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

Urinary Stress Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02319096
• Other study ID #: MedwayNHS
• Status: Completed
• Phase: N/A
• First received: October 15, 2014
• Last updated: October 13, 2016
• Start date: December 2014
• Est. completion date: December 2015

Study information

• Verified date: October 2016
• Source: Medway NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence
• Urinary Incontinence, Stress
• Urinary Stress Incontinence

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Medway Maritime Hospital	Gillingham	Kent

Sponsors (1)

Lead Sponsor	Collaborator
Medway NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (5)

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) — View 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. — View 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/n — View Citation

Rovner ES, Wein AJ. Treatment options for stress urinary incontinence. Rev Urol. 2004;6 Suppl 3:S29-47. — View 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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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	12 weeks
Secondary	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
Secondary	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