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Modified Pilates as an adjunct treatment for urinary incontinence
ISRCTN ISRCTN74075972
DOI 10.1186/ISRCTN74075972
ClinicalTrials.gov identifier
EudraCT number
Public title Modified Pilates as an adjunct treatment for urinary incontinence
Scientific title Modified Pilates as an adjunct to standard physiotherapy care for urinary incontinence: a pilot study
Acronym N/A
Serial number at source 12421
Study hypothesis Urinary incontinence is a distressing condition affecting more than 5 million women in the UK. Treatment usually involves pelvic floor exercises (pelvic floor muscles are those that control continence mechanisms). More recently Modified Pilates (MP) has been suggested as an additional means of improving symptoms and the quality of life of sufferers. MP is a mind-body technique involving slow controlled movements focusing on posture and breathing.

However, no research has evaluated the effectiveness of MP in a group setting for patients suffering from urinary incontinence.

To properly evaluate the effectiveness of MP a large randomised clinical trial will be necessary. In preparation we are planning a smaller (pilot) study to provide some early information, and help design the larger study.

In the pilot study 100 women will be randomly assigned to two groups:
Group 1 will receive pelvic floor exercises and lifestyle advice only
Group 2 will attend a 6 week course of MP classes in addition to receiving pelvic floor exercises and lifestyle advice

Participants in the two groups will be matched according to their height/weight ratio and severity of symptoms.

Both groups will be assessed at the start of the study, when they have completed their treatment, and 5 months later.

Measures will include severity of symptoms, frequency of incontinence, quality of life, self-and number of individual treatment sessions. Some participants will also be interviewed about their experiences of the treatments to explore perceived benefits and limitations.

Findings will inform design of the larger trial, provide information about the feasibility of offering MP to this patient group, and produce preliminary findings about its effectiveness. Findings will be sent to patient and professional interest groups and to service commissioners.

More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=12421
Lay summary Not provided at time of registration
Ethics approval First MREC, 18 July 2012 ref: 12/EE/0241
Study design Randomised interventional study
Countries of recruitment United Kingdom
Disease/condition/study domain Renal and Urogenital Disease
Participants - inclusion criteria 1. Women aged 18 and over
2. Diagnosed with stress, urge, or mixed UI (defined by Abrams et al [25])
3. Medically fit to perform physical activity
Participants - exclusion criteria 1. Aged under 18 years
2. No UI diagnosis
3. Unable to actively contract pelvic floor muscles
4. Suffering faecal incontinence
5. Pregnant
6. History of pelvic malignancy
7. Received gynaecological surgery in previous 6 months
8. Given birth in previous 6 months
9. Disease of Central Nervous System (e.g. Multiple Sclerosis, Cerebrovascular accident)
10. Unable to walk without walking aid
11. Having insufficient mental capacity to complete questionnaires and/or follow exercise instructions (according to the principles of the Mental Capacity Act 2005)
Anticipated start date 05/10/2012
Anticipated end date 04/02/2014
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants UK Sample Size: 100
Interventions Modified Pilates (MP)
Treatment usually involves pelvic floor exercises (pelvic floor muscles are those that control continence mechanisms). The intervention group receives pelvic floor exercises and modified pilates (MP). MP is a mind-body technique involving slow controlled movements focusing on posture and breathing.
Primary outcome measure(s) 1. Sympton severity index (SSI)
2. Incontinence related quality of life
3. Rosenberg self esteem index
Secondary outcome measure(s) No secondary outcome measures
Sources of funding NIHR Research for Patient Benefit Programme (UK) ref: PB-PG-1010-23220
Trial website
Publications
Contact name Prof  Berthold  Lausen
  Address University of Essex
Wivenhoe Park
  City/town Colchester
  Zip/Postcode CO4 3SQ
  Country United Kingdom
  Email blausen@essex.ac.uk
Sponsor Colchester Hospital University NHS Foundation Trust (UK)
  Address Colchester General Hospital
Colchester District General Hospital
Charter Way Turner Road
  City/town Colchester
  Zip/Postcode CO4 5JL
  Country United Kingdom
  Sponsor website: http://www.colchesterhospital.nhs.uk/
Date applied 12/12/2012
Last edited 12/12/2012
Date ISRCTN assigned 12/12/2012
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