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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with stress incontinence | Experimental | Patients who present to urogynaecology clinic with proven stress urinary incontinence who will be offered Whole body vibration therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole body vibration therapy | Other | Whole body vibration therapy using the Galileo machine as therapy for pelvic floor muscle training |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 weeks |
| Pelvic Floor Distress Inventory - PFDI |
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Inclusion Criteria:
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
Cardiovascular
Neuromuscular
Other
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan RA Duckett, FRCOG | Medway Maritime Hospital NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medway Maritime Hospital | Gillingham | Kent | Me7 5NY | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12865375 | Result | 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. | |
| 16985862 | Result |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 30, 2017 | |
| Reset | Jun 14, 2017 | |
| Release | Sep 16, 2017 | |
| Reset | May 25, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 30, 2017 | Jun 14, 2017 | |||
| Sep 16, 2017 |
| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Patients will be asked to answer the PFDI-I to assess any improvement in quality of life after a full 12 weeks |
| 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. | 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 | 12 weeks |
| Rovner ES, Wein AJ. Treatment options for stress urinary incontinence. Rev Urol. 2004;6 Suppl 3(Suppl 3):S29-47. |
| 22395850 | Result | 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. |
| 17392595 | Result | 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. |
| 23702666 | Result | 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. |
| May 25, 2018 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |