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

NCT02319096 | Completed

• 1 other identifier: MedwayNHS
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Stress Incontinence

Keywords

Whole body vibration therapy; pelvic floor muscle training; stress urinary incontinence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• International Consultation on Incontinence Female lower Urinary Tract Symptoms Questionnaire

  12 weeks

• Pelvic Floor Distress Inventory - PFDI

  12 weeks

• Qualitative interview

  12 weeks

• Pelvic muscle contraction

  12 weeks

Study Arms (1)

Patients with stress incontinence

EXPERIMENTAL

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

Other: Whole body vibration therapy

Interventions

Whole body vibration therapy OTHER

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

Patients with stress incontinence

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stress predominant urinary incontinence
• Female patients \>18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Medway NHS Foundation Trust: lead

Study Sites (1)

Medway Maritime Hospital

Gillingham, Kent, Me7 5NY, United Kingdom

Location

Related 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):345-52. doi: 10.1001/jama.290.3.345.

  PMID: 12865375 RESULT

• Rovner ES, Wein AJ. Treatment options for stress urinary incontinence. Rev Urol. 2004;6 Suppl 3(Suppl 3):S29-47.

  PMID: 16985862 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.

  PMID: 22395850 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.

  PMID: 17392595 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.

  PMID: 23702666 RESULT

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jonathan RA Duckett, FRCOG

  Medway Maritime Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Obstetrician and Gynaecologist

Study Record Dates

• First Submitted: October 15, 2014
• First Posted: December 18, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 17, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)