontinence
- What is being tested?
- Whole body vibration therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stress predominant urinary incontinence
- Female patients >18 years
Who cannot join
- 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
Show all 37Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Medway Maritime Hospital
Gillingham, Kent, Me7 5NY
About this study
Official title: Whole Body Vibration Plate Therapy 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.
Read the 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.
- Conditions
- Urinary Stress Incontinence
- Being tested
- Whole body vibration therapy
- Keywords
- Whole body vibration therapy, pelvic floor muscle training, stress urinary incontinence
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole body vibration therapyOther
Whole body vibration therapy using the Galileo machine as therapy for pelvic floor muscle training
| Study group | Role | What they receive |
|---|---|---|
| Patients with stress incontinence | Experimental | Patients who present to urogynaecology clinic with proven stress urinary incontinence who will be offered Whole body vibration therapy. Receives: Other: Whole body vibration therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (4)
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
Measured: 12 weeks
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
Measured: 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.
Measured: 12 weeks
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Urinary Stress IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medway NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Jonathan Duckett, Medway NHS Foundation Trust
- Investigators
- Jonathan RA Duckett, FRCOG, Principal investigator, Medway Maritime Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02319096
- Sponsor's protocol ID
- MedwayNHS
- Status last verified
- Oct 2016
- First submitted
- 15 Oct 2014
- Last updated
- 17 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 12865375Rovner ES, Wein AJ. Treatment options for stress urinary incontinence. Rev Urol. 2004;6 Suppl 3(Suppl 3):S29-47.
PubMed 16985862Luginbuehl 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.
PubMed 22395850Kawanabe 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.
PubMed 17392595Vella 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.
PubMed 23702666
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Body Vibration Plate Therapy and Pelvic Floor Muscle Strength in Females With Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT02319096
- Acronym / sponsor ID
- MedwayNHS
- Conditions
- Urinary Stress Incontinence
- Keywords
- Whole body vibration therapy, pelvic floor muscle training, stress urinary incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Medway NHS Foundation TrustUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 18 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with stress incontinence | Experimental | Other: Whole body vibration therapyPatients who present to urogynaecology clinic with proven stress urinary incontinence who will be offered Whole body vibration therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Stress predominant urinary incontinence
- Female patients >18 years
Key exclusion criteria (37 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole body vibration therapyWhole body vibration therapy using the Galileo machine as therapy for pelvic floor muscle training | Other | Patients with stress incontinence |
Primary outcome
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
4 secondary outcomes
International Consultation on Incontinence Female lower Urinary Tract Symptoms Questionnaire
Time frame: 12 weeks
Pelvic Floor Distress Inventory - PFDI
Time frame: 12 weeks
Qualitative interview
Time frame: 12 weeks
Pelvic muscle contraction
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2016.
- Results publication: PubMed 12865375Goode 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 publication: PubMed 16985862Rovner ES, Wein AJ. Treatment options for stress urinary incontinence. Rev Urol. 2004;6 Suppl 3(Suppl 3):S29-47.
- Results publication: PubMed 22395850Luginbuehl 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 publication: PubMed 17392595Kawanabe 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 publication: PubMed 23702666Vella 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan RA Duckett, FRCOG principal investigator
Medway Maritime Hospital NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole body vibration therapy in people with Urinary Stress Incontinence, run by Medway NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Global Impression of Improvement scale (PGI-I) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02319096, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2016.